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For peer review only
Evaluation of the feasibility and acceptability of ‘Care for stroke’ intervention in India: A Smartphone-enabled Carer-
supported Educational intervention for management of disability following stroke.
Journal: BMJ Open
Manuscript ID: bmjopen-2015-009243
Article Type: Research
Date Submitted by the Author: 30-Jun-2015
Complete List of Authors: K, Sureshkumar; Public Health Foundation of India, SACDIR; London School of Hygiene and Tropical Medicine, International Center for Evidence in Disability Gudlavalleti, Murthy; London School of Hygiene & Tropical Medicine, CRD Natarajan, Subbulakshmy; VHS Hospital, T.S Srinivasan Institute of Neurological Sciences C, Naveen; Indian Institute of Public Health - Hyderabad, Biostatistics Goenka, Shifalika; Indian Institute of Public Health Delhi, Public Health Kuper, Hannah; The London School of Hygiene & Tropical Medicine, Clinical Research
<b>Primary Subject Heading</b>:
Public health
Secondary Subject Heading: Rehabilitation medicine, Research methods, Health services research, Geriatric medicine, Global health
Keywords:
World Wide Web technology < BIOTECHNOLOGY & BIOINFORMATICS, PUBLIC HEALTH, Stroke < NEUROLOGY, REHABILITATION MEDICINE, GERIATRIC MEDICINE, Health informatics < BIOTECHNOLOGY & BIOINFORMATICS
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Evaluation of the feasibility and acceptability of ‘Care for stroke’ intervention in
India: A Smartphone-enabled Carer-supported Educational intervention for
management of disability following stroke.
K Sureshkumar1, GVS Murthy2, N Subbulakshmy 3, C Naveen4, Shifalika Goenka 5 Hannah
Kuper 6
Corresponding Author:
Sureshkumar Kamalakannan
Department of Clinical Research,
Faculty of Infectious & Tropical Diseases,
London School of Hygiene and Tropical Medicine,
Keppel Street, London,
WC1E 7HT.
Email: [email protected]
Phone: +91 9840772381, +91 9676333412
Authors
1. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected] Phone: +91 9840772381,
+91 9676333412
2. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected]
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3. T.S Srinivasan Institute of neurological Sciences, VHS Hospital, Rajiv Gandhi Salai,
Taramani Chennai, 600113. [email protected]
4. Indian institute of Public Health (Pubic Health Foundation of India) Hyderabad, Plot
1 ANV Arcade, Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad,
Telangana, 500033. [email protected]
5. Indian Institute of Public Health (Public Health Foundation of India), Delhi, Plot no.
34, Sector-44, Institutional Area, Gurgaon-122002, Haryana, India.
6. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected]
Keywords
1. Acceptability
2. Disability
3. Feasibility
4. Mhealth
5. Rehabilitation
6. Stroke
Word Count: Manuscript: - 3919
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Abstract:
Objectives:
1. Identify operational issues encountered by the study participants
2. Evaluate the feasibility and acceptability of the intervention
Setting: Community based rehabilitation for stroke survivors discharged from a
Multispecialty tertiary hospital in Chennai, India.
Participants: 30 Stroke survivors and their caregivers participated in the field-
testing and another 30 stroke survivors and their caregivers participated in pilot-
testing of the intervention. All the participants were south Indians.
Inclusion criteria:
Adults (≥18 years); Recent diagnosis of first ever stroke (FES); minor and moderate
severity; medically stable; requiring assistance of one person; residing with a
primary caregiver.
Exclusion criteria:
Participants with NIH score > 15; severe cognitive difficulties; severe communication
problem; severe co-morbidities; functionally dependent due to pre-existing
conditions; without primary caregiver.
Interventions: ‘Care for stroke’ is a Smartphone-enabled, educational intervention
for management of physical disabilities following stroke. The intervention was
provided to the stroke survivors to be used at home for two weeks during field-
testing and for four weeks during pilot-testing.
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Primary and secondary outcome measures: Feasibility and acceptability of the
intervention was the primary outcomes evaluated in this study. In addition, clinical
outcome measures such as the Barthel index and Modified Rankin scale was also
used.
Results: The field-testing identified some key concerns about connectivity, video
streaming, and picture clarity, quality of the videos and functionality of the
application. Findings from the pilot-testing showed that the ‘care for stroke’
intervention was successful. Over 90% of the study participants felt that the
intervention was relevant, comprehensible and useful. Over 95% of the stroke
survivors and all the caregivers (100%) rated the intervention to be excellent and
very useful. These findings were supported through the qualitative interviews.
Conclusion: Evaluation indicated that the ‘Care for stroke’ Intervention was feasible
and acceptable in an Indian context, and an assessment of effectiveness is now
warranted.
Article Summary:
Strengths of this study:
1. Phased approach to the development and evaluation of the intervention
2. Use of mixed research methods for evaluation of the intervention
Limitations of this study:
1. Recruitment of participants from only one centre
2. Stringent inclusion criteria for participant recruitment
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Background:
Each year, about 15 million people suffer stroke globally. One third of these stroke
survivors experience permanent disability (1). The increase in aging population and
the raising prevalence of risk factors for stroke will further increase the number of
people suffering from stroke-related disabilities (2). Projections by the World Health
Organization (WHO) show that the disability adjusted life years (DALYs) lost to
stroke will rise from 38 million in 1990 to 61 million by 2020 (1). These projections
imply an overwhelming global demand for stroke rehabilitation services (3). This is
especially the situation in low and middle income countries (LMICs) which bears a
substantial amount of the global burden of stroke (4) yet has few rehabilitation
services available.
‘Care for stroke’ is a web-based, Smartphone-enabled, caregiver-supported,
educational intervention for management of physical disabilities following stroke.
The intervention was developed to draw the principles of medical sciences and
information technology together to address the gaps in access to stroke rehabilitation
services for the stroke survivors in a systematic way as recommended by the MRC (5-
7). The intervention is developed with a special focus on LMICs and contexts where
the resources for rehabilitation are very limited. To our knowledge, there are no
stroke rehabilitation interventions enabled through Mhealth platform available and
relevant to the context of LMICs, such as India, where the resources for rehabilitation
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are very limited and the unmet needs of the stroke survivors are substantial.
Therefore we aimed to assess the feasibility and acceptability of this newly
developed rehabilitation intervention in Indian context.
Primary objectives of the evaluation:
3. Identify operational issues encountered by the study participants and revise the
intervention as required.
4. Evaluate the feasibility and acceptability of the intervention among the stroke
survivors and their caregivers.
Methods:
Participant selection and recruitment
The newly developed ‘care for stroke’ intervention was evaluated with a sample of
60 adult stroke survivors and their caregivers living in Chennai, South India (30
pairs of stroke survivors and their caregivers for field-testing and 30 pairs for pilot-
testing). These stroke survivors were previously treated for their stroke at the T.S
Srinivasan Institute of Neurological Sciences, VHS Multi-specialty hospital, Chennai.
Study participants were purposively selected from the hospital records and they
were invited to the hospital for a follow-up. During the follow-up consultation, the
stroke survivor was assessed for their eligibility to participate in the study by a
neurologist. If the participant was found eligible, they were provided a detailed
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background about the study and its purpose by the investigator (SK). Informed
written consent was obtained from those who accepted to participate in the study.
The inclusion criteria were
• Adults (≥18 years)
• Recent diagnosis of first ever stroke (FES) as defined by the WHO (8) within
3-6 weeks prior to the recruitment.
• Severity of stroke: minor and moderate (score 1-15, according to the NIH
stroke scale (9-11)
• Stroke survivor medically stable (reaching a point in medical treatment
where life-threatening problems following stroke have been brought under
control)
• Post-stroke functional status of the stroke survivor: Requiring assistance of
at least one person to perform basic activities of daily living including
transfers, self- care and mobility
• Stroke survivor residing with a primary caregiver (family member) at home
The exclusion criteria will be
• Participants with NIH score > 15
• Severe cognitive difficulties (NIH stroke scale components for cognition) (11)
• Severe communication problem
• Severe co-morbidities (severe psychiatric illness, hearing loss, vision loss)
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• Stroke survivor - functionally dependent due to pre-existing conditions
• Stroke survivor who do not have a primary caregiver
• Stroke survivors who were unwilling / unable to adhere to the study protocol
• Participants who do not qualify the training requirements (operation of
Smartphone)
About the Intervention
The intervention was delivered through a Smartphone and included information
about stroke and the ways to manage post-stroke disabilities. This was provided
through text and videos, all in the Tamil language. Further details about the ‘care for
stroke’ intervention have been described earlier (12).
Training and administration of the intervention
The educational intervention was pre-loaded onto the Smartphone. The stroke
survivor and their caregiver received 20-30 minutes training from the investigator to
access and use the intervention from the Smartphone. The participants were then
provided with the Smartphone intervention and asked to try it out on their own. An
errorless attempt to retrieve the required part of the intervention from the
Smart-phone for more than 3 attempts was considered to be a successful training.
After ensuring that the participant (either the stroke survivor or their caregiver)
could independently access the intervention, the intervention was provided to the
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participants for use at their home for two weeks during the field-testing phase and
for four weeks during the pilot-testing phase. The caregivers of stroke survivors
selected for this study were asked to support the stroke survivors in accessing the
intervention from the Smartphone as and when required.
Direct Observation and interviews during field-testing
Utilization of the Smartphone-enabled intervention and the support provided by the
caregivers to the stroke survivors was assessed by the investigator (SK) using
direct observation techniques with an observation checklist and short unstructured
interviews related to the objectives of the field-testing at participant’s home during
this phase. Key issues assessed included:
a. Relevance and comprehensibility
b. Operational difficulties and user-friendliness
c. T e c h n i c a l issues
d. Training needs
Assessment of feasibility and Acceptability:
Feasibility and acceptability of the intervention was assessed primarily through a
semi-structured questionnaire administered to the stroke survivors and the primary
care givers. Majority of the questions were related to satisfaction and patient
experience. The questionnaire schedule was developed, translated and pilot-tested
before being administered to the stroke survivors and primary care givers. In
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addition to this, participants were also interviewed with specific open-ended
questions related to the objectives of the pilot-testing.
Assessment of clinical outcomes:
Independence in activities of daily living was assessed using Barthel Index (BI) (13)
and disability was assessed using the Modified Rankin Scale (MRS) (14). We carried
out this assessment to look at the feasibility of using these outcome measures in a
larger trial of the intervention in the future
Analysis of outcome measures:
Pre-intervention and Post-intervention scores for Barthel Index and Modified Rankin
Scale were analysed using the paired, student T-test method.
Results of the field-testing:
The demographic and clinical characteristics of the stroke survivors and their
caregivers are described in Table 1.
Abilities of the participants to access the Intervention from a Smartphone:
Stroke survivors:
Among 30 stroke survivors selected for the field-testing, 37% (11 participants) were
using Smartphones prior to their stroke. Seven stroke survivors (6 men and 1
woman) were independently accessing the intervention through the Smartphone,
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without any support from their caregivers. All remaining participants were
supported by their caregivers to use the intervention – especially to operate the
Smartphone and access the required videos to be watched. Stroke survivors
preferred to use their affected hand to hold the Smartphone (Stabilise the
Smartphone) and operate the Smartphone using their unaffected hand. Most often,
the stroke survivors preferred to watch the videos first, understand it and then
practice it later at some point of time during the same day. Caregivers generally
directed the stroke survivors to watch videos that were interconnected. Very few
(three) stroke survivors preferred to use headphones to listen to the audio while
watching the videos.
Caregivers:
Among the caregivers included in field-testing, 93% of them were Smartphone users
prior to the intervention and 70% of them owned a Smartphone. None of the
caregivers who were trained had issues with operation of the Smartphone and
accessing the intervention. Their age, possession of a Smartphone and previous
experience of using a Smartphone makes caregiver- support, an important aspect of
the process.
Technical/Operational Issues encountered during field-testing
Operational issues encountered by some of the participants included
1. Poor Connectivity inside the home
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2. Video streaming delay due to low 3G data allowance.
3. Low Audio Levels (e.g. participant resided in noisy areas).
4. English Version not understandable, and Tamil needed.
5. Sliding Interface Function not working well.
6. Clarity of the Pictures inadequate.
In addition, five stroke survivors and fifteen caregivers expressed that they required
exclusive training and an operational manual to learn and access the intervention
from the Smartphone.
Findings from the field testing provided useful information to identify operational
difficulties of the participants in using the intervention in their actual environment.
These findings were shared with the expert group consisting of experts in the field of
neuro- rehabilitation from various professional health disciplines. After receiving
their feedback on the results of the field-testing and their advice, the preliminary
field-tested version of the ‘Care for stroke’ Intervention was revised. The intervention
was then finalized for the pilot-testing of its feasibility and acceptability in an Indian
context.
Results of the Pilot-testing:
The demographic and clinical characteristics of the stroke survivors and their
caregivers are described in Table 2 and 3 respectively.
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Feasibility for recruitment:
Study recruitment took place from December 2014 – February 2015. We identified 46
stroke survivors from the hospital records, and 30 were finally recruited (cause of
exclusion: death – 2; lack of contact details – 2; ineligible – 4; resided far from
hospital – 4; refusal – 4).
Feasibility for training and utilisation:
Nearly 80% (n=24) of the stroke survivors felt that they required support from their
caregivers to use the intervention, 14% said they could manage it by themselves and
3% stated that they required additional training to access it themselves. In contrast,
77% (n=23) of the caregivers stated that they managed the application themselves,
13% required support from other caregivers at home and 7 % of the required further
training. Details of the training needs and pattern of utilization by study participants
are provided in table – 4.
Smartphone utilisation among study participants:
Almost 90% of the stroke survivors had a Smartphone at home and over 40% of them
had mobile and broad band internet connections at home prior to the intervention.
Around 25% of the stroke survivors owned a Smartphone for themselves. Around
70% of the primary caregivers own a Smartphone and about 60% of them use all the
features of a Smartphone. All study participants had at-least one member in the
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family who supported the stroke survivor and one who had thorough knowledge
and experience of using a Smartphone.
Relevance of the Intervention:
All participants reported that the videos were very relevant to their rehabilitation
needs following stroke. Over 95% of the stroke survivors felt that the intervention
was most relevant to their current rehabilitation needs. More than 75% of the carers
expressed that the intervention was definitely relevant to the needs of the stroke
survivors.
Although half of the stroke survivors included in the study was functionally
independent, they still found the intervention very relevant to them. All the
participants found the “information about stroke” section very relevant to them in
terms of gaining awareness about the warning signs of stroke and knowledge about
stroke, its impact and various aspects of recovery following a stroke (Figure 1). The
caregivers especially expressed that they were gaining confidence and motivation to
support the stroke survivor in their family after watching the videos.
Comprehensibility of the intervention
When the study participants were asked about the overall comprehensibility of the
intervention, nearly 65% of stroke survivors and over 75% of the carers felt that the
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intervention was easily comprehensible. Participants reported that this was
especially because of the people in the videos and the language in which the audio
descriptions were presented.
The stroke survivors and the caregivers expressed that they were able to understand
the Webpages even through the photographs. None reported problems in either
understanding the action videos or the voice over that was being given along with
the action videos. The participants expressed that high definition videos and very
simple use of the language in the videos helped them comprehend the intervention
at ease.
Stroke survivors said that they actually enjoyed learning about the Do’s and Don’ts
after stroke and to manage their daily living from the videos. They explained that
they were able to comprehend the recovery process and the ways to prevent another
stroke after watching the intervention videos.
A 65 year old woman with mild stroke explained:
“I was so depressed because of this problem. I did not know whether this could come back like
heart attack. Watching the videos about risk factors was such a relief. Now I understood that,
if I control my sugar problem and have proper balanced diet. I can be away from another
stroke”
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User-Friendliness of the Smartphone-enabled intervention:
The Intervention was loaded onto a latest Smartphone – Micromax Canvas A102
Doodle3. This Smartphone had configurations appropriate to access the intervention
with good connectivity, streaming speed and picture clarity, and was relatively
cheap. Other key aspects of user-friendliness of the intervention included
1. Light weight of the Smartphone (584 gm).
2. Wide screen (7”)
3. Video/Picture Quality and detailing (High Definition)
4. Streaming Speed (On Demand - Content Delivery Network [CDN])
5. Application Design and Access features (Based on the felt-needs of the stroke
survivors)
A 52 year old woman with moderate stroke expressed:
“It’s good that this is in a video format – It would be very difficult for me to read or
understand formal Tamil dialects with the problems in my eyes. I always like to watch TV
and hence I quite like the idea of teaching us ‘what to do’ through videos. Compared to
reading from a book, this is not so boring as well”
Usefulness of the intervention videos:
Nearly 60% of the stroke survivors and 50% of their carers stated that the
intervention was very useful to them. The overall rating that the participants
provided for the usefulness of the intervention is presented in figure – 2. Stroke
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survivors explained that the digitized format of the intervention was very
motivating. They felt that the intervention has very useful information about their
problem, the causes for their stroke and the ways to manage their problems by
themselves. A 54 year old woman with moderate stroke and who was unable to
transfer or walk without support said:
“I can now move from my bed to chair with some support from my sister. I am very happy to
have achieved this. I saw the videos on ‘how to move from one place to another with support’
and I practiced it with my sister. Thank you for helping me with your videos. I am planning
to learn more from it “
Most of the participants felt that the videos were self-explanatory. The carers
explained that the stroke survivors were able to accept the importance of engaging in
their daily living tasks and becoming as independent as possible in their lives.
Acceptability of the Intervention
Two key features of the intervention that was most strongly valued by most of the
study participants were
1. The Tamil audio descriptions of the intervention (local language)
2. The content of the intervention, especially the exercises and daily living task
sections, explained through demonstration by individuals, who resembled not
only as stroke patients but also as people from Tamilnadu.
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A 45 year old man who suffered a mild stroke described:
“I didn’t know that something like this is available in Chennai, I thought all these were in
foreign countries. My son showed me some videos where doctors are speaking in English and
I could not understand much. But I was able to understand many things from these videos on
the phone – it was in Tamil so it was very easy”
Stroke survivors expressed that they felt motivated and encouraged to see the actual
performance of daily living tasks using one-handed techniques by someone like
them in the videos.
A 60 year old man who was experiencing a mild stroke described:
“I am surprised that a person with stroke can do things by himself with the strong hand. It’s
eye opening. I felt, why I can’t try. I am now trying some of the tasks that I saw from the
videos, especially to use my hand to eat and dress myself.”
Acceptability of the Smartphone-enabled Application:
Stroke survivors found the portability of the intervention through Smartphone was
very useful for them to watch the intervention videos from anywhere they wanted.
They felt that it was very comfortable for them to carry the Smartphone anywhere
they wanted. Stroke survivors also expressed that aspect of portability of the
intervention, was very helpful for them to watch the intervention privately (at home
or any other places) without disturbing others. Stroke survivors expressed that they
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never felt shy to watch the videos related to their problems because none could
actually notice or know what they were watching on the Smartphone.
“It’s a big family – we are nine people in a single home and one TV for all of us. The TV room
will be busy all the time with lots of family members. This was one important reason why I
prefer the Smartphone instead of a DVD. I take this to any room or even my workplace and
watch, it’s convenient to carry and comfortable to watch – no one knows what I am watching.
Otherwise people will feel pity about my situation”
Caregivers expressed that the Smartphone option requires very minimal physical
effort in terms of carrying it or operating it.
A 65 year old gentleman who supports his wife who has a moderate stroke
explained:
“To get up from your place, go near TV to switch on, find the remote, give connections etc. It
requires lots of work. I have to walk, bend and lift. I can’t do all this with my own problems –
this arthritis. This Smartphone that you gave is a nice choice. Nothing other than movement
of fingers to touch the screen is required. My wife watched it even when she was on bed
sometimes.”
