Open Access Protocol Effectiveness of a multifactorial of

Effectiveness of a multifactorialintervention on preventing developmentof frailty in pre-frail older people:study protocol for a randomisedcontrolled trial

Nicola Fairhall,1 Susan E Kurrle,2 Catherine Sherrington,3 Stephen R Lord,4

Keri Lockwood,2 Beatrice John,2 Noeline Monaghan,1 Kirsten Howard,5

Ian D Cameron1

To cite: Fairhall N, Kurrle SE,Sherrington C, et al.Effectiveness of amultifactorial intervention onpreventing development offrailty in pre-frail olderpeople: study protocol for arandomised controlled trial.BMJ Open 2015;5:e007091.doi:10.1136/bmjopen-2014-007091

▸ Prepublication history andadditional material isavailable. To view please visitthe journal (http://dx.doi.org/10.1136/bmjopen-2014-007091).

Received 3 November 2014Revised 8 January 2015Accepted 12 January 2015

For numbered affiliations seeend of article.

Correspondence toProfessor Ian D Cameron;[email protected]

ABSTRACTIntroduction: Frailty is a major concern due to itscostly and widespread consequences, yet evidence ofeffective interventions to delay or reduce frailty islacking. Our previous study found that a multifactorialintervention was feasible and effective in reducingfrailty in older people who were already frail. Identifyingand treating people in the pre-frail state may be aneffective means to prevent or delay frailty. This studydescribes a randomised controlled trial that aims toevaluate the effectiveness of a multifactorialintervention on development of frailty in older peoplewho are pre-frail.Methods and analysis: A single centre randomisedcontrolled trial with concealed allocation, assessorblinding and intention-to-treat analysis. Two hundredand thirty people aged above 70 who meet theCardiovascular Health Study frailty criteria for pre-frailty, reside in the community and are without severecognitive impairment will be recruited. Participantswill be randomised to receive a multifactorialintervention or usual care. The intervention group willreceive a 12-month interdisciplinary interventiontargeting identified characteristics of frailty andproblems identified during geriatric assessment.Participants will be followed for a 12-month period.Primary outcome measures will be degree of frailtymeasured by the number of Cardiovascular HealthStudy frailty criteria present, and mobility measuredwith the Short Physical Performance Battery.Secondary outcomes will include measures ofmobility, mood and use of health and communityservices.Ethics and dissemination: The study wasapproved by the Northern Sydney Local Health DistrictHealth Research Ethics Committee (1207-213M). Thefindings will be disseminated through scientific andprofessional conferences, and in peer-reviewedjournals.Trial registration number: Australian New ZealandClinical Trials Registry: ACTRN12613000043730.

INTRODUCTIONIntervention to prevent or delay frailty hasimportant benefits for older people, healthservices and society.1 2 Frailty is a medicalsyndrome with numerous causes, charac-terised by reduced strength, endurance andphysiological function, resulting in increasedvulnerability to functional decline, depend-ence and/or death.1 Pre-frailty is an inter-mediate stage between non-frail and frail.Identifying and treating people in thepre-frail state may be an effective way toprevent or delay frailty.Frailty can be defined using the

Cardiovascular Health Study (CHS) frailtyphenotype3 which contains five criteria(unexplained weight loss, weakness, low activ-ity, exhaustion and slowness) that reflectunderlying dysregulation in multiple physio-logical processes.4 People are classified as

Strengths and limitations of this study

▪ First randomised controlled trial to evaluate theeffectiveness of an intervention on the develop-ment of frailty in older people who are pre-frail.

▪ Randomised controlled trial with blinded asses-sors and intention-to-treat analysis.

▪ Generalisable to community-dwelling pre-frailolder people; there is an objective measure ofpre-frailty and minimal exclusion criteria. Theintervention being examined is readily transfer-able to routine clinical practice in the aged carehealth service setting and the interdisciplinaryapproach is relevant to several professionalgroups in aged care.

▪ Lack of blinding of participants and staff deliver-ing the intervention due to the nature of theintervention.

Fairhall N, et al. BMJ Open 2015;5:e007091. doi:10.1136/bmjopen-2014-007091 1

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non-frail if they meet no criteria, pre-frail if they meetone or two criteria, and frail if they meet three or morecriteria. The frailty phenotype is predictive of falls, dis-ability, institutionalisation, hospitalisation and mortality;pre-frail individuals have a significantly higher risk ofdeveloping these adverse outcomes than non-frailpeople, and frail individuals have a still higher risk.3

Pre-frailty and frailty are common; a recent systematicreview found that the prevalence of pre-frailty (asdefined by the frailty phenotype) in community-dwellingpeople aged 65 years or older was 38–53% (mean44.2%), and the prevalence of frailty was 4–17% (mean9.9%).5 As the proportion of older people is risingglobally, the costs associated with frailty will increase inthe future. Preventing or delaying frailty has the poten-tial to reduce the burden on individuals and society.Research into interventions to prevent or reduce

frailty is in its infancy. While studies have found that out-comes for frail older people can be improved usingmultifactorial interventions such as comprehensive geri-atric assessment, and single interventions including exer-cise programmes,6 nutritional supplementation andreduction of polypharmacy,1 the effect of interventionon frailty itself is seldom examined. Our recent rando-mised trial evaluated the effect of a multifactorial inter-disciplinary intervention on frailty as a primary outcome(measured using the frailty phenotype), and found thatthe intervention significantly reduced frailty in frailcommunity-dwelling older people.7

Implementing interventions for pre-frail older peoplemay prevent the development of frailty. Older peopletransition between frailty states,8 and pre-frail individualshave more than twice the risk of becoming frail com-pared with non-frail people.3 Transition from pre-frail tofrail often ensues from an acute medical event or a psy-chological stress exceeding the person’s capacity forrecovery.9 Intervention to increase reserve capacity andreduce the impact of potential stressors may thereforereduce the risk of becoming frail. Evidence suggests thatpre-frail older people may respond better to interven-tion than people who have already moved to a frailstate,10 11 and because pre-frail people have significantlyless disability than frail people3 there is potential formore intensive interventions.Few trials have identified and targeted pre-frail partici-

pants. Previous trials have included samples that are prob-ably pre-frail, for example people at risk of falling;12

however, studies need to have pre-frailty as an inclusioncriterion for results to be generalisable to this population.Recent randomised trials10 13 14 and an observationalstudy15 have investigated the effects of exercise in peopledefined as pre-frail using the frailty phenotype; exerciseappears to improve function in pre-frail people; however,larger studies are needed. To the best of our knowledge,no intervention has been developed to specificallyprevent the transition to frailty in pre-frail older people.We plan to conduct the Pre-Frailty Intervention Trial

(Pre-