Caregivers also appreciated the size of the Smartphone screen, which was big
enough to watch the videos comfortably without straining the eyes. They expressed
that they can also access the intervention from their own Smartphone.
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Caregivers found the repeatability of the intervention through simple touch and
slide options of the Smartphone application very comfortable to help the stroke
survivor to remember important information and to reinforce to them about the
importance of recovering from stroke. Caregivers also appreciated the design of the
application which provides access to any number of users from anywhere in the
world to watch the intervention videos just by registering them onto the application.
57 year old lady who supported her husband with moderate stroke said:
“My daughter, who lives in Singapore, wanted to know what this phone thing is all about. So
we shared the details with her and asked her to watch it. Next day she called us and enquired
whether we are watching it or not and she calls every day to find out what we watched.”
Overall Likeableness of the intervention
When the study participants were asked about the likeableness of the intervention,
more than 55% of the stroke survivors and about 90% of their carers expressed that
the intervention is definitely likeable. About 40% of the stroke survivors and 10% of
the carers felt that the intervention is likeable to a great extent (Figure – 3).
Overall rating for the Intervention:
More than 50% of the stroke survivors and 65% of the carers rated the Smartphone-
enabled intervention as excellent. Remaining proportion of participants rated the
intervention as very useful (Figure -4).
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Suggestions by participants:
A major concern voiced by a few participants was the connectivity to the internet,
since the videos were streamed online through the web-based application service.
Few participants also felt that the intervention could have been with them for some
more time and others reported that this kind of intervention should have been given
to them when they were first hospitalised for stroke. There was request from some
participants for a follow-up home visit by a member of the team to reassure whether
they are in the right direction towards recovery. Some participants suggested that
this intervention should be provided to every stroke survivor in every hospital and
also to the public to prevent further strokes and its recurrence.
Clinical Outcomes:
Results from the analysis show that there was a statistically significant improvement
in the scores of Barthel Index and MRS from before to after the intervention period
(Table - 5). Both these standardised tools appear to be feasible for use in future
clinical trials and effectiveness evaluation of this intervention.
Discussion:
The evaluation revealed that there was minimum one Smartphone user and one own
Smartphone in a participant’s family. This indicates the availability and degree of
Smartphone penetration in a city like Chennai which makes it potentially feasible for
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the Smartphone-enabled carer-supported ‘Care for stroke’ intervention to be widely
used in the future. The intervention was also found to be highly relevant, easily
comprehensible, substantially useful, largely likeable and satisfying to a greater
extent. This implies the level of acceptability of the intervention among the study
participants. Lack of availability and accessibility to this kind of informational or
educational interventions could be an important reason for the ‘care for stroke’
intervention to be highly acceptable among its users.
Though, the results from assessment of clinical outcomes were statistically
significant, the amount of clinical gains obtained by the stroke survivors during the
intervention period was relatively small (15), and not necessarily attributable to the
intervention. Given the clinical significance and the small size of the sample used in
the pilot-testing, the statistical results obtained from the outcome measures have to
be carefully interpreted (16).
Field-testing of the intervention facilitated the investigators to address key
operational uncertainties in the intervention that could have affected its feasibility
and acceptability. It also provided an opportunity to review, and revise the
intervention before it was pilot-tested. Pilot-testing of the intervention prior to its
effectiveness evaluation assisted investigators to understand the factors that could
affect feasibility and acceptability of the intervention. It provided valuable
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information that could be used to plan and organize rigorous effectiveness
evaluation of the intervention in the future. This phased approach to the
development of the intervention facilitated, provision of proper consideration to the
practical aspects of evaluation and thereby ensuring an assurance that the
intervention could be delivered as intended in the future (17).
Accommodating multiple centres from the same geographical location (multi-
centres) for recruitment of participants for future studies could hasten the process of
participant recruitment and thereby the evaluation process. Future studies could
broaden the criteria for participant inclusion to more easily achieve the desired
sample size and also to stratify the effects of the intervention on different groups and
sub-groups of stroke survivors.
Conclusion:
Evaluation of the ‘Care for stroke’ Intervention establishes the feasibility in an Indian
context and acceptability among the stroke survivors and their caregivers. This
makes it possible for the investigators to affirm that provision of a Smartphone-
enabled, carer-supported educational intervention for management of post-stroke
disabilities could be a potential strategy to meet the growing need for stroke
rehabilitation services in settings were rehabilitation resources are very limited.
Adoption and modification of the ‘care for stroke’ intervention with due importance
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to the cultural aspects of the target population could potentially aid in bridging the
gaps in access to stroke rehabilitation services not just in India but also in countries
where the rehabilitation needs of the stroke survivors are substantial.
Authors’ Contributions
Sureshkumar.K (SK) conceived, designed and drafted the manuscript. Prof GVS
Murthy and Dr Hannah Kuper played a crucial role in conception of the research
study and provided substantial guidance in designing and conducting evaluation.
Dr Shifalika Goenka and Dr Subbulakshmy N provided advice related to conception
and actual conduct of the evaluation. Naveen C assisted in carrying out the
quantitative analysis.
Competing Interests
The authors declare that they have no competing interests, financial or non-financial.
Funding
This work was supported by a Wellcome Trust Capacity Strengthening Strategic
Award to the Public Health Foundation of India and a consortium of UK
universities.
Data Sharing Statement: No additional data are available.
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Ethics Approval
The ethics approval for the study was obtained from the institutional ethics
committee at the London School of Hygiene and Tropical Medicine, Indian institute
of Public Health – Hyderabad and Voluntary Health Services Hospital.
Acknowledgement
We thank Wellcome-trust and Public Health Foundation of India for funding the
research study and also the student to undertake the research study as a part of his
doctoral study at the London School of Hygiene and Tropical Medicine. We thank
the ethics committee of the London School of Hygiene and Tropical Medicine, PHFI-
Indian Institute of Public Health - Hyderabad and The Voluntary Health Services
Hospital for granting scientific and ethics approval to conduct this research study.
We thank the members of the expert committee who provided valuable advice on
the development and evaluation of the intervention. We thank the colleagues from
TINS VHS who patiently assisted in conducting the evaluation. We also thank
consultants from Suchir softech and Selva photography for revising the application
and digitized content during the evaluation.
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References:
1. Mackay J, Mensah G. The Atlas of heart disease and stroke, WHO 2004.
http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.
pdf: The Atlas of Heart Disease and Stroke. Geneva, Switzerland, World
Health Organization.
2. World Health Organization (WHO), 2005, Disability and rehabilitation WHO
action plan 2006–2011, viewed 09 June 2015, from
http://www.who.int/disabilities/publications/dar_action_plan_2006to2011.pdf
3. World Health Organization (WHO), 2011, World disability report, WHO,
Geneva.
4. Ferri CP, SChoenborn C, Kaira L, et al. Prevalence of stroke and related
burden among older people living in Latin America, India and China.
J Neurol Neurosurg Psychiatry 2011; 82:1074-1082.
5. Peter Craig, Mark Petticrew, Developing and evaluating complex
interventions: Reflections on the 2008 MRC guidance, International Journal of
Nursing Studies, Volume 50, Issue 5, May 2013, Pages 585-587, ISSN 0020-
7489,http://dx.doi.org/10.1016/j.ijnurstu.2012.09.009.
6. Craig P. Foreword. In: Richards D, Rahm Hallberg I, editors Complex
interventions in health: an overview of research methods. Routledge, 2015.
7. Craig P, Cooper C, Gunnell D, Haw S, Lawson K, Macintyre S, Ogilvie D,
Petticrew M, Reeves B, Sutton M, Thompson S. Using natural experiments to
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evaluate population health interventions: new Medical Research Council
guidance. Journal of Epidemiology & Community Health 2012;66:1182-1186
8. WHO MONICA Project Investigators. The World Health Organization
MONICA Project (Monitoring trends and determinants in cardiovascular
disease). J Clin Epidemiol 1988; (41): 105-114.
9. NIH Stroke Scale Training, Part 2. Basic Instruction. Department of Health
and Human Services. The National Institute of Neurological Disorders and
Stroke (NINDS), 2010.
10. Ver Hage et al. The NIH stroke scale: a window into neurological status.
Nurse.Com. Nursing Spectrum (Greater Chicago). 2011; 24(15):44-49.
11. Cumming TB, Blomstrand C, Bernhardt J, et al. The NIH stroke scale can
establish cognitive function after stroke. Cerebrovasc Dis. 2010; 30(1):7-14.
12. Sureshkumar, K, Murthy, GVS, Goenka, S, et al. Development and evaluation of a
Smartphone-enabled, caregiver-supported educational intervention for management of
physical disabilities following stroke in India: protocol for a formative research study. BMJ
Innovations 2015; 1:117-126.
13. Mahoney F. Barthel D. Functional evaluation: the Barthel Index. Md Med
J.1965; 14 :61–65.
14. Van Swieten JC, Koudstaal PJ, Visser MC, et al. Interobserver agreement for
the assessment of handicap in stroke patients.Stroke. 1988; 19: 604–607.
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15. Sedgwick Philip. Clinical significance versus statistical significance BMJ 2014;
348: g2130.
16. Sedgwick Philip. The importance of statistical power BMJ 2013; 347: f6282.
17. Moore Graham, F Audrey Suzanne, Barker Mary, Bond Lyndal, Bonell Chris
et al. Process evaluation of complex interventions: Medical research council
guidance BMJ 2015; 350: h1258.
Figure Legends
1. Figure: 1 Interesting sections of the intervention for the participants
2. Figure -2: Overall Rating for the usefulness of intervention
3. Figure – 3: Overall likeableness of the intervention
4. Figure – 4: Overall rating for the ‘care for stroke’ intervention
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Tables
Table: 1 Demographic and Clinical Characteristics of the stroke survivors
Characteristics
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender: 20 (67%) 10 (33%) 30 (100%)
Age: Mean (SD) 51.3 (14.6) 60 (13.6) 54.2 (14.7)
Education: 18 (90%) 8 (80%) 24 (80%)
Primary school or higher
Marital status 18 (90%) 9 (90%) 50 (90%)
Working prior to stroke: 20 (100%) 6 (60%) 26 (87%)
Currently working: 10 (50%) 5 (50%) 15 (50%)
First ever stroke: 20 (100%) 10 (100%) 30 (100%)
Stroke type:
Ischaemic: 18(90%) 9(90%) 47 (90%)
Haemorrhagic: 2 (10%) 1 (10%) 3 (10%)
Stroke severity:
Minor: 9 (45%) 3 (30%) 12 (40%)
Moderate: 11 (55%) 7 (70%) 18 (60%)
Affected side:
Right 12 (60%) 6 (60%) 18 (60%)
Left 8 (40%) 4 (40%) 12 (40%)
Level of dependence:
Independent: 11 (55%) 4 (40%) 15 (50%)
One Person Assistance: 9 (45)% 6 (60%) 15 (50%)
Receiving Physiotherapy 6 (30%) 2 (20%) 8 (27%)
Smartphone users 8 (53%) 3 (20%) 11 (37)%
Use of Assistive aids: 4 (20%) 5 (50%) 9 (30%)
Demographic Characteristics of the Caregivers
Characteristics Male Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender: 15 (50%) 15 (50%) 30 (100%)
Age: Mean (SD) 34.6 (±6.7) 28.6 (±7.5) 31.63 (±7.66)
Education Primary school or higher 15 (100%) 15 (100%) 30 (100%)
Employed: 14 (93%) 7 (47%) 21 (70%)
Primary caregivers: 9 (60%) 7 (47%) 16 (53%)
Own a Smartphone: 12 (80%) 9 (60%) 21 (70%)
Smartphone users 14 (93%) 13 (87%) 28 (93)%
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Table: 2 Demographic and Clinical Characteristics of the stroke survivors
Characteristics
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender: 18 (60%) 12 (40%) 30 (100%)
Age: Mean (SD) years 58 (±12.8)
years 57.8 (±8.8) years 57.9 (±11.27) years
Education: 17 (94.4%) 9 (75%) 26 (86.6%)
Primary school or higher
Currently married 18 (100%) 12 (100%) 30 (100%)
Working prior to stroke: 13 (72%) 3 (25%) 16 (53%)
Currently working: 2 (11%) 1 (8%) 3 (10%)
Unable to return to their usual
roles/routines: 11 (61%) 11 (92%) 22 (73%)
First ever stroke: 18 (100%) 12 (100%) 30 (100%)
Stroke type:
Ischaemic: 13(72%) 11 (92%) 24 (80%)
Haemorrhagic: 5 (28%) 1 (8%) 6 (20%)
Stroke severity:
Minor: 4 (22%) 4 (33%) 8 (27%)
Moderate: 14 (78%) 8 (67%) 22 (73%)
Affected side:
Right 10 (55%) 8 (33%) 18 (60%)
Left 7 (39%) 4 (67%) 11 (37%)
Both 1 (6%) 0 (0%) 1 (3%)
Involvement of Hand 15 (83%) 11 (92%) 26 (87%)
Level of dependence:
Independent-personal care 4 (22%) 3 (25%) 7 (23%)
One Person assistance needed 14 (78%) 9 (75%) 23 (77%)
Receiving Physiotherapy Services 4 (22%) 4 (33%) 8 (27%)
Using Mobility aids 2 (11%) 4 (33%) 6 (20%)
Own Smartphone 5 (28%) 2 (17%) 7 (23)%
Use Smartphone regularly 3 (17%) 0 (0%) 3 (17)%
Have Mobile Internet Connection 7 (39%) 6 (50%) 13 (43%)
Have Smartphone at home 15 (83%) 11 (92%) 26 (87%)
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Table: 3 Demographic Characteristics of the Caregivers
Characteristics
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender 11 (37%) 19 (63%) 30 (100%)
Age: Mean (SD) years 39.4 (±14) years 39.5 (±14) years 39.5 (±13.7) years
Education:
Primary school or higher 11 (100%) 18 (95%) 29 (97%)
Currently married 7 (64%) 15 (79%) 22 (73%)
Working/Studying 9 (82%) 18 (95%) 27 (90%)
Primary caregivers 7 (64%) 18 (95%) 25 (83%)
Own a Smartphone 12 (80%) 9 (60%) 21 (70%)
Smartphone users 7 (64%) 11 (58%) 18 (60%)
Other caregivers of the stroke
survivors at home:
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender 16 (47%) 14 (53%) 30 (100%)
Age: Mean (SD) years 30.6 (±8.6) years 26 (±6.6) years 28.5 (±7.9) years
Smartphone users: 16 (100%) 14 (100%) 30 (100%)
Smartphone owners: 14 (87%) 10 (71%) 24 (80%)
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Table - 4: Details of the participant responses from the satisfaction survey
Participants Initial impression about the intervention
Interesting
N (%)
Encouraging
N (%)
Motivating
N (%)
Consoling
N (%)
All
N (%)
None
N (%)
Stroke
survivors 7 (23.3%) 3 (10%) 1 (3.3%) 17 (56.7%)
2
(6.7%) 0 (0%)
Caregivers 9 (30%) 6 (20%) 10 (33.3%) 4 (13.3%) 1
(3.3%) 0 (0%)
Need for training and support
Support from
others
Can Manage
Myself Training
Training and support
from others Not sure
Stroke
survivors 24 (80%) 4 (13.3%) 1 (3.3%) 0 (0%) 1 (3.3%)
Caregivers 4 (13.3%) 23 (76.7%) 2 (6.7%) 0 (0%) 1 (3.3%)
Overall Confidence to use the Intervention
Definitely
Confident
Confident to
a greater extent
Confident to
some extent
Confident to
a small extent Not confident
Stroke
survivors 3 (10%) 9 (30%) 17 (56.7%) 1 (3.3%) 0 (0%)
Caregivers 17 (56.7%) 12 (40%) 1 (3.3%) 0 (0%) 0 (0%)
Utilisation pattern of the intervention
More than
once weekly
Whenever
possible
More than
one daily
whenever
necessary Did not watch
Stroke
survivors 15 (50%) 14 (46.7%) 1 (3.3%) 0 (0%) 0 (0%)
Caregivers 17 (46.7%) 9 (30%) 2 (6.7%) 5 (16.7%) 0 (0%)
Practicing the skills learnt from the intervention
Practice
Always
Practice
Frequently
Practice
Occasionally
Practice
Rarely
Never Practice
Stroke
survivors 7 (23.3%) 16 (53.3%) 6 (20%) 1 (3.3%)
0 (0%)
Caregivers 7 (23.3%) 15 (50%) 8 (26.7%) 0 (0%) 0 (0%)
Overall Usefulness of the intervention
Definitely
Useful
Useful to a
great extent
Useful to
some extent
Useful to a
small extent Not useful
Stroke
survivors 19 (63.3%) 9 (30%) 2 (6.7%) 0 (0%) 0 (0%)
Caregivers 9 (30%) 20 (66.7%) 1 (3.3%) 0 (0%) 0 (0%)
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Table - 5: Details from the analysis of the outcome measures
Outcomes
Pre-
Intervention
(Baseline)
Post-
intervention
(End point)
Mean Difference with
95% CI
Test for overall
effect
Barthel Index
Mean (SD) 57.8 (± 26.6) 70 (± 25.8)
-12.16
(-15.3, -9.00)
-7.86
P < 0.00001**
Modified Rankin Scale
Mean (SD) 3.2 (± 0.8) 2.7 (± 1.1)
0.53
(0.34, 0.72)
5.75
P < 0.00001**
**p < 0.05 significant difference in group
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Figures
Figure: 1 Interesting sections of the intervention for the participants
Figure -2: Overall Rating for the usefulness of intervention
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Figure – 3: Overall likeableness of the intervention
Figure – 4: Overall rating for the ‘care for stroke’ intervention
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Evaluation of the feasibility and acceptability of the ‘Care for stroke’ intervention in India: A Smartphone-enabled
Carer-supported Educational intervention for management of disability following stroke.
Journal: BMJ Open
Manuscript ID: bmjopen-2015-009243.R1
Article Type: Research
Date Submitted by the Author: 03-Sep-2015
Complete List of Authors: K, Sureshkumar; Public Health Foundation of India, SACDIR; London School of Hygiene and Tropical Medicine, International Center for Evidence in Disability Gudlavalleti, Murthy; London School of Hygiene & Tropical Medicine, CRD Natarajan, Subbulakshmy; VHS Hospital, T.S Srinivasan Institute of Neurological Sciences C, Naveen; Indian Institute of Public Health - Hyderabad, Biostatistics Goenka, Shifalika; Indian Institute of Public Health Delhi, Public Health Kuper, Hannah; The London School of Hygiene & Tropical Medicine, Clinical Research
<b>Primary Subject Heading</b>:
Public health
Secondary Subject Heading: Rehabilitation medicine, Research methods, Health services research, Geriatric medicine, Global health
Keywords:
World Wide Web technology < BIOTECHNOLOGY & BIOINFORMATICS, PUBLIC HEALTH, Stroke < NEUROLOGY, REHABILITATION MEDICINE, GERIATRIC MEDICINE, Health informatics < BIOTECHNOLOGY & BIOINFORMATICS
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Evaluation of the feasibility and acceptability of the ‘Care for stroke’ intervention
in India: A Smartphone-enabled, Carer-supported, Educational intervention for
management of disability following stroke.
K Sureshkumar1, GVS Murthy2, N Subbulakshmy 3, C Naveen4, Shifalika Goenka 5 Hannah
Kuper 6
Corresponding Author:
Sureshkumar Kamalakannan
Department of Clinical Research,
Faculty of Infectious & Tropical Diseases,
London School of Hygiene and Tropical Medicine,
Keppel Street, London,
WC1E 7HT.
Email: [email protected]
Phone: +91 9840772381, +91 9676333412
Authors
1. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected] Phone: +91 9840772381,
+91 9676333412
2. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected]
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3. T.S Srinivasan Institute of neurological Sciences, VHS Hospital, Rajiv Gandhi Salai,
Taramani Chennai, 600113. [email protected]
4. Indian institute of Public Health (Pubic Health Foundation of India) Hyderabad, Plot
1 ANV Arcade, Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad,
Telangana, 500033. [email protected]
5. Indian Institute of Public Health (Public Health Foundation of India), Delhi, Plot no.
34, Sector-44, Institutional Area, Gurgaon-122002, Haryana, India.
6. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected]
Keywords
1. Disability
2. Feasibility
3. Mhealth
4. Rehabilitation
5. Stroke
6. Smartphone
Word Count: Manuscript: - 4218
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Abstract:
Objectives:
1. Identify operational issues encountered by the study participants in using the
intervention.
2. Evaluate the feasibility and acceptability of the intervention.
Design: Mixed-methods research design
Setting: The study took place in participant’s home. Participants were selected from
a tertiary hospital in Chennai, South-India.
Participants: Stroke survivors and their primary caregivers treated and discharged
from the Hospital.
Intervention: ‘Care for stroke’ is a smartphone-enabled, educational intervention for
management of physical disabilities following stroke. It is delivered through a web-
based, Smartphone-enabled application. It includes inputs from stroke rehabilitation
experts in a digitized format.
Methods: Evaluation of the intervention was completed in two phases. In the first
phase, the preliminary intervention was field-tested with 30 stroke survivors for two
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weeks at home. In the second phase, the finalized intervention was provided to a
further 30 stroke survivors to be used in their homes with support from their carers
for four weeks.
Primary and secondary outcome measures:
The primary outcomes were
1. Operational difficulties in using the intervention.
2. Feasibility and acceptability of the intervention in an Indian setting.
Disability and dependency was assessed as secondary outcomes.
Results: The field-testing identified operational difficulties related to connectivity,
video streaming, picture clarity, quality of videos and functionality of the
application. The intervention was reviewed, revised and finalized before pilot-
testing. Findings from the pilot-testing showed that the ‘care for stroke’ intervention
was feasible and acceptable. Over 90% (n=27) of the study participants felt that the
intervention was relevant, comprehensible and useful. Over 96% (n=29) of the stroke
survivors and all the caregivers (100%, n=30) rated the intervention as excellent and
very useful. These findings were supported through the qualitative interviews.
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Conclusion: Evaluation indicated that the ‘Care for stroke’ intervention was feasible
and acceptable in an Indian context. An assessment of effectiveness is now
warranted.
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Strengths and limitations of this study:
• A Phased approach to the development and evaluation of the intervention
• Mixed research methods was used for evaluation of the intervention
• Recruitment of participants from only one centre
• Stringent inclusion criteria for participant recruitment
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Background:
Each year, about 15 million people suffer stroke globally. One third of stroke
survivors experience permanent disability (1). Increased population aging and the
rising prevalence of risk factors for stroke will further increase the number of people
suffering from stroke-related disabilities (2). Projections by the World Health
Organization (WHO) show that the disability adjusted life years (DALYs) lost to
stroke will rise from 38 million in 1990 to 61 million by 2020 (1). These projections
imply an overwhelming global demand for stroke rehabilitation services (3). This is
especially the situation in low and middle income countries (LMICs) which bears a
substantial amount of the global burden of stroke (4) yet has few rehabilitation
services available.
‘Care for stroke’ is a web-based, Smartphone-enabled, caregiver-supported,
educational intervention for management of physical disabilities following stroke.
This Mhealth intervention draws on the principles of both medical sciences and
information technology to address the gaps in access to stroke rehabilitation services
for stroke survivors in a systematic way, as recommended by the Medical Research
Council (MRC) (5-6). The intervention has been developed with a specific focus on
LMICs where the resources available for rehabilitation are very limited. To our
knowledge, there are no prior stroke rehabilitation interventions enabled through
Mhealth platforms both available and relevant to the context of LMICs, such as
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India, where the resources for rehabilitation are limited and the unmet needs of
stroke survivors are substantial. Therefore, it was decided to evaluate this newly
developed rehabilitation intervention in an Indian context.
This study was carried out as a part of a PhD that looked at development of a needs-
based educational intervention to manage disabilities following stroke in India. The
PhD research study was conducted in three phases. The research study protocol is
available elsewhere (7). This paper describes the field-testing and pilot-testing of the
intervention. The purpose of field-testing was to provide the newly developed
intervention to stroke survivors and their caregivers and assess any initial
operational difficulties experienced. This enabled revision and refinement of the
intervention before it was tested for feasibility and acceptability (pilot-testing).
Primary objectives of the evaluation:
1. Identify operational issues encountered by the study participants through
field-testing.
2. Revise the intervention based on the findings from the field-testing.
3. Evaluate the feasibility and acceptability of the intervention among the
stroke survivors and their caregivers through pilot-testing.
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Methods:
Mixed Methods Research Design:
This study applied mixed research methods, in order to collect more
comprehensive evidence regarding the research question. The mixed-methods
approach was specifically chosen because it is known to encourage the use of
multiple worldviews and is a pragmatic approach to research pertaining to
development of complex interventions (8).
Participant selection and recruitment
Only one hospital (T.S Srinivasan Institute of Neurological Sciences, VHS Multi-
specialty hospital in Chennai) provided permission to recruit participants. The
newly developed ‘Care for Stroke’ intervention was evaluated with a sample of 60
adult stroke survivors and their caregivers living in Chennai, South India (30 pairs
of stroke survivors and their caregivers for field-testing and 30 pairs for pilot-testing).
All were previously treated for their stroke at VHS hospital, which has an admission
rate of three – four stroke patients per week. Given the hospital admission rate and
the time that was available within the PhD. We were able to recruit only 30 pairs of
participants for field-testing and 30 pairs for pilot-testing.
Study participants were purposively selected from the hospital records and invited
to the hospital for follow-up. Contact details of participants were retrieved from their
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hospital records. During the follow-up consultation, the stroke survivor was
assessed for their eligibility to participate in the study by a neurologist. If the
participant was determined to be eligible, they were provided with detailed
background about the study and its purpose by the investigator (SK). Informed
written consent was obtained from those who agreed to participate in the study.
The inclusion criteria were
• Adults (≥18 years)
• Recent diagnosis of first ever stroke (FES) as defined by the WHO (9) within
3-6 weeks prior to the recruitment.
• Severity of stroke: minor and moderate (score 1-15, according to the NIH
stroke scale (10-11)
• Stroke survivor medically stable (reaching a point in medical treatment
where life-threatening problems following stroke have been brought under
control)
• Post-stroke functional status of the stroke survivor: Requiring assistance of
at least one person to perform daily activities such as transfers, self- care and
mobility (scoring less than the maximum score obtainable in one or more
components of the Barthel Index (12))
• Stroke survivor residing with a primary caregiver (family member) at home
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Further exclusion criteria were:
• Participants with NIH score > 15
• Severe cognitive difficulties (Scoring more than one (>1) in Orientation,
Executive function, Inattention and Language components of the NIH stroke
scale components for cognition) (13)
• Severe communication problem (Scoring more than one (>1) in Dysarthria
and Best Language component of the NIH stroke scale (10-11))
• Severe co-morbidities (severe psychiatric illness, hearing loss, vision loss)
• Stroke survivor - functionally dependent due to other pre-existing conditions
(amputation, fracture, dementia etc.)
• Stroke survivor without a primary caregiver
• Stroke survivor unwilling / unable to adhere to the study protocol
• Participants who did not meet the training requirements regarding
operation of a Smartphone
About the Intervention
The ‘Care for stroke’ intervention was delivered through a Smartphone and included
information about stroke and the ways to manage post-stroke disabilities. This was
provided through text and videos in the local Tamil language. The intervention is
web-based and hence requires an internet connection. Further details about the
intervention have been described earlier (14).
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Training and administration of the intervention
The educational intervention was pre-loaded onto the Smartphone. The stroke
survivor and their caregiver received 20-30 minutes training from the investigator
on access and use of the intervention via the Smartphone. Participants were then
provided with a Smartphone pre-loaded with ‘Care for Stroke’ intervention (i.e. a
smartphone along with the intervention loaded onto it) and asked to try it out on
their own. Three or more errorless attempts to retrieve the required part of the
intervention from the Smartphone were considered successful training.
Participants were asked to use this intervention at home for two weeks during the
field-testing phase and for four weeks during the pilot-testing phase. The caregivers
of stroke survivors selected for this study were asked to support the stroke
survivors in accessing the intervention from the Smartphone as and when required.
Direct Observation and interviews during field-testing
Utilization of the Smartphone-enabled intervention and the support provided by the
caregivers to the stroke survivors was assessed by the investigator (SK). Direct
participant observation (with observation checklist) and short unstructured
interviews related to the objectives of the field-testing were carried out at each
participant’s home during this phase. Key issues assessed included:
a. Relevance and comprehensibility
b. Operational difficulties and user-friendliness
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c. T e c h n i c a l issues
d. Training needs
Assessment of feasibility and Acceptability during pilot-testing:
Feasibility and acceptability of the intervention was assessed primarily through a
semi-structured questionnaire administered to stroke survivors and primary care
givers. The majority of questions in the questionnaire were related to satisfaction
and patient experience. The questionnaire predominantly included closed-ended
questions with ordered (Likert-Scale) responses. The frequency of each response
was calculated separately for each question in the questionnaire. The questionnaire
schedule was developed, translated and pilot-tested before it was administered. In
addition to this, participants were also interviewed with specific open-ended
questions related to the objectives of the pilot-testing. Participants’ responses to the
interview questions were transcribed verbatim and translated into English.
Transcribed data were then analysed using the Framework approach (15).
Assessment of clinical outcomes:
Independence in activities of daily living was assessed using the Barthel Index (BI) (12)
and disability was assessed using the Modified Rankin Scale (MRS) (16). We carried
out this assessment to investigate the feasibility of using these clinical outcome
measures in a future larger trial of the intervention.
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Analysis of clinical outcome measures:
Pre-intervention and Post-intervention scores for the Barthel Index and Modified
Rankin Scale were analysed using the paired, student T-test method.
Results of the field-testing:
The demographic and clinical characteristics of the stroke survivors and their
caregivers are described in Table 1.
Abilities of the participants to access the Intervention from a Smartphone:
Stroke survivors:
Among 30 stroke survivors selected for the field-testing, 37% (11 participants) used a
Smartphone prior to their stroke. During the field-testing, seven stroke survivors
(n=23.3%) (6 men and 1 woman) independently accessed the intervention through
the Smartphone. All remaining participants were supported by their caregivers to
access the intervention – especially in operating the Smartphone to access desired
videos. Three stroke survivors (10%) used headphones to listen to the audio while
watching the videos. Stroke survivors preferred to use their affected hand to hold or
stabilise the Smartphone and operate it using their unaffected hand. Most often,
stroke survivors preferred to watch the video first, understand it and then practice
the techniques shown at a later point.
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Caregivers:
Among the caregivers included in field-testing, 93.3% (n=28) were Smartphone users
prior to the intervention and 70% (n=21) owned a Smartphone. None of the
caregivers had difficulties in operating the Smartphone and accessing the
intervention. They generally supported the stroke survivors to access the
intervention and directed them to watch interrelated videos. Age, possession of a
Smartphone and previous experience using a Smartphone warranted the inclusion of
caregiver-support as an important aspect of the intervention.
Technical/Operational Issues encountered by the participants during field-testing:
Operational issues encountered by participants included
1. Poor connectivity inside the home.
2. Video streaming delay due to low 3G data allowance.
3. Low audio levels (e.g. participant resided in noisy areas).
4. English Version of the intervention not understandable, and Tamil version
needed.
5. Sliding interface Function of the application did not work well.
6. Clarity of the Pictures inadequate.
In addition, five stroke survivors (16.6%) and fifteen caregivers (50%) expressed that
they required more in-depth training and an operational manual to adequately learn
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and access the intervention from the Smartphone.
Revision and finalization of the intervention:
The above mentioned findings from the field-testing were shared with an expert
group consisting of professionals from various rehabilitation disciplines experienced
in stroke rehabilitation. After receiving their feedback and advice, the preliminary
field-tested version of the ‘Care for stroke’ Intervention was revised. The revised
intervention was once again shared with these expert group members for their
review and approval for finalisation. After approval from the expert panel, the
intervention was finalized. The finalized version of the intervention was then used
for pilot-testing.
Results of the Pilot-testing:
The demographic and clinical characteristics of the stroke survivors and their
caregivers are described in Table 2 and 3 respectively.
Feasibility for recruitment:
Study recruitment took place from December 2014 – February 2015. We identified 46
stroke survivors from the hospital records, of whom 30 were recruited (cause of
exclusion: death – 2; lack of contact details – 2; ineligible – 4; resided far from
hospital – 4; refusal – 4).
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Feasibility for training and utilisation:
Nearly 80% (n=24) of the stroke survivors required support from their caregivers to
use the intervention, 13.3% (n=4) expressed that they could manage by themselves
and 3.3% (n=1) required additional training to access the intervention. In contrast,
76.6% (n=23) of the caregivers managed the application themselves, 13.3% ((n=4)
required support from other caregivers at home and 6.6% (n=2) required further
training. Details of the training needs and pattern of utilization by study participants
are provided in table – 4.
Smartphone utilisation among study participants:
90% (n=27) of the stroke survivors had a Smartphone at home and over 40% (n=12) of
them had either mobile or broad-band internet connection at their home prior to the
intervention. Around 23.3% (n=7) of the stroke survivors owned a Smartphone
themselves. Around 70% (n=21) of primary caregivers owned a Smartphone and
about 60% (n=18) of these used all the features of their Smartphone. One family
member was available at a minimum for each stroke survivor with thorough
knowledge and experience of using a Smartphone and to support the stroke survivor
to use the intervention.
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Relevance of the Intervention:
All participants reported that the videos were very relevant to their rehabilitation
needs following stroke. Over 96.6% (n=29) of the stroke survivors felt that the
intervention was most relevant to their current rehabilitation needs. More than 76.6%
(n=23) of carers expressed that the intervention was definitely relevant to the needs
of the stroke survivors.
Although 50% (n=15) of the stroke survivors included in the study were functionally
independent, they still found the intervention relevant to them. All the participants
found the “information about stroke” section very relevant, especially in terms of
gaining awareness about the warning signs of stroke; and knowledge about stroke,
its impact and various aspects of recovery (Table – 4). The caregivers expressed that
they gained confidence and motivation to support the stroke survivor in their family
after watching the videos.
Comprehensibility of the intervention
When the study participants were asked about the overall comprehensibility of the
intervention, nearly 63.3% (n=19) of stroke survivors and over 76.6% (n=23) of carers
felt that the intervention was easily comprehensible. Participants reported that this
was especially because of the people who acted in the videos and the language in
which the audio descriptions were presented.
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The stroke survivors and caregivers expressed that they understood various sections
of the intervention through the photographs in the application alone. None reported
problems in either understanding the videos or the corresponding voice overs.
Participants expressed that high definition videos and simple language helped them
comprehend the intervention at ease.
Stroke survivors expressed enjoyment from learning about the Do’s and Don’ts after
stroke and the ways to manage daily living. They explained that they understood the
recovery process and the ways to prevent another stroke after watching the
intervention videos.
One stroke survivor explained:
“I was so depressed because of this problem. I did not know whether this could come back like
heart attack. Watching the videos about risk factors was such a relief. Now I understood that,
if I control my sugar and have a proper balanced diet, I can be away from another stroke”
User-Friendliness of the Smartphone-enabled intervention:
The Intervention was loaded onto a Micromax Canvas A102 Doodle3 Smartphone.
This Smartphone had configurations appropriate for accessing the intervention with
good connectivity, streaming speed and picture clarity, and was relatively cheap.
Other key aspects of user-friendliness of the intervention included
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1. Light weight of the Smartphone (584 gm).
2. Wide screen of the Smartphone (7”)
3. Video/Picture Quality and detailing (High Definition)
4. Streaming Speed (On Demand - Content Delivery Network [CDN])
5. Application Design and Access features (based on the needs felt by the stroke
survivors)
A stroke survivor expressed:
“It’s good that this is in a video format – It would be very difficult for me to read or
understand formal Tamil dialects with the problems in my eyes. I always like to watch TV
and hence I quite like the idea of teaching us ‘what to do’ through videos. Compared to
reading from a book, this is not so boring as well”
Usefulness of the intervention videos:
60% (n=18) of stroke survivors and 50% (n=15) of carers reported that the
intervention was very useful to them. The overall rating that the participants
provided for the usefulness of the intervention is presented in Table -4. Stroke
survivors explained that the video format of the intervention was very motivating.
They felt that the intervention provided very useful information about their problem,
the causes for their stroke and the ways to manage their recovery independently. A
stroke survivor who was unable to transfer or walk without support said:
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“I can now move from my bed to chair with some support from my sister. I am very happy to
have achieved this. I saw the videos on ‘how to move from one place to another with support’
and I practiced it with my sister. Thank you for helping me with your videos. I am planning
to learn more from it “
Over 96% (n=29) of stroke survivors felt that the intervention videos were self-
explanatory. The carers explained that the stroke survivors were able to accept the
importance of engaging in their daily living tasks and becoming as independent as
possible in their lives.
Acceptability of the Intervention
Two key features of the intervention that were most strongly valued by the majority
of study participants were
1. The Tamil audio descriptions of the intervention (local language)
2. The content of the intervention, especially the exercises and daily living task
sections, explained through demonstration by individuals, who resembled
stroke patients from Tamilnadu.
A stroke survivor described:
“I didn’t know that something like this is available in Chennai, I thought all these were in
foreign countries. My son showed me some videos where doctors are speaking in English and
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I could not understand much. But I was able to understand many things from these videos on
the phone – it was in Tamil so it was very easy”
Stroke survivors expressed that they were motivated and encouraged to see the
actual performance of daily living tasks using one-handed techniques by someone
like them in the videos.
A stroke survivor described:
“I am surprised that a person with stroke can do things by himself with the strong hand. It’s
eye opening. I felt, why I can’t try. I am now trying some of the tasks that I saw from the
videos, especially to use my hand to eat and dress myself.”
Acceptability of the Smartphone-enabled Application:
Stroke survivors found the portability of the intervention very useful for them, as
they were able to comfortably watch the intervention videos anywhere they wanted.
Stroke survivors also expressed that portability was very helpful in allowing them to
watch the intervention privately (at home or elsewhere) without disturbing others
and without feeling shy about the discreet content.
“It’s a big family – we are nine people in a single home and one TV for all of us. The TV room
will be busy all the time with lots of family members. This was one important reason why I
prefer the Smartphone instead of a DVD. I take this to any room or even my workplace and
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watch, it’s convenient to carry and comfortable to watch – no one knows what I am watching.
Otherwise people will feel pity about my situation”
Caregivers expressed that the Smartphone required very minimal physical effort in
terms of carrying or operating it.
A caregiver explained:
“To get up from your place, go near TV to switch on, find the remote, give connections etc. It
requires lots of work. I have to walk, bend and lift. I can’t do all this with my own problems –
this arthritis. This Smartphone that you gave is a nice choice. Nothing other than movement
of fingers to touch the screen is required. My wife watched it even when she was in bed
sometimes.”
Caregivers also appreciated the size of the Smartphone screen, which was big
enough to watch the videos comfortably without straining the eyes. They expressed
that they were able to access the intervention from their own Smartphone.
Caregivers found the repeatability of the intervention through simple touch and
slide options very comfortable, especially in supporting stroke survivors to
remember important information from the intervention and to reinforce the
importance of recovery. Caregivers also appreciated the design of the application
and the ability to share the intervention videos with others globally.
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A caregiver said:
“My daughter, who lives in Singapore, wanted to know what this phone thing is all about. So
we shared the details with her and asked her to watch it. Next day she called us and enquired
whether we are watching it or not and she calls every day to find out what we watched.”
Overall Likeableness of the intervention
When the study participants were asked about the likeableness of the intervention,
more than 56.6% (n=17) of stroke survivors and about 90% (n=27) of their carers
expressed that the intervention was definitely likeable. About 40% (n=12) of the
stroke survivors and 10% (n=3) of the carers felt that the intervention was likeable to
a great extent (Table – 4).
Overall rating for the Intervention:
More than 50% (n=15) of the stroke survivors and 63.3% (n=19) of the carers rated
‘Care for Stroke’ as excellent. The remaining proportion of participants rated the
intervention as very useful (Table -4).
Suggestions by participants:
A major concern voiced by several participants (n=6) was internet connectivity, since
intervention videos were streamed online through the web-based application service.
These six participants were living in remote locations (outskirts of the city) with very
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poor connectivity. Participants with a broad band internet connection did not report
any concerns about connectivity and online streaming issues. Two participants
(6.6%) felt that the intervention could have been provided for longer, whilst several
others reported that the intervention should have been provided when they were
first hospitalised for stroke. Five participants (n=16.6%) requested a follow-up home
visit by a member of the hospital team to reassess their recovery following stroke.
Seven participants (n=23.3%) suggested that this intervention should be provided to
every stroke survivor in every hospital and also to the public to prevent further
strokes and its recurrence.
Clinical Outcomes:
Results from the analysis of clinical outcomes showed statistically significant
improvement in the scores of Barthel Index and MRS between before and after the
intervention period (Table - 5).
Discussion:
The evaluation revealed that there was a minimum of one Smartphone user and one
Smartphone in every participant’s family. This indicates the availability and degree
of Smartphone penetration in a city like Chennai, which makes it potentially feasible
for the Smartphone-enabled carer-supported ‘Care for Stroke’ intervention to be
widely used for provision of rehabilitation services in the future. The intervention
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was also found to be highly relevant, easily comprehensible, substantially useful,
largely likeable and satisfying to a greater extent. This implies the level of
acceptability of the intervention among the study participants. Given the lack of
availability and accessibility of this kind of informational or educational intervention
in India, ‘Care for Stroke’ was highly acceptable among its users.
Having experienced stroke for the first time and very recently, stroke survivors were
unable to accept the disabling effects of stroke. They felt that they would recover
with medications gradually, rather than with any rehabilitation intervention. Hence,
over 50% (n=17) of the stroke survivors were confident only to some extent in using
the intervention. This in turn is likely to have led to the 20% (n=6) of stroke survivors
and 25% (n=8) of primary carers using the intervention only occasionally, and for the
two stroke survivors who reported that the intervention was useful only to some
extent. However these stroke survivors were supported by their caregivers. The
primary caregivers were who had difficulty in using this intervention was in turn
supported by other members in the family.
Although the results from assessment of clinical outcomes were statistically
significant, the amount of clinical gains obtained by the stroke survivors during the
intervention period was relatively small (17), and not necessarily attributable to the
intervention. Given the clinical significance and the small sample-size in the pilot-
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testing, the statistical results obtained from the outcome measures have to be
carefully interpreted (18). However, the objective of using these clinical outcome
measures was to look at their feasibility for use in future trials of the intervention.
Despite a short intervention period (4 weeks), these clinical outcome measures were
able to detect statistically significant difference, thus establishing their feasibility for
use in future clinical trials and effectiveness evaluations of the ‘Care for Stroke’
intervention.
Field-testing of the intervention facilitated the investigators to address key
operational uncertainties that could have affected feasibility and acceptability. It also
provided an opportunity to review, and revise the intervention before it was pilot-
tested. Pilot-testing of the intervention prior to its effectiveness evaluation assisted
investigators to understand the factors that could affect feasibility and acceptability
of the intervention. It provided valuable information that could be used to plan and
organize rigorous effectiveness evaluation of the intervention in the future. A phased
approach to the development of the intervention facilitated provision of proper
consideration to the practical aspects of evaluation, providing assurance that the
intervention could be delivered as intended in the future (19).
Accommodating multiple centres from the same geographical location for
recruitment of participants for future studies could hasten the process of participant
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recruitment and thereby the evaluation process. Future studies could broaden the
criteria for participant inclusion to more easily achieve the desired sample size and
also to stratify the effects of the intervention by different sub-groups of stroke
survivors.
Conclusion:
Evaluation of the ‘Care for stroke’ Intervention establishes its feasibility in an Indian
context and acceptability among the study stroke survivors and their caregivers. This
makes it possible for the investigators to affirm that provision of a Smartphone-
enabled, carer-supported educational intervention for management of post-stroke
disabilities could be a potential strategy to meet the growing need for stroke
rehabilitation services in settings were rehabilitation resources are very limited.
Adoption and modification of the ‘Care for Stroke’ intervention, with due
importance to the cultural aspects of the target population, could potentially aid in
bridging the gaps in access to stroke rehabilitation services not just in India but also
in other low-resourced countries where the rehabilitation needs of stroke survivors
are substantial.
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References:
1. Mackay J, Mensah G. The Atlas of heart disease and stroke. World Health
Organization. Geneva, Switzerland. WHO. 2004. Available at:
http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.
pdf: The Atlas of Heart Disease and Stroke. (accessed on 5 April 2011)
2. Disability and rehabilitation action plan 2006-2011: World Health Organization
Geneva, Switzerland. WHO. 2005. Available at:
http://www.who.int/disabilities/publications/dar_action_plan_2006to2011.pdf
(accessed on 9 June 2015)
3. World report on disability. World Health Organization. Geneva, Switzerland.
WHO. 2011. Available at
http://www.who.int/disabilities/world_report/2011/report/en/ (accessed on 5
April 2015).
4. Ferri CP, SChoenborn C, Kaira L, et al. Prevalence of stroke and related
burden among older people living in Latin America, India and China. J Neurol
Neurosurg Psychiatry. 2011; 82:1074-1082.
5. Peter Craig, Mark Petticrew, Developing and evaluating complex
interventions: Reflections on the 2008 MRC guidance. International Journal of
Nursing Studies. 2013; 50 (5): 585-587.
6. Craig P. Foreword. In: Richards D, Rahm Hallberg I. Complex interventions in
health: an overview of research methods. Routledge, 2015.
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7. K Sureshkumar, GVS Murthy, Sanjay Kinra, Shifalika Goenka, Hannah Kuper.
Development and evaluation of a smartphone-enabled carer-supported
educational intervention for management of disabilities following stroke in
India – Protocol for the research study. BMJ Innovations. 2015; 1: 117-126.
8. Craig P, Cooper C, Gunnell D, Haw S, Lawson K, et al. Using natural
experiments to evaluate population health interventions: new Medical
Research Council guidance. Journal of Epidemiology & Community Health. 2012;
66:1182-1186
9. WHO MONICA Project Investigators. The World Health Organization
MONICA Project (Monitoring trends and determinants in cardiovascular
disease). J Clin Epidemiol 1988; (41): 105-114.
10. Department of Health and Human Services. NIH Stroke Scale Training, Part 2.
Basic Instruction. The National Institute of Neurological Disorders and Stroke
(NINDS), 2010.
11. Ver Hage. The NIH stroke scale: a window into neurological status.
Nursing Spectrum (Greater Chicago). 2011; 24 (15):44-49.
12. Mahoney F. Barthel D. Functional evaluation: the Barthel Index. Md. Med
J.1965; 14: 61–65.
13. Cumming TB, Blomstrand C, Bernhardt J, et al. The NIH stroke scale can
establish cognitive function after stroke. Cerebrovasc Dis. 2010; 30 (1):7-14.
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14. Sureshkumar K,Murthy GVS, Munuswamy S, S. Goenka and H Kuper. ‘Care
for Stroke’ a web-based, Smartphone-enabled educational intervention for
management of physical disabilities following stroke: Feasibility in the Indian
context. BMJ Innovations 2015; 1 127–136.
15. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework
method for the analysis of qualitative data in multi-disciplinary health
research. BMC Medical Research Methodology. 2013; 13:117. Doi: 10.1186/1471-
2288-13-117.
16. Van Swieten JC, Koudstaal PJ, Visser MC, et al. Interobserver agreement for
the assessment of handicap in stroke patients. Stroke. 1988; 19: 604–607.
17. Sedgwick Philip. Clinical significance versus statistical significance BMJ 2014;
348: g2130.
18. Sedgwick Philip. The importance of statistical power BMJ 2013; 347: f6282.
19. Moore Graham, F Audrey Suzanne, Barker Mary, Bond Lyndal, Bonell Chris
et al. Process evaluation of complex interventions: Medical research council
guidance BMJ 2015; 350: h1258.
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Funding
This work was supported by a Wellcome Trust Capacity Strengthening Strategic
Award to the Public Health Foundation of India and a consortium of UK
universities.
Ethics approval:
Ethics approval for this research study was obtained from Ethics approval London
School of hygiene and Tropical Medicine, VHS Hospital and Public health
Foundation of India.
Competing Interests
The authors declare that they have no competing interests, financial or non-financial.
Authors’ Contributions
Suresh Kumar. K (SK) conceived, designed and drafted the manuscript. Prof GVS
Murthy and Dr Hannah Kuper played a crucial role in conception of the research
study and provided substantial guidance in designing and conducting the
evaluation. Dr Shifalika Goenka and Dr Subbulakshmy N provided advice related to
conception and actual conduct of the evaluation. Naveen C assisted in carrying out
the quantitative analysis.
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Acknowledgement
We thank Wellcome-trust and Public Health Foundation of India for funding the
research study and also the student to undertake the research study as a part of his
doctoral study at the London School of Hygiene and Tropical Medicine. We thank
the ethics committee of the London School of Hygiene and Tropical Medicine, PHFI-
Indian Institute of Public Health - Hyderabad and The Voluntary Health Services
Hospital for granting scientific and ethical approval to conduct this research study.
We thank the members of the expert committee who provided valuable advice on
the development and evaluation of the intervention. We thank colleagues from TINS
VHS who patiently assisted in conducting the evaluation. We also thank consultants
from Suchir softech and Selva photography for revising the application and digitized
content during the evaluation.
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Tables Table: 1 Demographic and Clinical Characteristics of the stroke survivors and caregivers (Field-
testing)
Characteristics
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender: 20 (67%) 10 (33%) 30 (100%)
Age: Mean (SD) 51.3 (14.6) 60 (13.6) 54.2 (14.7)
Education:
Primary school or higher 18 (90%) 8 (80%) 24 (80%)
Marital status 18 (90%) 9 (90%) 27 (90%)
Working prior to stroke: 20 (100%) 6 (60%) 26 (87%)
Currently working: 10 (50%) 5 (50%) 15 (50%)
First ever stroke: 20 (100%) 10 (100%) 30 (100%)
Stroke type:
Ischaemic: 18(90%) 9(90%) 27 (90%)
Haemorrhagic: 2 (10%) 1 (10%) 3 (10%)
Stroke severity:
Minor: 9 (45%) 3 (30%) 12 (40%)
Moderate: 11 (55%) 7 (70%) 18 (60%)
Affected side:
Right 12 (60%) 6 (60%) 18 (60%)
Left 8 (40%) 4 (40%) 12 (40%)
Level of dependence:
Independent: 11 (55%) 4 (40%) 15 (50%)
One Person Assistance: 9 (45)% 6 (60%) 15 (50%)
Receiving Physiotherapy 6 (30%) 2 (20%) 8 (27%)
Smartphone users 8 (40%) 3 (30%) 11 (37)%
Use of Assistive aids: 4 (20%) 5 (50%) 9 (30%)
Demographic Characteristics of the Caregivers
Characteristics Male Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender: 15 (50%) 15 (50%) 30 (100%)
Age: Mean (SD) 34.6 (±6.7) 28.6 (±7.5) 31.63 (±7.66)
Education Primary school or higher 15 (100%) 15 (100%) 30 (100%)
Employed: 14 (93%) 7 (47%) 21 (70%)
Primary caregivers: 9 (60%) 7 (47%) 16 (53%)
Own a Smartphone: 12 (80%) 9 (60%) 21 (70%)
Smartphone users 14 (93%) 13 (87%) 28 (93)%
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Table: 2 Demographic and Clinical Characteristics of the stroke survivors (Pilot-testing)
Characteristics
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender: 18 (60%) 12 (40%) 30 (100%)
Age: Mean (SD) years 58 (±12.8)
years 57.8 (±8.8) years 57.9 (±11.27) years
Education:
Primary school or higher 17 (94 %) 9 (75%) 26 (87%)
Currently married 18 (100%) 12 (100%) 30 (100%)
Working prior to stroke: 13 (72%) 3 (25%) 16 (53%)
Currently working: 2 (11%) 1 (8%) 3 (10%)
Unable to return to their usual
roles/routines: 11 (61%) 11 (92%) 22 (73%)
First ever stroke: 18 (100%) 12 (100%) 30 (100%)
Stroke type:
Ischaemic: 13(72%) 11 (92%) 24 (80%)
Haemorrhagic: 5 (28%) 1 (8%) 6 (20%)
Stroke severity:
Minor: 4 (22%) 4 (33%) 8 (27%)
Moderate: 14 (78%) 8 (67%) 22 (73%)
Affected side:
Right 10 (55%) 8 (67%) 18 (60%)
Left 7 (39%) 4 (33%) 11 (37%)
Both 1 (6%) 0 (0%) 1 (3%)
Involvement of Hand 15 (83%) 11 (92%) 26 (87%)
Level of dependence:
Independent-personal care 4 (22%) 3 (25%) 7 (23%)
One Person assistance needed 14 (78%) 9 (75%) 23 (77%)
Receiving Physiotherapy Services 4 (22%) 4 (33%) 8 (27%)
Using Mobility aids 2 (11%) 4 (33%) 6 (20%)
Own Smartphone 5 (28%) 2 (17%) 7 (23)%
Use Smartphone regularly 3 (17%) 0 (0%) 3 (10)%
Have Mobile Internet Connection 7 (39%) 6 (50%) 13 (43%)
Have Smartphone at home 15 (83%) 11 (92%) 26 (87%)
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Table: 3 Demographic Characteristics of the Caregivers (Pilot-testing)
Characteristics
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender 11 (37%) 19 (63%) 30 (100%)
Age: Mean (SD) years 39.4 (±14) years 39.5 (±14) years 39.5 (±13.7) years
Education:
Primary school or higher 11 (100%) 18 (95%) 29 (97%)
Currently married 7 (64%) 15 (79%) 22 (73%)
Working/Studying 9 (82%) 18 (95%) 27 (90%)
Primary caregivers 7 (64%) 18 (95%) 25 (83%)
Own a Smartphone 9 (82%) 12 (63%) 21 (70%)
Smartphone users 7 (64%) 11 (58%) 18 (60%)
Other caregivers of the stroke
survivors at home:
Male
Participants
N (%)
Female
Participants
N (%)
All
Participants
N (%)
Gender 16 (53%) 14 (47%) 30 (100%)
Age: Mean (SD) years 30.6 (±8.6) years 26 (±6.6) years 28.5 (±7.9) years
Smartphone users: 16 (100%) 14 (100%) 30 (100%)
Smartphone owners: 14 (87%) 10 (71%) 24 (80%)
Table - 4: Details of participant responses from the satisfaction survey (Pilot-testing)
Participants Initial impression about the intervention
Interesting
N (%)
Encouraging
N (%)
Motivating
N (%)
Consoling
N (%)
All
N (%)
None
N (%)
Stroke
survivors 7 (23.3%) 3 (10%) 1 (3.3%) 17 (56.7%)
2
(6.7%) 0 (0%)
Caregivers 9 (30%) 6 (20%) 10 (33.3%) 4 (13.3%) 1
(3.3%) 0 (0%)
Need for training and support to access the intervention
Need Support
from others
N (%)
Can Manage
Myself
N (%)
Need
Training
N (%)
Need Training and
support from others
N (%)
Not sure
N (%)
Stroke
survivors 24 (80%) 4 (13.3%) 1 (3.3%) 0 (0%) 1 (3.3%)
Caregivers 4 (13.3%) 23 (76.7%) 2 (6.7%) 0 (0%) 1 (3.3%)
Overall Confidence to use the Intervention
Definitely
Confident
N (%)
Confident to
a greater extent
N (%)
Confident to
some extent
N (%)
Confident to
a small extent
N (%)
Not confident
N (%)
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Stroke
survivors 3 (10%) 9 (30%) 17 (56.7%) 1 (3.3%) 0 (0%)
Caregivers 17 (56.7%) 12 (40%) 1 (3.3%) 0 (0%) 0 (0%)
Utilisation pattern of the intervention – The intervention was used
More than
once weekly
N (%)
Whenever
possible
N (%)
More than
once daily
N (%)
whenever
necessary
N (%)
Did not use
N (%)
Stroke
survivors 15 (50%) 14 (46.7%) 1 (3.3%) 0 (0%) 0 (0%)
Caregivers 14 (46.7%) 9 (30%) 2 (6.7%) 5 (16.7%) 0 (0%)
Practicing the skills learnt from the intervention
Practice
Always
N (%)
Practice
Frequently
N (%)
Practice
Occasionally
N (%)
Practice
Rarely
N (%)
Never
Practice
N (%)
Stroke
survivors 7 (23.3%) 16 (53.3%) 6 (20%) 1 (3.3%)
0 (0%)
Caregivers 7 (23.3%) 15 (50%) 8 (26.7%) 0 (0%) 0 (0%)
Overall Usefulness of the intervention
Definitely
Useful
N (%)
Useful to a
great extent
N (%)
Useful to
some extent
N (%)
Useful to a
small extent
N (%)
Not
useful
N (%)
Stroke
survivors 19 (63.3%) 9 (30%) 2 (6.7%) 0 (0%) 0 (0%)
Caregivers 9 (30%) 20 (66.7%) 1 (3.3%) 0 (0%) 0 (0%)
Overall likeableness of the intervention
Yes Definitely
N (%)
Yes to a Great extent
N (%)
Yes to Some extent
N (%)
Stroke
survivors 17 (56.7%) 12 (40%) 1 (3.3%)
Caregivers 27 (90%) 3 (10%) 0 (0%)
Overall Rating for the Smartphone-enabled Intervention
Excellent
N (%)
Very Useful
N (%)
Satisfactory
N (%)
Stroke
survivors 16 (53.3%) 13 (43.3%) 1 (3.3%)
Caregivers 20 (66.7%) 10 (33.3%) 0 (0%)
Overall Rating for the usefulness of the Intervention
Very Useful
N (%)
Extremely useful
N (%)
Useful to an extent
N (%)
Stroke
survivors 17 (56.7%) 11 (36.7%) 2 (6.7%)
Caregivers 14 (46.7%) 16 (53.3%) 0 (0%)
Interesting sections of the intervention for the participants
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All Sections
N (%)
Stroke
Information
Section
N (%)
Stroke
Information
and exercises
Sections
N (%)
Stroke
Information
and ADL
Sections
N (%)
Stroke
Information
and
Functional
skills
sections
N (%)
Exercises
section
N (%)
Stroke
survivors 12 (40%) 7 (23.3%) 5 (16.7%) 4 (13.3%) 1 (3.3%) 1 (3.3%)
Caregivers 17 (56.7%) 5 (16.7%) 4 (13.3%) 2 (6.7%) 0 (0%) 2 (6.7%)
ADL – Activities of Daily Living
Table - 5: Details from the analysis of the outcome measures (Pilot-testing)
Outcomes
Pre-
Intervention
(Baseline)
Post-
intervention
(End point)
Mean Difference with
95% CI
Test for overall
effect
Barthel Index
Mean (SD) 57.8 (± 26.6) 70 (± 25.8)
-12.16
(-15.3, -9.00)
-7.86
P < 0.00001**
Modified Rankin Scale
Mean (SD) 3.2 (± 0.8) 2.7 (± 1.1)
0.53
(0.34, 0.72)
5.75
P < 0.00001**
**p < 0.05 significant difference in group
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Evaluation of the feasibility and acceptability of the ‘Care for stroke’ intervention in India: A Smartphone-enabled
Carer-supported Educational intervention for management of disability following stroke.
Journal: BMJ Open
Manuscript ID bmjopen-2015-009243.R2
Article Type: Research
Date Submitted by the Author: 19-Nov-2015
Complete List of Authors: K, Sureshkumar; Public Health Foundation of India, SACDIR; London School of Hygiene and Tropical Medicine, International Center for Evidence in Disability Gudlavalleti, Murthy; London School of Hygiene & Tropical Medicine, CRD Natarajan, Subbulakshmy; VHS Hospital, T.S Srinivasan Institute of Neurological Sciences C, Naveen; Indian Institute of Public Health - Hyderabad, Biostatistics Goenka, Shifalika; Indian Institute of Public Health Delhi, Public Health Kuper, Hannah; The London School of Hygiene & Tropical Medicine, Clinical Research
<b>Primary Subject Heading</b>:
Public health
Secondary Subject Heading: Rehabilitation medicine, Research methods, Health services research, Geriatric medicine, Global health
Keywords:
World Wide Web technology < BIOTECHNOLOGY & BIOINFORMATICS, PUBLIC HEALTH, Stroke < NEUROLOGY, REHABILITATION MEDICINE, GERIATRIC MEDICINE, Health informatics < BIOTECHNOLOGY & BIOINFORMATICS
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Evaluation of the feasibility and acceptability of the ‘Care for stroke’ intervention in India: A
Smartphone-enabled, Carer-supported, Educational intervention for management of disability
following stroke.
K Sureshkumar1, GVS Murthy2, N Subbulakshmy 3, C Naveen4, Shifalika Goenka 5 Hannah
Kuper 6
Corresponding Author:
Sureshkumar Kamalakannan
Department of Clinical Research,
Faculty of Infectious & Tropical Diseases,
London School of Hygiene and Tropical Medicine,
Keppel Street, London,
WC1E 7HT.
Email: [email protected]
Phone: +91 9840772381, +91 9676333412
Authors
1. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected] Phone: +91 9840772381,
+91 9676333412
2. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected]
3. T.S Srinivasan Institute of neurological Sciences, VHS Hospital, Rajiv Gandhi Salai,
Taramani Chennai, 600113. [email protected]
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4. Indian institute of Public Health (Pubic Health Foundation of India) Hyderabad, Plot
1 ANV Arcade, Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad,
Telangana, 500033. [email protected]
5. Indian Institute of Public Health (Public Health Foundation of India), Delhi, Plot no.
34, Sector-44, Institutional Area, Gurgaon-122002, Haryana, India.
6. International centre for Evidence in Disability, Department of Clinical Research,
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E
7HT. [email protected]
Keywords
1. Disability
2. Feasibility
3. Mhealth
4. Rehabilitation
5. Stroke
6. Smartphone
Word Count: Manuscript: - 4218
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Abstract:
Objectives
1. Identify operational issues encountered by the study participants in using the
‘Care for stroke’ intervention.
2. Evaluate the feasibility and acceptability of the intervention.
Design: Mixed-methods research design
Setting: The study took place in participant’s home. Participants were selected from
a tertiary hospital in Chennai, South-India.
Participants: Sixty stroke survivors treated and discharged from the Hospital and
their caregivers.
Intervention: ‘Care for stroke’ is a smartphone-enabled, educational intervention for
management of physical disabilities following stroke. It is delivered through a web-
based, Smartphone-enabled application. It includes inputs from stroke rehabilitation
experts in a digitized format.
Methods: Evaluation of the intervention was completed in two phases. In the first
phase, the preliminary intervention was field-tested with 30 stroke survivors for two
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weeks. In the second phase, the finalized intervention was provided to a further 30
stroke survivors to be used in their homes with support from their carers for four
weeks.
Primary and secondary outcome measures:
The primary outcomes were
1. Operational difficulties in using the intervention.
2. Feasibility and acceptability of the intervention in an Indian setting.
Disability and dependency were assessed as secondary outcomes.
Results: The field-testing identified operational difficulties related to connectivity,
video-streaming, picture-clarity, quality of videos and functionality of the
application. The intervention was reviewed, revised and finalized before pilot-
testing. Findings from the pilot-testing showed that the ‘care for stroke’ intervention
was feasible and acceptable. Over 90% (n=27) of the study participants felt that the
intervention was relevant, comprehensible and useful. Over 96% (n=29) of the stroke
survivors and all the caregivers (100%, n=30) rated the intervention as excellent and
very useful. These findings were supported through the qualitative interviews.
Conclusion: Evaluation indicated that the ‘Care for stroke’ intervention was feasible
and acceptable in an Indian context. An assessment of effectiveness is now
warranted.
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Strengths and limitations of this study:
• A phased approach to the development and evaluation of the intervention
helped refine the intervention
• Mixed research methods was used for evaluation of the intervention
• Recruitment of participants from only one centre
• Stringent inclusion criteria for participant recruitment
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Background:
Each year, about 15 million people suffer stroke globally. One third of stroke
survivors experience permanent disability (1). Increased population aging and the
rising prevalence of risk factors for stroke will further increase the number of people
living with stroke-related disabilities (2). Projections by the World Health
Organization (WHO) show that the disability adjusted life years (DALYs) lost to
stroke will rise from 38 million in 1990 to 61 million by 2020 (1). These projections
imply an overwhelming global demand for stroke rehabilitation services (3). This is
especially true in low and middle income countries (LMICs) which bears a
substantial amount of the global burden of stroke (4) yet has few rehabilitation
services available.
The high burden of stroke but lack of rehabilitation services creates the need for
developing and evaluating innovative strategies such as the use of mobile phones or
smartphone-based applications for provision of health-care services (5). These mobile
health (Mhealth) strategies capitalise on the core functionalities of a mobile or
Smartphone and are strongly recommended by the WHO for bridging the gaps in
accessibility to health services globally (6). This was the rationale for developing ‘Care
for stroke’, which is a web-based, Smartphone-enabled, caregiver-supported,
educational intervention for management of physical disabilities following stroke.
This Mhealth intervention draws on the principles of both medical sciences and
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information technology to address the gaps in access to stroke rehabilitation services
for stroke survivors in a systematic way, as recommended by the Medical Research
Council (MRC) (7-8). The intervention has been developed with a specific focus on
LMICs where the resources available for rehabilitation are often very limited. To our
knowledge, there are no stroke rehabilitation interventions enabled through Mhealth
platforms that are available and relevant to the context of LMICs, such as India,
where the resources for rehabilitation are limited and the unmet needs of stroke
survivors are substantial (9). Therefore, it was decided to evaluate this newly
developed rehabilitation intervention in an Indian context.
The research study protocol is available elsewhere which describes the participatory
development of the intervention (10). This paper describes the field-testing and pilot-
testing of the intervention. The purpose of field-testing was to provide the newly
developed intervention to stroke survivors and their caregivers and assess any
initial operational difficulties experienced. This enabled revision and refinement of
the intervention before it was tested for feasibility and acceptability (pilot-testing).
Primary objectives of the evaluation:
1. Identify operational issues encountered by the study participants through
field-testing.
2. Revise the intervention based on the findings from the field-testing.
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3. Evaluate the feasibility and acceptability of the intervention among the
stroke survivors and their caregivers through pilot-testing.
Methods:
Mixed Methods Research Design:
This study applied mixed research methods, in order to collect more
comprehensive evidence regarding the research question. The mixed-methods
approach was specifically chosen because it is known to encourage the use of
multiple worldviews and is a pragmatic approach to research pertaining to
development of complex interventions (11).
Participant selection and recruitment
Only one hospital (T.S Srinivasan Institute of Neurological Sciences, VHS Multi-
specialty hospital in Chennai) provided permission to recruit participants. The
newly developed ‘Care for stroke’ intervention was evaluated with a sample of 60
adult stroke survivors and their caregivers living in Chennai, South India (30 pairs
of stroke survivors and their caregivers for field-testing and 30 pairs for pilot-testing).
All were previously treated for their stroke at VHS hospital, which has an admission
rate of three – four stroke patients per week. Given the hospital admission rate and
the time that was available within the PhD. We were able to recruit only 30 pairs of
participants for field-testing and 30 pairs for pilot-testing.
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Study participants were purposively selected from the hospital records and invited
to the hospital for follow-up. Contact details of participants were retrieved from their
hospital records. During the follow-up consultation, the stroke survivor was
assessed for their eligibility to participate in the study by a neurologist. If the
participant was determined to be eligible, they were provided with detailed
background about the study and its purpose by the investigator (SK). Informed
written consent was obtained from those who agreed to participate in the study.
The inclusion criteria were
• Adults (aged ≥18 years)
• Recent diagnosis of first ever stroke (FES) as defined by the WHO (12)
within 3-6 weeks prior to the recruitment.
• Severity of stroke: minor and moderate (score 1-15, according to the NIH
stroke scale (13-14)).
• Stroke survivor medically stable (reaching a point in medical treatment
where life-threatening problems following stroke have been brought under
control)
• Post-stroke functional status of the stroke survivor: Requiring assistance of
at least one person to perform daily activities such as transfers, self- care and
mobility (scoring less than the maximum score obtainable in one or more
components of the Barthel Index (15))
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• Stroke survivor residing with a primary caregiver (family member) at home
Further exclusion criteria were:
• Participants with NIH score > 15
• Severe cognitive difficulties (Scoring >1 in Orientation, Executive function,
Inattention and Language components of the NIH stroke scale components for
cognition) (16)
• Severe communication problem (Scoring >1 in Dysarthria and Best Language
component of the NIH stroke scale (13-14))
• Severe co-morbidities (severe psychiatric illness, hearing loss, vision loss)
• Stroke survivor - functionally dependent due to other pre-existing conditions
(e.g. amputation, fracture, dementia etc.)
• Stroke survivor without a primary caregiver
• Stroke survivor unwilling / unable to adhere to the study protocol
• Participants who did not meet the training requirements regarding
operation of a Smartphone
About the Intervention
The ‘Care for stroke’ intervention was delivered through a Smartphone and included
information about stroke and the ways to manage post-stroke disabilities. This was
provided through text and videos in the local Tamil language. The intervention is
web-based and hence requires an internet connection. It includes modules on
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information about stroke, home-based exercises, functional skills training, activities
of daily living and assistive devices. Further details about the intervention have been
described earlier (17) and as an online supplement (Supplementary file – 1).
Training and administration of the intervention
The educational intervention was pre-loaded onto the Smartphone. The stroke
survivor and their caregiver received 20-30 minutes training from the investigator
(SK) on access and use of the intervention via the Smartphone. Participants were
then provided with a Smartphone pre-loaded with ‘Care for stroke’ intervention (i.e.
a smartphone along with the intervention loaded onto it) and asked to try it out on
their own. Three or more errorless attempts to retrieve the required part of the
intervention from the Smartphone were considered successful training.
Participants were asked to use this intervention at home for two weeks during the
field-testing phase and for four weeks during the pilot-testing phase. The caregivers
of stroke survivors selected for this study were asked to support the stroke
survivors in accessing the intervention from the Smartphone as and when required.
Direct Observation and interviews during field-testing
Utilization of the Smartphone-enabled intervention and the support provided by the
caregivers to the stroke survivors was assessed by the investigator (SK). Direct
participant observation (with observation checklist) and short unstructured
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interviews related to the objectives of the field-testing were carried out at each
participant’s home during this phase. Key issues assessed included:
a. Relevance and comprehensibility
b. Operational difficulties and user-friendliness
c. T e c h n i c a l issues
d. Training needs
Assessment of feasibility and Acceptability during pilot-testing:
Feasibility and acceptability of the intervention was assessed primarily through a
semi-structured questionnaire administered to stroke survivors and primary care
givers. The majority of questions in the questionnaire were related to satisfaction
and patient experience. The questionnaire predominantly included closed-ended
questions with ordered (Likert-Scale) responses (Supplementary file – 2). The
frequency of each response was calculated separately for each question in the
questionnaire. The questionnaire schedule was developed, translated and pilot-
tested before it was administered. In addition to this, participants were also asked
specific open-ended questions related to the objectives of the pilot-testing.
Participants’ responses to the questions were transcribed verbatim and translated
into English. Transcribed data were then analysed using the Framework approach
(18).
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Assessment of clinical outcomes:
Independence in activities of daily living was assessed using the Barthel Index (BI) (15)
and disability was assessed using the Modified Rankin Scale (MRS) (19). The
investigator (SK) carried out this assessment to investigate the feasibility of using
these clinical outcome measures in a future larger trial of the intervention.
Analysis of clinical outcome measures:
Pre-intervention and Post-intervention scores for the Barthel Index and Modified
Rankin Scale were analysed using the paired, student T-test method.
Results of the field-testing:
The demographic and clinical characteristics of the stroke survivors and their
caregivers are described in Table 1.
Abilities of the participants to access the Intervention from a Smartphone:
Stroke survivors:
Among 30 stroke survivors selected for the field-testing, 37% (11 participants) used a
Smartphone prior to their stroke. During the field-testing, seven stroke survivors
(n=23%) (6 men and 1 woman) independently accessed the intervention through the
Smartphone. All remaining participants were supported by their caregivers to access
the intervention – especially in operating the Smartphone to access desired videos.
Three stroke survivors (10%) used headphones to listen to the audio while watching
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the videos. Stroke survivors preferred to use their affected hand to hold or stabilise
the Smartphone and operate it using their unaffected hand. Most often, stroke
survivors preferred to watch the video first, understand it and then practice the
techniques shown at a later point.
Caregivers:
Among the caregivers included in field-testing, 93% (n=28) were Smartphone users
prior to the intervention and 70% (n=21) owned a Smartphone. None of the
caregivers had difficulties in operating the Smartphone and accessing the
intervention. They generally supported the stroke survivors to access the
intervention and directed them to watch interrelated videos.
Technical/Operational Issues encountered by the participants during field-testing:
Operational issues encountered by participants included
1. Poor connectivity inside the home.
2. Video streaming delay due to low 3G data allowance.
3. Low audio levels (e.g. participant resided in noisy areas).
4. English Version of the intervention not understandable, and Tamil version
needed.
5. Inability to access various webpages of the intervention by sliding the
touchscreen on the Smartphones.
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6. Inadequate clarity of the pictures.
In addition, five stroke survivors (17%) and fifteen caregivers (50%) expressed that
they required more in-depth training and an operational manual to adequately learn
and access the intervention from the Smartphone.
Revision and finalization of the intervention:
The findings from the field-testing were shared with an expert group consisting of
professionals from various rehabilitation disciplines experienced in stroke
rehabilitation. After receiving their feedback and advice, the preliminary field-tested
version of the ‘Care for stroke’ intervention was revised. All the operational issues
identified during the field-testing (e.g. the connectivity issues, poor audio / video
quality, delayed video streaming, language issues, touching screen sliding
functionality) were rectified by the technical consultants. This revised version of the
intervention was once again shared with these expert group members for their
review and approval for finalisation. The finalized version of the intervention was
then used for pilot-testing.
Results of the Pilot-testing:
The demographic and clinical characteristics of the stroke survivors and their
caregivers are described in Table 1.
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Feasibility for recruitment:
Study recruitment took place from December 2014 – February 2015. We identified 46
stroke survivors from the hospital records, of whom 30 were recruited (cause of
exclusion: death – 2; lack of contact details – 2; ineligible – 4; resided far from
hospital – 4; refusal – 4).
Feasibility for training and utilisation:
Nearly 80% (n=24) of the stroke survivors required support from their caregivers to
use the intervention, 13% (n=4) expressed that they could manage by themselves and
3% (n=1) required additional training to access the intervention. In contrast, 77%
(n=23) of the caregivers managed the application themselves, 13% ((n=4) required
support from other caregivers at home and 7% (n=2) required further training.
Details of the training needs and pattern of utilization by study participants are
provided in table 2.
Smartphone utilisation among study participants:
90% (n=27) of the stroke survivors had a Smartphone at home and over 40% (n=12) of
them had either mobile or broad-band internet connection at their home prior to the
intervention. Only 23% (n=7) of the stroke survivors owned a Smartphone
themselves. 70% (n=21) of primary caregivers owned a Smartphone and about 60%
(n=18) of these used all the features of their Smartphone. One family member was
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available at a minimum for each stroke survivor with thorough knowledge and
experience of using a Smartphone and to support the stroke survivor to use the
intervention.
Relevance of the Intervention:
All participants reported that the intervention videos related to ‘the information
about stroke, activities of daily living and exercises were very relevant to their
rehabilitation needs following stroke. Almost all (97% - n=29) of the stroke survivors
felt that the intervention was most relevant to their current rehabilitation needs.
Majority of carers (77% - n=23) reported that the intervention was definitely relevant
to the needs of the stroke survivors.
Although 50% (n=15) of the stroke survivors included in the study were functionally
independent, they still found the intervention relevant to them. All the participants
found the “information about stroke” section very relevant, especially in terms of
gaining awareness about the warning signs of stroke; and knowledge about stroke,
its impact and various aspects of recovery (Table 2). The caregivers reported that
they gained confidence and motivation to support the stroke survivor in their family
after watching the videos.
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Comprehensibility of the intervention
When the study participants were asked about the overall comprehensibility of the
intervention, 63% (n=19) of stroke survivors and 77% (n=23) of carers felt that the
intervention was easily comprehensible. Participants attributed this to the people
who acted in the videos and the language in which the audio descriptions were
presented.
The stroke survivors and caregivers reported that they understood various sections
of the intervention through the photographs in the application alone. None reported
problems in either understanding the videos or the corresponding voice overs.
Participants stated that high definition videos and simple language helped them
comprehend the intervention at ease.
Stroke survivors reported enjoyment from learning about the Do’s and Don’ts after
stroke and the ways to manage daily living. They explained that they understood the
recovery process and the ways to prevent another stroke after watching the
intervention videos.
One stroke survivor explained:
“I was so depressed because of this problem. I did not know whether this could come back like
heart attack. Watching the videos about risk factors was such a relief. Now I understood that,
if I control my sugar and have a proper balanced diet, I can be away from another stroke”
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User-Friendliness of the Smartphone-enabled intervention:
The Intervention was loaded onto a Micromax Canvas A102 Doodle3 Smartphone.
This Smartphone had configurations appropriate for accessing the intervention with
good connectivity, streaming speed and picture clarity, and was relatively cheap.
Other key aspects of user-friendliness of the intervention included
1. Light weight of the Smartphone (584 gm).
2. Wide screen of the Smartphone (7”)
3. Video/Picture Quality and detailing (High Definition)
4. Streaming Speed (On Demand - Content Delivery Network [CDN])
5. Application Design and Access features (based on the needs felt by the stroke
survivors)
A stroke survivor reported:
“It’s good that this is in a video format – It would be very difficult for me to read or
understand formal Tamil dialects with the problems in my eyes. I always like to watch TV
and hence I quite like the idea of teaching us ‘what to do’ through videos. Compared to
reading from a book, this is not so boring as well”
Usefulness of the intervention videos:
60% (n=18) of stroke survivors and 50% (n=15) of carers reported that the
intervention was very useful to them. The overall rating that the participants
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provided for the usefulness of the intervention is presented in Table - 2. Stroke
survivors explained that the video format of the intervention was very motivating.
They felt that the intervention provided very useful information about their problem,
the causes for their stroke and the ways to manage their recovery independently. A
stroke survivor who was unable to transfer or walk without support said:
“I can now move from my bed to chair with some support from my sister. I am very happy to
have achieved this. I saw the videos on ‘how to move from one place to another with support’
and I practiced it with my sister. Thank you for helping me with your videos. I am planning
to learn more from it “
Almost all stroke survivors (96%, n=29) felt that the intervention videos were self-
explanatory. The carers explained that the stroke survivors were able to accept the
importance of engaging in their daily living tasks and becoming as independent as
possible in their lives.
Acceptability of the Intervention
Two key features of the intervention that were most strongly valued by the majority
of study participants were
1. The Tamil audio descriptions of the intervention (local language)
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2. The content of the intervention, especially the exercises and daily living task
sections, explained through demonstration by individuals, who resembled
stroke patients from Tamilnadu.
A stroke survivor described:
“I didn’t know that something like this is available in Chennai, I thought all these were in
foreign countries. My son showed me some videos where doctors are speaking in English and
I could not understand much. But I was able to understand many things from these videos on
the phone – it was in Tamil so it was very easy”
Stroke survivors expressed that they were motivated and encouraged to see the
actual performance of daily living tasks using one-handed techniques by someone
like them in the videos.
A stroke survivor described:
“I am surprised that a person with stroke can do things by himself with the strong hand. It’s
eye opening. I felt, why I can’t try. I am now trying some of the tasks that I saw from the
videos, especially to use my hand to eat and dress myself.”
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Acceptability of the Smartphone-enabled Application:
When the study participants were asked about the acceptability of the intervention,
more than half of stroke survivors (57%, n=17) and almost all carers (90%, n=27)
reported that the intervention was definitely acceptable. Overall, 40% (n=12) of the
stroke survivors and 10% (n=3) of the carers felt that the intervention was acceptable
to a great extent (Table 2).
Stroke survivors found the portability of the intervention very useful for them, as
they were able to comfortably watch the intervention videos anywhere they wanted.
Stroke survivors also expressed that portability was very helpful in allowing them to
watch the intervention privately (at home or elsewhere) without disturbing others
and without feeling shy about the discreet content.
“It’s a big family – we are nine people in a single home and one TV for all of us. The TV room
will be busy all the time with lots of family members. This was one important reason why I
prefer the Smartphone instead of a DVD. I take this to any room or even my workplace and
watch, it’s convenient to carry and comfortable to watch – no one knows what I am watching.
Otherwise people will feel pity about my situation”
Caregivers reported that the Smartphone required very minimal physical effort in
terms of carrying or operating it.
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A caregiver explained:
“To get up from your place, go near TV to switch on, find the remote, give connections etc. It
requires lots of work. I have to walk, bend and lift. I can’t do all this with my own problems –
this arthritis. This Smartphone that you gave is a nice choice. Nothing other than movement
of fingers to touch the screen is required. My wife watched it even when she was in bed
sometimes.”
Caregivers also appreciated the size of the Smartphone screen, which was big
enough to watch the videos comfortably without straining the eyes. They expressed
that they were able to access the intervention from their own Smartphone.
Caregivers found the repeatability of the intervention through simple touch and
slide options very comfortable, especially in supporting stroke survivors to
remember important information from the intervention and to reinforce the
importance of recovery. Caregivers also appreciated the design of the application
and the ability to share the intervention videos with others globally.
A caregiver said:
“My daughter, who lives in Singapore, wanted to know what this phone thing is all about. So
we shared the details with her and asked her to watch it. Next day she called us and enquired
whether we are watching it or not and she calls every day to find out what we watched.”
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Overall rating for the Intervention:
Half of the stroke survivors (50%, n=15) and 63% (n=19) of the carers rated ‘Care for
Stroke’ as excellent. The remaining proportion of participants rated the intervention
as very useful (Table 2).
Suggestions by participants:
A major concern voiced by several participants (n=6) was internet connectivity, since
intervention videos were streamed online through the web-based application service.
These six participants were living in remote locations (outskirts of the city) with very
poor connectivity. Participants with a broad band internet connection did not report
any concerns about connectivity and online streaming issues. Two participants (7%)
felt that the intervention could have been provided for longer, whilst several others
reported that the intervention should have been provided when they were first
hospitalised for stroke. Five participants (n=17%) requested a follow-up home visit
by a member of the hospital team to reassess their recovery following stroke. Seven
participants (n=23%) suggested that this intervention should be provided to every
stroke survivor in every hospital and also to the public to prevent further strokes and
its recurrence.
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Clinical Outcomes:
Results from the analysis of clinical outcomes showed statistically significant
improvement in the scores of Barthel Index and MRS between before and after the
intervention period (Table - 3).
Discussion:
The evaluation revealed that there was a minimum of one Smartphone user and one
Smartphone in every participant’s family. This indicates the availability and degree
of Smartphone penetration in a city like Chennai, which makes it potentially feasible
for the Smartphone-enabled carer-supported ‘Care for stroke’ intervention to be
widely used for provision of rehabilitation services in the future. The intervention
was also found to be highly relevant, easily comprehensible, useful, likeable and
satisfying to a greater extent. This implies a high level of acceptability of the
intervention among the study participants. Given the lack of availability and
accessibility of this kind of informational or educational intervention in India, ‘Care
for stroke’ fulfilled an important need among its users.
More than half of the stroke survivors were confident only to some extent in using
the intervention, while this proportion was much lower among the carers. This in
turn could explain why 20% (n=6) of stroke survivors and 25% (n=8) of primary
carers used the intervention only occasionally, and for the two stroke survivors who
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reported that the intervention was useful only to some extent. This may point to the
need for more training for the stroke survivors in the use of the intervention.
Although the results from assessment of clinical outcomes were statistically
significant, the amount of clinical gains obtained by the stroke survivors during the
intervention period was relatively small (20). Furthermore, since there was not a
control group we could not attribute the improvement to the intervention. Given the
clinical significance and the small sample-size in the pilot-testing, the statistical
results obtained from the outcome measures have to be carefully interpreted (21).
However, the objective of using these clinical outcome measures was to look at their
feasibility for their use in future trials of the intervention where a control group
would be used to help attribute cause of improvement in clinical outcomes. Despite a
short intervention period (4 weeks), these clinical outcome measures were able to
detect statistically significant difference, thus establishing their feasibility for use in
future clinical trials and effectiveness evaluations of the ‘Care for Stroke’
intervention.
Field-testing of the intervention facilitated the investigators to address key
operational uncertainties that could have affected feasibility and acceptability. It also
provided an opportunity to review, and revise the intervention before it was pilot-
tested. Pilot-testing of the intervention prior to its effectiveness evaluation assisted
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investigators to understand the factors that could affect feasibility and acceptability
of the intervention. It provided valuable information that could be used to plan and
organize rigorous effectiveness evaluation of the intervention in the future. A phased
approach to the development of the intervention facilitated provision of proper
consideration to the practical aspects of evaluation, providing assurance that the
intervention could be delivered as intended in the future (22).
Accommodating multiple centres from the same geographical location for
recruitment of participants for future studies could hasten the process of participant
recruitment and thereby the evaluation process. Future studies could broaden the
criteria for participant inclusion to more easily achieve the desired sample size and
also to stratify the effects of the intervention by different sub-groups of stroke
survivors.
Conclusion:
Evaluation of the ‘Care for stroke’ Intervention establishes its feasibility in an Indian
context and acceptability among the study stroke survivors and their caregivers. This
makes it possible for the investigators to affirm that provision of a Smartphone-
enabled, carer-supported educational intervention for management of post-stroke
disabilities could be a potential strategy to meet the growing need for stroke
rehabilitation services in settings were rehabilitation resources are very limited.
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Adoption and modification of the ‘Care for Stroke’ intervention, with due attention
to the cultural aspects of the target population, could potentially aid in bridging the
gaps in access to stroke rehabilitation services not just in India but also in other low-
resourced countries where the rehabilitation needs of stroke survivors are
substantial.
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16. Cumming TB, Blomstrand C, Bernhardt J, et al. The NIH stroke scale can
establish cognitive function after stroke. Cerebrovasc Dis. 2010; 30 (1):7-14.
17. Sureshkumar K,Murthy GVS, Munuswamy S, S. Goenka and H Kuper. ‘Care
for Stroke’ a web-based, Smartphone-enabled educational intervention for
management of physical disabilities following stroke: Feasibility in the Indian
context. BMJ Innovations 2015; 1 127–136.
18. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework
method for the analysis of qualitative data in multi-disciplinary health
research. BMC Medical Research Methodology. 2013; 13:117. Doi: 10.1186/1471-
2288-13-117.
19. Van Swieten JC, Koudstaal PJ, Visser MC, et al. Interobserver agreement for
the assessment of handicap in stroke patients. Stroke. 1988; 19: 604–607.
20. Sedgwick Philip. Clinical significance versus statistical significance BMJ 2014;
348: g2130.
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21. Sedgwick Philip. The importance of statistical power BMJ 2013; 347: f6282.
22. Moore Graham, F Audrey Suzanne, Barker Mary, Bond Lyndal, Bonell Chris
et al. Process evaluation of complex interventions: Medical research council
guidance BMJ 2015; 350: h1258.
Funding
This work was supported by a Wellcome Trust Capacity Strengthening Strategic
Award to the Public Health Foundation of India and a consortium of UK
universities.
Ethics approval:
Ethics approval for this research study was obtained from Ethics approval London
School of hygiene and Tropical Medicine, VHS Hospital and Public health
Foundation of India.
Competing Interests
The authors declare that they have no competing interests, financial or non-financial.
Data sharing
No additional data are available.
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Authors’ Contributions
Suresh Kumar. K (SK) conceived, designed and drafted the manuscript. Prof GVS
Murthy and Dr Hannah Kuper played a crucial role in conception of the research
study and provided substantial guidance in designing and conducting the
evaluation. Dr Shifalika Goenka and Dr Subbulakshmy N provided advice related to
conception and actual conduct of the evaluation. Naveen C assisted in carrying out
the quantitative analysis.
Acknowledgement
We thank Wellcome-trust and Public Health Foundation of India for funding the
research study and also the student to undertake the research study as a part of his
doctoral study at the London School of Hygiene and Tropical Medicine. We thank
the ethics committee of the London School of Hygiene and Tropical Medicine, PHFI-
Indian Institute of Public Health - Hyderabad and The Voluntary Health Services
Hospital for granting scientific and ethical approval to conduct this research study.
We thank the members of the expert committee who provided valuable advice on
the development and evaluation of the intervention. We thank colleagues from TINS
VHS who patiently assisted in conducting the evaluation. We also thank consultants
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from Suchir softech and Selva photography for revising the application and digitized
content during the evaluation.
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Tables
Table: 1 Demographic and Clinical Characteristics of the stroke survivors and caregivers in Field-
testing and Pilot-testing.
Characteristics
Participants in
Field -testing
N (%)
Participants in
Pilot -testing
N (%)
Statistical Difference
between the groups
Gender:
- Male:
- Female:
20 (67%)
10 (33%)
18 (60%)
12 (40%)
P = 0.59
P = 0.59
Age: Mean (SD) 54.2 (±14.7) years 57.9 (±11.27) years P = 0.27
Education: Primary school or higher 24 (80%) 26 (87%) P = 0.49
Currently Married 27 (90%) 30 (100%) P = 0.08
Working prior to stroke: 26 (87%) 16 (53%) P = 0.0048**
Currently working: 15 (50%) 3 (10%) P = 0.0007**
Stroke type:
- Ischaemic: 27 (90%) 24 (80%) P = 0.28
- Haemorrhagic: 3 (10%) 6 (20%) P = 0.28
Stroke severity:
- Minor: 12 (40%) 8 (27%) P = 0.27
- Moderate: 18 (60%) 22 (73%) P = 0.27
Affected side:
- Right 18 (60%) 18 (60%) P = 1.00
- Left 12 (40%) 11 (37%) P = 0.79
- Both 0 (0%) 1 (3%) P = 0.31
Level of dependence:
- Independent-personal care: 15 (50%) 7 (23%) P = 0.032**
- One Person Assistance: 15 (50%) 23 (77%) P = 0.032**
Receiving Physiotherapy 8 (27%) 8 (27%) P = 1.00
Using mobility aids: 9 (30%) 6 (20%) P = 0.37
Smartphone users 11 (37)% 3 (10)% P = 0.015**
Demographic Characteristics of the Caregivers
Characteristics
Participants in
Field -testing
N (%)
Participants in
Pilot -testing
N (%)
Gender:
- Male:
- Female:
15 (50%)
15 (50%)
11 (37%)
19 (63%)
P = 0.30
P = 0.30
Age: Mean (SD) 31.63 (±7.66) years 39.5 (±13.7) years P = 0.008**
Education Primary school or higher 30 (100%) 29 (97%) P = 0.31
Employed: 21 (70%) 27 (90%) P = 0.05
Primary caregivers: 16 (53%) 25 (83%) P = 0.012**
Own a Smartphone: 21 (70%) 21 (70%) P = 1.00
Smartphone users 28 (93)% 18 (60%) P = 0.012**
** p < 0.05 significant difference in group
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Table - 2: Details of participant responses from the satisfaction survey (Pilot-testing)
Participants Initial impression about the intervention
Interesting
N (%)
Encouraging
N (%)
Motivating
N (%)
Consoling
N (%)
All
N (%)
None
N (%)
Stroke
survivors 7 (23%) 3 (10%) 1 (3%) 17 (57%) 2 (7%) 0 (0%)
Caregivers 9 (30%) 6 (20%) 10 (33.3%) 4 (13.3%) 1
(3.3%) 0 (0%)
Need for training and support to access the intervention
Need
Support
from
others
N (%)
Can Manage Myself
N (%)
Need
Training
N (%)
Need Training
and support from
others
N (%)
Not sure
N (%)
Stroke
survivors 24 (80%) 4 (13%) 1 (3%) 0 (0%) 1 (3%)
Caregivers 4 (13%) 23 (77%) 2 (7%) 0 (0%) 1 (3%)
Overall Confidence to use the Intervention
Definitely
Confident
N (%)
Confident to a
greater extent
N (%)
Confident to
some extent
N (%)
Confident to
a small extent
N (%)
Not confident
N (%)
Stroke
survivors 3 (10%) 9 (30%) 17 (57%) 1 (3%) 0 (0%)
Caregivers 17 (57%) 12 (40%) 1 (3%) 0 (0%) 0 (0%)
Utilisation pattern of the intervention – The intervention was used
More than
once
weekly
N (%)
Whenever
possible
N (%)
More than
once daily
N (%)
whenever
necessary
N (%)
Did not use
N (%)
Stroke
survivors 15 (50%) 14 (47%) 1 (3%) 0 (0%) 0 (0%)
Caregivers 14 (47%) 9 (30%) 2 (6%) 5 (17%) 0 (0%)
Practicing the skills learnt from the intervention
Practice
Always
N (%)
Practice
Frequently
N (%)
Practice
Occasionally
N (%)
Practice
Rarely
N (%)
Never
Practice
N (%)
Stroke
survivors 7 (23%) 16 (53%) 6 (20%) 1 (3%)
0 (0%)
Caregivers 7 (23%) 15 (50%) 8 (27%) 0 (0%) 0 (0%)
Overall Usefulness of the intervention
Definitely
Useful
N (%)
Useful to a great extent
N (%)
Useful to
some extent
N (%)
Useful to a
small extent
N (%)
Not
useful
N (%)
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Stroke
survivors 19 (63%) 9 (30%) 2 (7%) 0 (0%) 0 (0%)
Caregivers 9 (30%) 20 (67%) 1 (3%) 0 (0%) 0 (0%)
Overall likeableness of the intervention
Yes Definitely
N (%)
Yes to a Great extent
N (%)
Yes to Some extent
N (%)
Stroke
survivors 17 (57%) 12 (40%) 1 (3%)
Caregivers 27 (90%) 3 (10%) 0 (0%)
Overall Rating for the Smartphone-enabled Intervention
Excellent
N (%)
Very Useful
N (%)
Satisfactory
N (%)
Stroke
survivors 16 (53%) 13 (43%) 1 (3%)
Caregivers 20 (67%) 10 (33%) 0 (0%)
Overall Rating for the usefulness of the Intervention
Extremely useful
N (%)
Very Useful
N (%)
Useful to an extent
N (%)
Stroke
survivors 11 (37%) 17 (57%) 2 (7%)
Caregivers 16 (53%) 14 (47%) 0 (0%)
Interesting sections of the intervention for the participants
All Sections
N (%)
Stroke
Information
Section
N (%)
Stroke
Information
and
exercises
Sections
N (%)
Stroke
Information
and ADL
Sections
N (%)
Stroke
Information
and
Functional
skills
sections
N (%)
Exercises
section
N (%)
Stroke
survivors 12 (40%) 7 (23%) 5 (17%) 4 (13%) 1 (3%) 1 (3%)
Caregivers 17 (57%) 5 (17%) 4 (13%) 2 (7%) 0 (0%) 2 (7%)
ADL – Activities of Daily Living
Table - 3: Details from the analysis of the outcome measures (Pilot-testing)
Outcomes
Pre-
Intervention
(Baseline)
Post-
intervention
(End point)
Mean Difference with
95% CI
Test for overall
Change in scores
Barthel Index
Mean (SD) 57.8 (± 26.6) 70 (± 25.8)
-12.2
(-15.3, -9.0)
-7.86
P < 0.00001**
Modified Rankin Scale
Mean (SD) 3.2 (± 0.8) 2.7 (± 1.1)
0.5
(0.3, 0.7)
5.75
P < 0.00001**
**p < 0.05 significant difference in group
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ORIGINAL ARTICLE
‘Care for Stroke’, a web-based,smartphone-enabled educationalintervention for management ofphysical disabilities following stroke:feasibility in the Indian context
K Sureshkumar,1 G V S Murthy,1 Suresh Munuswamy,2 Shifalika Goenka,3
Hannah Kuper1
1International Centre forEvidence in Disability, LondonSchool of Hygiene and TropicalMedicine, London, UK2Institute of PublicHealth-Hyderabad,Hyderabad, Telangana, India3Institute of Public Health-Delhi,Gurgaon, Haryana, India
Correspondence toSureshkumar Kamalakannan,International Centre for Evidencein Disability (ICED), LondonSchool of Hygiene and TropicalMedicine, Keppel Street,London, WC1E 7HT, UK;[email protected]
Received 10 April 2015Accepted 16 May 2015
To cite: Sureshkumar K,Murthy GVS, Munuswamy S,et al. BMJ Innov 2015;1:127–136.
ABSTRACTIntroduction Stroke rehabilitation is a processtargeted towards restoration or maintenance ofthe physical, mental, intellectual and socialabilities of an individual affected by stroke.Unlike high-income countries, the resources forstroke rehabilitation are very limited in many low-income and middle-income countries (LMICs).Provision of cost-effective, post-strokemultidisciplinary rehabilitation services for thestroke survivors therefore becomes crucial toaddress the unmet needs and growingmagnitude of disability experienced by the strokesurvivors in LMICs. In order to meet the growingneed for post-stroke rehabilitation services inIndia, we developed a web-based Smartphone-enabled educational intervention formanagement of physical disabilities following astroke.Methods On the basis of the findings from therehabilitation needs assessment study, guidancefrom the expert group and available evidencefrom systematic reviews, the framework of theintervention content was designed. Web-basedapplication designing and development byProfessional application developers weresubsequently undertaken.Results The application is called ‘Care forStroke’. It is a web-based educationalintervention for management of physicaldisabilities following a stroke. This intervention isdeveloped for use by the Stroke survivors whohave any kind of rehabilitation needs toindependently participate in his/her family andsocial roles.Discussion ‘Care for stroke’ is an innovativeintervention which could be tested not just for its
feasibility and acceptability but also for its clinicaland cost-effectiveness through rigorouslydesigned, randomised clinical trials. It is veryimportant to test this intervention in LMICswhere the rehabilitation and information needsof the stroke survivors seem to be substantialand largely unmet.
BACKGROUNDStroke rehabilitation is a process targetedtowards restoration or maintenance ofthe physical, mental, intellectual andsocial abilities of an individual affectedby stroke.1 Stroke rehabilitation enablesthe stroke survivor to perform his/herdaily activities at an optimal functionallevel and helps the stroke survivor to par-ticipate in his/her social roles as inde-pendently as possible.2 The strokesurvivor relearns the skills that are lost orimpaired due to brain damage followingstroke through rehabilitation.3
An insult to the human brain due tostroke might have various effects on thestroke survivor, and hence healthcareprofessionals from various disciplineshave to provide the stroke survivor witha patient-centred, comprehensive, multi-disciplinary rehabilitation.4 Unlike high-income countries (HICs), the resourcesfor rehabilitation, especially the rehabili-tation workforce and infrastructure,are very limited in many low andmiddle-income countries (LMICs).5 If wetake India as an example, rehabilitationservices are often unidisciplinary, drivenpredominantly by physiotherapists, with
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lack of support from occupational therapists, speechtherapists and so on. Many government-run districtrehabilitation centres are non-functional and theprivate hospitals are staffed with only a physiotherap-ist in their rehabilitation centres.6 Given the scarceresources, the rehabilitation needs of the stroke survi-vors, especially in the LMICs, remain largely unmet.7
Provision of cost-effective, post-stroke multidisciplin-ary rehabilitation services for the stroke survivorstherefore becomes crucial to address the unmet needsand growing magnitude of disability experienced bythe stroke survivors in LMICs.The past few years have seen a tremendous increase
in the use of Smartphones by health professionals andalso by the general public.8 Evidence from a recentsystematic review suggests that Smartphones could bean extremely useful tool to educate patients tomanage their health problems.9 Another systematicreview on the use of Smartphone applications forstroke rehabilitation also demonstrates the advantagesof Smartphone applications for provision ofstroke-related information.10 These Smartphone appli-cations are regarded as important by health profes-sionals providing stroke rehabilitation themselves.10
In order to meet the growing need for post-strokerehabilitation services in India, we developed a web-based Smartphone-enabled educational interventionfor management of physical disabilities followingstroke. This paper provides a detailed description ofthe intervention and the processes involved in itsdevelopment. The paper also discusses the importanceof such rehabilitation interventions for meeting theunmet needs of the stroke survivors.
DEVELOPMENT OF THE CONTENT FOR THEINTERVENTIONSystematic review of the available interventionsEvidence from systematic reviews in relation to strokerehabilitation and information provision for strokesurvivors and caregivers was extensively used todevelop the intervention. We also conducted a com-prehensive and a global systematic review on educa-tional interventions for reducing disabilities inacquired brain injury to investigate the evidence thatwas available to develop this intervention.
Rehabilitation needs assessment studyThe content of the intervention was developedprimarily based on the needs expressed by the strokesurvivors and caregivers who participated in a rehabili-tation needs assessment study carried out exclusively todevelop this intervention. The rehabilitation needsassessment study was carried out to guide the develop-ment of a need-based rehabilitation intervention andhad two components in it. One was a structured surveywith 50 stroke survivors and their caregivers to identifythe various kinds of rehabilitation needs that theyexperience. The other was a detailed in-depth
interview with a subsample of the stroke survivors andcaregivers selected for the survey. The purpose of thein-depth interviews was to gain a detailed understand-ing of the experiences of the stroke survivors in rela-tion to accessing stroke rehabilitation services and theirrehabilitation needs following a stroke. In-depthinterviews with health professionals involved in theprovision of stroke rehabilitation services were alsocarried out to understand the perspective of thehealth professionals about provision of strokerehabilitation services, their knowledge about theexisting Smartphone-based health interventions andtheir attitudes and opinions about the use of aSmartphone-enabled, care-supported education pro-gramme for domiciliary stroke rehabilitation.
Expert group for content developmentIn addition to the needs assessment, expert guidancewas obtained from a team of eight highly qualifiedand experienced health professionals from variousneurorehabilitation disciplines (physical medicine andrehabilitation, neuropsychiatry, clinical psychology,occupational therapy, physiotherapy, social sciences,information technology, public health and m-health)with both national and global expertise in the field ofneuropsychiatric rehabilitation. The expert team alsoincluded three stroke survivors and their primary care-givers. All the team members were from Tamil Naduand they were Tamil-speaking. The key characteristicsof the expert group, such as their experience, expert-ise, global exposure and language, facilitated thedevelopment of a culturally specific, patient-centredintervention for management of physical disabilitiesfollowing a stroke.
Framework of the intervention contentOn the basis of the findings from the rehabilitationneeds assessment study, guidance from the expertgroup, and available evidence from systematic reviews,the framework of the intervention content wasdesigned. The content framework included fiveimportant sections related to post-stroke rehabilita-tion. The sections were:1. Information about stroke (know more about stroke)2. Exercises (home-based exercises)3. Functional skills training (preparing oneself for daily
living)4. Activities of daily living (engaging in activities of daily
living)5. Assistive devices (devices to assist daily living).
CONTENT OF THE INTERVENTION SECTIONSKnow more about strokeAs the section title suggests, this section enables thestroke survivors and caregivers to know more aboutstroke, the impact of stroke on an individual experien-cing it and advice from experts on the way forward(life after a stroke). The important subsections/topics
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and videos that this section includes are provided intable 1.The primary objective of having this section is to
create awareness and enable the stroke survivors andtheir caregivers to gain more knowledge about stroke,because this would assist them in preventing recurrentstroke, modifying their lifestyle, making treatmentdecisions and planning for life after a stroke.
Home-based exercisesThis section includes home-based, task-oriented exer-cises that the stroke survivors can practise in theirhome in order to maintain or improve their bodyfitness for functional activities. These exercises arebased on eclectic treatment approaches to strokerehabilitation (motor relearning, functional, neurode-velopmental frame of references for therapy) thatenable the stroke survivors to use their affected partsof the body and engage in functional activities.These home-based exercises include the use of
equipment like a chair or bed and table that are com-monly available in most homes in India. They do notrequire the purchase of any sophisticated exerciseequipment. Principles of safety and risk/hazard pre-vention have been thoroughly considered while
developing this section. Some of the important sub-sections/topics and videos that this section comprisesare listed in table 2.The objective of developing this section content is
to enable the stroke survivors to understand the rele-vance of the conscious use of the affected parts of thebody following a stroke and also the importance ofexercises for engaging in functional activities rather
Table 1 Content of ‘know more about stroke’ section
Content of the intervention
Main sections Subsections Videos
Information about stroke ▸ What is a stroke?▸ What is a transient ischaemic attack (TIA)?▸ How does a stroke happen?▸ Warning signs of a stroke▸ What are the common symptoms of a stroke?▸ How does a stroke affect your body?▸ Risk factors for a stroke▸ Common effects of a stroke▸ Recovering from a stroke
▸ What is a stroke?▸ How does a stroke happen?▸ What is a transient ischaemic attack▸ Symptoms of a stroke▸ Effects of a stroke▸ Modifiable and non-modifiable risk factors for a stroke▸ Effects of a stroke on– Balance– Bowel and Bladder– Thinking– Pain– Physical problems– Sleep and fatigue– Sensation– Sleep and fatigue– Speech and language– Swallowing
▸ Recovery from a stroke by– Public health experts– a neuropsychiatrist– a neurologist– a physiotherapist– an occupational therapist– a clinical psychologist– a disability rights expert
Table 2 Content of ‘Exercises’ section
Content of the intervention
Mainsections Subsections Videos
Exercises ▸ Upper limbexercises
▸ Lower limbexercises
▸ Balance exercises▸ Active exercises▸ Exercises to
improve upper limbfunction
▸ Passive upper limb exercises▸ Passive lower limb exercises▸ Active-assisted exercises for
the lower limb▸ Active exercises for the
upper limb▸ Exercises for the trunk▸ Exercises for balance▸ Improving awareness and
function of the affectedhand
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than just exercising and improving the flexibility,strength and movement of the affected body part.
Preparing oneself for everyday livingFunctional skills are a prerequisite to participate ineveryday living. One should know how to get upfrom a lying down position. In order to sit properlyand feed or groom, one should know how to transferfrom a bed to a chair or a commode for bathing ortoileting. These are very important to the stroke sur-vivor who cannot or finds it difficult to move theaffected part of his/her body. This section highlightsfunctionally oriented tasks that the stroke survivorscan learn in order to participate in their day-to-dayactivities.Exercise training provided by a physiotherapist to
the stroke survivors is directly related to the develop-ment of functional skills of the individual affected bystroke. Hence, this section stresses the importance offunctional skills to participate in everyday living andpreparing oneself for everyday living by acquiring func-tional skills. Some of the important subsections/topicsand videos of this section are depicted in table 3.
Engaging in activities of daily livingThis section comprises adaptive methods and techni-ques to engage in activities of daily living like groom-ing, bathing, dressing and eating. The stroke survivors
can watch, learn and practise these adaptive techni-ques to independently perform their activities ofeveryday living. The content of this section is depictedin table 4.This section is very important from the viewpoint
of both the stroke survivors and their caregivers. Thisis because learning to purposefully engage in one’sown everyday living seems to be an important needand crucial task for the stroke survivors to independ-ently participate in his/her personal, family and soci-etal roles. Although the stroke survivors learn to doexercises and acquire knowledge to manage their pro-blems post-stroke, the overall objective behind theacquisition of these skills and knowledge is to live afunctionally independent life and perform theirvarious roles at home and society actively (table 5).
Devices to assist daily livingThis is a unique section that enables the stroke survi-vors and their caregivers to understand the import-ance of using assistive devices that are readily availablein India and that can assist the stroke survivor toengage in their day-to-day activities independentlyand also with confidence. This section also includesdevices that are tailor-made to the needs of the strokesurvivors living in the southern part of India like anadapted saree, Velcro-based blouse, adapted dhoti andlungi, etc. This section also has devices that are notavailable in India but can be designed and fabricated
Table 3 Content of ‘Exercises’ section
Content of the intervention
Mainsections Subsections Videos
Functionalskills training
▸ Positioning the strokesurvivor in bed and ina chair
▸ Bed mobility▸ Transfers▸ Standing up from a
sitting▸ Mobility/ambulation
training
▸ Positioning on– the Chair –– the Bed –affected
side– the Bed –
unaffected side– the Bed—Lying on
the back▸ Bed Mobility– Rolling on the bed– Scooting on the
bed– Coming up to a
sitting▸ Sit to Stand
(moderate support)Transfers
– Independenttransfers (bed tochair/wheelchair)
– Transfers withmaximum support
▸ Walking
Table 4 Content of ‘Activities of daily living’ section
Content of the intervention
Main sections Subsections Videos
Activities of daily living ▸ Brushing▸ Feeding▸ Bathing▸ Grooming▸ Dressing
▸ Brushing▸ Feeding▸ Bathing▸ Grooming▸ Washing face▸ Wearing a T-shirt▸ Wearing a Shirt▸ Wearing a dhoti/lungi▸ Wearing a pant▸ Wearing a saree▸ Wearing a blouse▸ Undressing
Table 5 Content of ‘Devices to assist daily living’ section
Content of the intervention
Mainsections Subsections Videos
Assistivedevices
▸ Personal care aids▸ Mobility aids▸ Orthoses and supports
▸ Personal care aids▸ Mobility aids▸ Orthoses and supports
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by the stroke survivors themselves and their care-givers, for example, the universal cuff that can assistthe stroke survivor to use their affected hand forfeeding, brushing, writing and grooming. The keytopics covered under this section is provided intable 5.The primary objective of this section is to inform
the stroke survivors of the importance of assistivedevices that can be used to perform everyday activitiesindependently and safely. Assistive devices can boostthe confidence of the stroke survivor to engage intheir everyday tasks. It also reduces the assistance andsupport provided by the caregivers, thereby reducingthe physical strain in providing care and support forthe stroke survivor in their daily living tasks.
DESCRIPTION OF THE INTERVENTIONNaming the applicationThis application was intended to educate the strokesurvivors and their caregivers to manage their physicaldisabilities following stroke. Therefore, the web-basedapplication was named ‘Care for Stroke’ to emphasisethe importance of enhancing the life of individualsexperiencing stroke and continuum of care that isessential for a stroke survivor.
Logo and tagline of the applicationThe logo of the application was created by the princi-pal investigator himself under the supervision ofexperts from the field of disability, rehabilitation anddesign (figure 1). The logo depicts a stroke survivoraccepting support from another person in a homeenvironment and trying to mobilise himself/herself.The design of the logo stresses the importance of thestroke survivor accepting support from anotherperson and actively engaging in functional activitieswhile staying at home.The tagline of the application is ‘Think Smart—
Take Control’. This tagline emphasises the importanceof proactive, innovative and smart planning fortherapy and rehabilitation services that the stroke sur-vivor and their caregivers should execute, outside thehospital environment. It also encourages the strokesurvivors to take control of their problems followingstroke and work towards an independent life after astroke.
Design of the web-based applicationThis intervention is designed as a web-based applica-tion that uses a website as an interface (the front end).The introductory web page of the application isshown in figure 2 Users can access the application notjust from Smartphones but also from a computer,PDA, Tablet and even digital television that is con-nected to the internet using any standard webbrowser. Some of the key design features of this appli-cation are: User interface, content format, language.
User interfaceAn interface enables a user to interact with a system(Smartphone in this instance) to perform a task. Forexample: Navigating to different web pages in thiswebsite enables a user to find the video content thathe/she prefers to watch. The users can watch thevideos by navigating through user-friendly interfacessuch as the touch and slide option which requires theusers to either touch or slide the icons (ie, picturesand symbols) and pages in the application to watchthe videos they want.
Content formatThis application is exclusively designed to supportdigitised audio–visual content. More than 75% of thecontent of this application is in the form of videos.The users can interact with the images related to themain sections and watch the videos about stroke andthe management of physical disability post-stroke
Figure 1 Logo of the application. Figure 2 Introductory page of the ‘care for stroke’ application.
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through this application. There is very minimalrequirement for the users to read written informationin this application.
LanguageThis application is built with multilingual functional-ity and it currently supports English and Tamil, thenative language of the State of Tamil Nadu in Indiawhere it was piloted.
Technical description of the applicationThe application is built using a LAMP (Linux,Appache, MySQL, PHP) environment. The user inter-face of the application was designed using HTML5,CSS3, Bootstrap, Java Script, JQuery, Ajax, Googlefont API and Touch Swipe. It is to ensure that theuser interface acts as a responsive and interactivedesign. Designing the application with these technolo-gies supports the application to be installed and runon multiple devices like desktop, laptop, IPhone,IPad, Android devices andWindows devices.The back end of the application was built in PHP5
(PHP—Hypertext Processor) language. This is tofacilitate the user to interact with the database(MySQL) and view the requested information withoutany difficulty. Given the issues with video streamingin a country like India (ie, very slow internet connect-ivity and streaming), this application uses Cloud FlareCDN (Content Delivery Network) that enhances thequality and speed of the video streaming while theuser is accessing the videos from the application.This application also has an administrator module,
where the administrator can monitor all the activitiesof the users who have logged into the application. Itcan also generate different types of reports of the userinteraction with the application. Some of the keyinformation that could be monitored are:▸ The title of the sections and videos viewed,▸ Duration of the logged in session▸ Date and time of viewing▸ Number of sections and videos watched during a logged
in session.▸ Device used for logging in▸ Time spent on application,▸ Geo-location information.
STRUCTURE AND FUNCTIONALITY OF THEAPPLICATIONRegistered websiteThis web-based application can be accessed from theregistered website name http://www.careforstroke.com
Home pageThe application has a home page that briefly describesstroke and stroke-related disability in the vernacular(Tamil). First-time users cannot access the interventionwithout registering themselves. This is to ensure pro-active engagement of the users, observe their
utilisation pattern and to generate utilisation reportsfor future evaluations. The home page providesdetails of registration with an icon to register the first-time users. Users who have already registered toaccess the intervention can use the same icon to accessthe sign-in page (figure 2). There is a drop-down iconin the home page to change the language of the appli-cation if required. Currently, the application pageshave the descriptions in English and Tamil.
Sign-in page and registrationThis page contains an icon for first-time users to regis-ter and the sign in boxes with user name and pass-word sections to be filled by the user to sign into theapplication.
Registration pageThis page contains a drop-down box, where the usercan identify and register themselves as a stroke sur-vivor or caregiver of the stroke survivor. This helpsthe investigator or administrator to monitor theengagement and usage of the application by the strokesurvivors and caregivers separately. On the basis of theoptions chosen, the user will be redirected to the spe-cific registration page with drop-down options andtext boxes to fill in the user details requested andregister onto the application. After completing theregistration, users will be redirected back to thesign-in page. Registration requires the users to have ausername and password to ensure identity and privacy(figure 3).
Intervention pageAfter the user signs into the application successfully,the application is redirected to the main interventionpage. This page contains brief written informationabout the intervention and five important sectionsthat contain the content of the ‘care for stroke’ inter-vention (figure 4).Sections: There are five main sections displayed as
photographic icons on the intervention page whichcan be touched and explored further (figure 4). Thesefive sections contain digitised information (videos)about stroke and the various aspects that a stroke sur-vivor can view and understand about the managementof the physical disabilities following a stroke (figure 5).Subsections: When the user touches an icon on the
section page, it is redirected to the corresponding sub-section page that comprises topics (subsections) thatthe respective section contains. For example, the mainintervention page will contain a photograph of thestroke survivor performing his Activities of DailyLiving—ADL (intervention page); if the user touchesthis icon, it will take him or her to the ADL section(figure 5). If the user touches this ADL section icon,the web page will be redirected to the ADL subsectionpage that contains topics with video icons (images)related to ADL, in this instance, stroke survivors
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performing brushing, feeding, dressing, etc. Pleasefind the section web page in figure 6.Content digitised videos: When the user touches a
topic in the subsection, the web page will be redir-ected to a page that contains detailed informationabout that topic in the form of 3–5 min video clips.For example, if the user touches the topic ‘Wearing ablouse’, the web page will be redirected to a video cliprelated to that topic. These videos are streamed onlinethrough internet or mobile internet networks and canbe watched by touching the play button on the videoclip. Please find the video section of the application infigure 7 below.
Shuffling between the web pagesUsers can shuffle between the pages by either1. Pressing the back button on the Smartphone2. Pressing the back icon on the web page3. Sliding the web pages back and forth using the touch
screen option on the Smartphone.In addition to this, the user can return to the main
intervention page at any time by touching the logowhich is located on top of every web page of theapplication.
Administrator moduleThis Smartphone-enabled intervention is built with anadministrator module, where the usage and utilisation
Figure 4 Intervention page.
Figure 3 Registration page.
Figure 5 Section page.
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patterns of this application by the users can be trackedcontinuously and reports can be generated to informthe feasibility of this intervention and also to monitorthe progress of any programmes/research projectsrelated to this intervention when scaled up to a largercommunity of stroke survivors. The administrator canalso add videos onto (or remove videos from) theapplication as and when required, thereby customisingor improvising the content of the intervention accord-ing to the needs of the users. The module is protectedand strictly secured through a username and passwordto ensure privacy and confidentiality of the userinformation.
DISCUSSIONStroke is one of the leading causes of death and dis-ability worldwide.11 Globally, nearly six millionpeople die from stroke each year, and much of this
stroke burden is borne by LMICs.12 Though theprimary focus of many LMICs, including India, is toprevent stroke by reducing the prevalence of its riskfactors, similar attention should also be given to thosewho survive a stroke and are disabled post-stroke.13 14
Unlike HICs, organised multidisciplinary rehabilita-tion services for stroke survivors are not available inmany LMICs.15–17 Given the context of many LMICswith a scarce rehabilitation workforce and resourcesfor rehabilitation, it is critically important to developinnovative post-stroke rehabilitation interventions thatcould address the growing magnitude of post-strokedisability and meet the rising need for rehabilitationservices in these countries.The international telecommunication union esti-
mated that six billion people were mobile phone usersduring 2011 globally, which is equivalent to 87% ofthe world’s population. This report has also documen-ted that India is one of the top markets forSmartphone sales globally.18 The management ofchronic diseases using Smartphone technology hasbeen described in a recent systematic review.19 Thisreview identified 15 Smartphone applications formanagement of chronic conditions. Out of these 15applications, there was only one application calledMayo clinic meditation that was similar to the‘Careforstroke’ application. The Mayo clinic applica-tion helped patients practise meditation through a15 min training video on meditation.Some of the Smartphone applications used in stroke
rehabilitation in HICs include the Dr Droid applica-tion that helps therapists to administer and trackupper limb exercises for stroke rehabilitation,20 theThink-FAST application that features stroke preven-tion information and a list of stroke unit locations inAustralia21 and PTX, a physiotherapy exercise applica-tion for individuals with any kind of neurological con-ditions that includes a pictorial description of theexercises for stroke survivors.22 The National Instituteof Clinical Excellence (NICE) guidelines for long-termstroke rehabilitation also recommend the use ofSmartphones for communication problems in patientswith stroke.23
A chronic condition like stroke requires uninter-rupted therapeutic care and constant monitoringduring the entire continuum of recovery.24 In theabsence of any organised stroke care services and withthe limited resources for rehabilitation, aSmartphone-enabled educational intervention formanagement of disabilities could be a strategy to meetthe substantial rehabilitation needs of stroke survivorsin India. The evidence concerning the use ofSmartphones in chronic disease care in India is justemerging and the use of Smartphones in health inter-ventions to combat diseases like diabetes, hyperten-sion and cardiovascular diseases is progressively beinginvestigated.25 Adoption of this strategy could possiblyreduce the barriers to access and availability of strokeFigure 7 Video section of the application.
Figure 6 Subsection page.
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rehabilitation services. It could also aid in efficientand sustained monitoring of patient progress through-out the continuum of care.‘Care for stroke’ is a Smartphone-enabled educa-
tional intervention for management of physical dis-abilities following a stroke. The content of theintervention was developed systematically and primar-ily based on the needs of the stroke survivors andinformed by existing global evidence. It includesinputs from highly qualified and experienced multidis-ciplinary stroke rehabilitation professionals in a digi-tised audio–visual format that is more entertaining towatch and learn compared to the other methods ofpatient education such as an educational workbookand group teaching or lectures.This intervention is culture-specific and language–
specific, and therefore the users can easily understandand adapt the techniques to manage their post-stroke-related disabilities. Since the intervention is loaded ontoa Smartphone, the user can access the intervention asand when they need. Unlike television and DVDplayers, Smartphones are portable and handheld andhence it might aid the user to access the interventionconveniently (without having to plug wires, operate aremote to watch videos or depend on electricity).This Smartphone-based, technology-driven inter-
vention can be less demanding in terms of the physicalabilities required by the users to learn, when com-pared with other kinds of educational interventionslike attending group sessions, using a stroke workbookor watching a DVD educational material about stroke.The application for accessing the intervention is web-based, and hence the users can also access the contentthrough their laptops, desktops and tablets if required.From the point of view of programme managers and
evaluators, this kind of web-based educational interven-tion can continuously monitor the usage and utilisationpattern of the intervention by each user, and it can behelpful to generate reports to monitor the efficiencyand effectiveness of this intervention while scaling up,without having to contact the users. Since the interven-tion is Smartphone-enabled and web-based, the usercan contact the service provider directly by dialling thecontact numbers on the Smartphone or by making askype call using the mobile internet services.This Smartphone-enabled intervention might also
motivate the caregivers and family members to com-prehend the importance of stroke rehabilitation andsupport the stroke survivors in utilising the keyaspects of the intervention in their everyday life. Froma financial perspective, the cost of using thisSmartphone-enabled intervention might be less costlycompared to the other ways of accessing informationabout stroke and the ways to manage post-stroke phys-ical disability from rehabilitation experts or hospitals.The ‘Care for stroke’ application is currently under
pilot testing for its feasibility and acceptability with asmall group of stroke survivors and their caregivers
in Chennai, India. If this application is found feasibleand acceptable, the investigators intend to look atthe clinical and cost-effectiveness of this interven-tion. To date and to the best of our knowledge, therehas not been a web-based, Smartphone-enabled edu-cational application and intervention for stroke survi-vors with a primary focus on the rehabilitationaspect of the stroke. In a global context and from apublic health perspective, ‘Care for stroke’ is onesuch kind of innovative intervention which could betested not just for its feasibility and acceptability butalso for its clinical and cost-effectiveness throughrigorously designed, randomised clinical trials. It isvery important to test this intervention in LMICswhere the rehabilitation and information needs ofthe stroke survivors seem to be substantial andlargely unmet.
Acknowledgements The authors thank the student forundertaking the research study as a part of his doctoral study atthe London School of Hygiene and Tropical Medicine. Theauthors thank the ethics committee of the London School ofHygiene and Tropical Medicine, PHFI-Indian Institute of PublicHealth—Hyderabad and The Voluntary Health ServicesHospital for granting scientific and ethics approval to conductthis research study. The authors also thank the professionalsoftware and technical consultants at Suchirsoftech (India) whodeveloped the web-based application. The authors thank theexpert committee members for assisting in the development ofthe content for the intervention. The authors thank the mediaprofessionals at Selva photography (India) for digitising thecontent for the intervention. The authors also thank the modelswho acted for content digitisation. The authors also thank allthe stroke survivors and their caregivers for their participationand inputs in developing this intervention.
Contributors SK (Doctoral student at LSHTM) conceived thestudy, designed and developed the intervention and drafted themanuscript. GVSM and HK played a pivotal role inconceptualising the stages involved in the development of theintervention and reviewed the manuscript. SM providedsubstantial guidance for the technical development of theweb-based application. SG provided guidance in the concept ofthe research study.
Funding This work was supported by a Wellcome TrustCapacity Strengthening Strategic Award to the Public 542Health Foundation of India and a consortium of UKuniversities. The authors thank the Wellcome-trust and PublicHealth Foundation of India for funding the research study.
Competing interests None declared.
Patient consent Obtained.
Ethics approval London School of hygiene and TropicalMedicine, VHS Hospital and Public health Foundation of India.
Provenance and peer review Not commissioned; internally peerreviewed.
Open Access This is an Open Access article distributed inaccordance with the terms of the Creative CommonsAttribution (CC BY 4.0) license, which permits others todistribute, remix, adapt and build upon this work, forcommercial use, provided the original work is properly cited.See: http://creativecommons.org/licenses/by/4.0/
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14 Durai Pandian J, Padma V, Vijaya P, et al. Stroke and thrombolysisin developing countries. Int J Stroke 2007;2:17–26.
15 Langhorne P, de Villiers L, Pandian JD. Applicability ofstroke-unit care to low-income and middle-income countries.Lancet Neurol 2012;11:341–8.
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17 Boulos MN, Wheeler S, Tavares C, et al. How smartphones arechanging the face of mobile and participatory healthcare: anoverview, with example from eCAALYX. Biomed Eng Online2011;10:24.
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contextfollowing stroke: feasibility in the Indianfor management of physical disabilities
interventionsmartphone-enabled educational 'Care for Stroke', a web-based,
and Hannah KuperK Sureshkumar, G V S Murthy, Suresh Munuswamy, Shifalika Goenka
doi: 10.1136/bmjinnov-2015-0000562015 1: 127-136 BMJ Innov
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Study Phase - 3
Assessment form for Individuals with Stroke
Participant Study ID: Date of Assessment
Demographic Details of the Stroke Survivor
Name: Age:
Gender: Male / Female
Education: No Education; Primary School; Secondary School; Diploma; Degree; Post Graduate;Professional Course
Occupation prior to stroke: Daily wage labor; Class IV Govt/Pvt; Class III/II Govt/Pvt; Class I (Govt)/Pvt; Petty Business; Household work; Not working
Current occupation if any: Daily wage labor; Class IV Govt/Pvt; Class III/II Govt/Pvt; Class I (Govt)/Pvt; Petty Business; Household work; Not working
Change in Occupation:
Annual Family income:
Address:
Contact Number
Primary Caregiver: Secondary Caregiver:
Internet facility at home: Yes/No
Details of Smartphone use:
Experience of using a smartphone prior to stroke: Yes / No
If yes, how long
Does the stroke survivor own a Smartphone: Yes / No
Experience of the Primary caregiver in using a smartphone prior to stroke: Yes / No
If yes, how long
Does the Primary caregiver own a Smartphone: Yes / No
Experience of the Secondary caregiver in using a smartphone prior to stroke: Yes / No
If yes, how long
Does the Secondary caregiver own a Smartphone: Yes / No
Study Title: Development of a Smartphone-enabled carer-supported educationalintervention for management of disabilities following stroke in India
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Clinical Details of the Stroke Survivor
Hospital number:
CT Diagnosis:
Stroke Type: Ischaemic / Haemorrhagic
Date of Onset: Admission Date: Discharge Date:
Time since first stroke (in months):
Previous stroke if any: Yes / No
NIH Stroke scale score:
Stroke Severity: Mild / Moderate / Severe
Side Affected: Right / Left
Upper limb Involvement:
Dominance: Right / Left
Any severe cognitive difficulties: Yes / No
Any severe communication problem: Yes / No
Any Severe co-morbidities (severe psychiatric illness, hearing loss, vision loss): Yes / No
Functional status prior to stroke: Independent / Partially Independent / Dependent
Caregiver Details:
S.No Name Age Gender Education Occupation Relationshipto the strokesurvivor
Activitiesfor whichsupport isprovided,whilecaregiving
Approximatetime spent incaregiving perday
Additional Information if any:
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For peer review only
Study Phase – 3: Satisfaction Survey
Assessment form for Individual with Stroke
Participant Study ID: Date of Assessment
Orienting and training participants to the Intervention
1. What was your initial impression about an intervention like this? Please explain
2. When you were told that you would receive this intervention for 4 week, how did you feel?
3. In order to use this intervention, do you think that you need
Training Support from caregivers Both Manage yourself
4. Did you receive sufficient information about the intervention before it was handed over to you?
Yes, definitely Yes, to some extent No
5. Were the instructions provided to you to access the intervention from Smartphone clear andunderstandable?
Yes, definitely Yes, to some extent No
6. Do you the think, the demonstration provided to you to access the intervention from Smartphoneclear and understandable?
Yes, definitely Yes, to some extent No
7. Do you think that the instruction booklet was helpful to you to access the intervention fromSmartphone?
Yes, definitely Yes, to some extent No
8. Did you get sufficient opportunity to try accessing the intervention from the smartphone yourself -before it was handed over to you?
Yes, definitely Yes, to some extent No
9. Did you have enough confidence to try out this intervention when it was provided to you?
Yes, definitely Yes, to some extent No
10. Overall do you think you received sufficient training and support to access the intervention from thesmartphone?
Yes, definitely Yes, to some extent No
Accessing the intervention
11. Did you access the intervention videos on the smartphone by yourself? Yes / No
If yes, go to question 12 if no, go to question 14
Study Title: Development of a Smartphone-enabled carer-supported educationalintervention for management of disabilities following stroke in India
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BMJ Open
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12. Was it easy to navigate between the webpages and the intervention videos easily?
Yes, definitely Yes, to some extent No
13. Did you have any difficulty in accessing the intervention videos from smartphone? Yes / No
If yes, please mention the difficulties you experienced.
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
14. Who helped you to watch the intervention videos? ______________________________
15. Was it easy for them to navigate between the webpages and the intervention videos easily?
Yes, definitely Yes, to some extent No
16. Did they have any difficulty in accessing the intervention from smartphone? Yes / No
If yes, please mention the difficulties that they experienced.
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Content of the Intervention
17. Do you think that the video information was presented in a way you could watch and understand?
Yes, Definitely Yes, to some extent No
18. Were the intervention videos relevant to your current needs?
Yes, completely Yes, to some extent No
19. Which section was more interesting?
Stroke information Home-based exercises Assistive devices Functional skills ADL All None
20. Which section was less interesting?
Stroke information Home-based exercises Assistive devices Functional skills ADL All None
Utilisation of the Intervention
21. How do you feel about the length of time from being discharged from hospital to being given thisintervention
The intervention was given to me earlier than I thought was necessary
The intervention was given to me as soon as I thought was necessary
The intervention should have been given to me sooner
The intervention should have been given to me much sooner
Page 52 of 58
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22. How often did you watch the intervention videos in the past four weeks?
Once or more than once daily Once or more than once weekly whenever necessary
Whenever possible
23. Was it only you, who watched the intervention videos? yes / no
24. If no, please mention those who watched the intervention videos
____________________________________________________________________________
25. Do you think that the videos were useful to you?
Yes, completely Yes, to some extent No
26. If yes, in what ways were the videos useful to you? Please explain
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
27. Please mention three things that you liked most about this intervention
_______________________________________________________________________________
28. Please mention three things that you liked least about this intervention
_______________________________________________________________________________
29. Have you seen similar kind of videos before? Yes / No
30. If yes, was there anything new in these videos – please explain?
_______________________________________________________________________________
_______________________________________________________________________________
31. Did you try doing some activities or exercises yourself, after watching from the videos?
Yes, always Yes, sometimes No
32. Do you think, four weeks is sufficient time given to you to use this smartphone intervention?
Yes, definitely yes, probably No, I will need it for some more time
33. Will you use this intervention even after you give the smartphone back? Yes / No
34. If yes, how will you do that? Please explain
_______________________________________________________________________________
35. Overall, Did you like this intervention
Yes, definitely Yes, probably No
36. Do you think this intervention would be useful for someone affected by stroke?
Yes, definitely Yes, probably No
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For peer review only
37. How useful was this intervention?
Extremely useful Very useful Useful to an extent Not useful
38. How would you rate the smartphone-enabled intervention you received?
Excellent Very useful satisfactory Poor
39. Would you recommend this intervention to your friends and family?
Yes, definitely Yes, probably No
40. If no, please comment
________________________________________________________________________________
41. Other Comments / Suggestions
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BMJ Open
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on Septem
ber 21, 2020 by guest. Protected by copyright.
http://bmjopen.bm
j.com/
BM
J Open: first published as 10.1136/bm
jopen-2015-009243 on 2 February 2016. D
ownloaded from
For peer review only
Study Phase – 3: Satisfaction Survey
Assessment form for Caregivers of Individual with Stroke
Participant Study ID: Date of Assessment
Orienting and training participants to the Intervention
1. What was your initial impression about an intervention like this? Please explain
2. When you were told that you would receive this intervention for 4 week, how did you feel?
3. To support the stroke survivor in using this intervention, do you think that you need
Training Support from other caregivers Both Manage yourself
4. Did you receive sufficient information about the intervention before it was handed over to you?
Yes, definitely Yes, to some extent No
5. Were the instructions provided to you to access the intervention from Smartphone clear andunderstandable?
Yes, definitely Yes, to some extent No
6. Do you the think, the demonstration provided to you to access the intervention from Smartphoneclear and understandable?
Yes, definitely Yes, to some extent No
7. Do you think that the instruction booklet was helpful to you to access the intervention fromSmartphone?
Yes, definitely Yes, to some extent No
8. Did you get sufficient opportunity to try accessing the intervention from the smartphone yourself -before it was handed over to you?
Yes, definitely Yes, to some extent No
9. Did you have enough confidence to try out this intervention when it was provided to you?
Yes, definitely Yes, to some extent No
10. Overall do you think you received sufficient training and support to access the intervention from thesmartphone?
Yes, definitely Yes, to some extent No
Accessing the intervention
11. Did you access the intervention videos on the smartphone by yourself? Yes / No
If yes, go to question 12 if no, go to question 14
Study Title: Development of a Smartphone-enabled carer-supported educationalintervention for management of disabilities following stroke in India
Page 55 of 58
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BMJ Open
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on Septem
ber 21, 2020 by guest. Protected by copyright.
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J Open: first published as 10.1136/bm
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ownloaded from
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12. Was it easy to navigate between the webpages and the intervention videos easily?
Yes, definitely Yes, to some extent No
13. Did you have any difficulty in accessing the intervention videos from smartphone? Yes / No
If yes, please mention the difficulties you experienced.
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
14. Who helped you to watch the intervention videos? ______________________________
15. Was it easy for them to navigate between the webpages and the intervention videos easily?
Yes, definitely Yes, to some extent No
16. Did they have any difficulty in accessing the intervention from smartphone? Yes / No
If yes, please mention the difficulties that they experienced.
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Content of the Intervention
17. Do you think that the video information was presented in a way you could watch and understand?
Yes, Definitely Yes, to some extent No
18. Were the intervention videos relevant to the current needs of the stroke survivor?
Yes, completely Yes, to some extent No
19. Which section was more interesting to the stroke survivor?
Stroke information Home-based exercises Assistive devices Functional skills ADL All None
20. Which section was more interesting to you?
Stroke information Home-based exercises Assistive devices Functional skills ADL All None
Utilisation of the Intervention
21. How do you feel about the length of time from being discharged from hospital to being given thisintervention
The intervention was given to us earlier than I thought was necessary
The intervention was given to us as soon as I thought was necessary
The intervention should have been given to us sooner
The intervention should have been given to us much sooner
Page 56 of 58
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BMJ Open
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on Septem
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j.com/
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J Open: first published as 10.1136/bm
jopen-2015-009243 on 2 February 2016. D
ownloaded from
For peer review only
22. How often did the stroke survivor watch the intervention videos in the past four weeks?
Once or more than once daily Once or more than once weekly whenever necessary
Whenever possible
23. Was it only the stroke survivor, who watched the intervention videos? yes / no
24. If no, please mention those who watched the intervention videos
____________________________________________________________________________
25. Do you think that the videos were useful to the stroke survivor?
Yes, completely Yes, to some extent No
26. If yes, in what ways were the videos useful to them? Please explain
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
27. Please mention three things that you liked most about this intervention
_______________________________________________________________________________
28. Please mention three things that you liked least about this intervention
_______________________________________________________________________________
29. Have you seen similar kind of videos before? Yes / No
30. If yes, was there anything new in these videos – please explain?
_______________________________________________________________________________
_______________________________________________________________________________
31. Did the stroke survivor try doing some activities or exercises themselves or with the help of the familyafter watching from the videos?
Yes, always Yes, sometimes No
32. Do you think, four weeks is sufficient time given to the stroke survivor and you to use this smartphoneintervention?
Yes, definitely yes, probably No, I will need it for some more time
33. Will you support the stroke survivor in using this intervention even after you give the smartphoneback? Yes / No
34. If yes, how will you do that? Please explain
_______________________________________________________________________________
35. Overall, Did you like this intervention
Yes, definitely Yes, probably No
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36. Do you think this intervention would be useful for someone affected by stroke?
Yes, definitely Yes, probably No
37. As a caregiver, how useful do you think was this intervention to the stroke survivor?
Extremely useful Very useful Useful to an extent Not useful
38. How would you rate the smartphone-enabled intervention?
Excellent Very useful satisfactory Poor
39. Would you recommend this intervention to your friends and family?
Yes, definitely Yes, probably No
40. If no, please comment
________________________________________________________________________________
41. Other Comments / Suggestions
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on Septem
ber 21, 2020 by guest. Protected by copyright.
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j.com/
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J Open: first published as 10.1136/bm
jopen-2015-009243 on 2 February 2016. D
ownloaded from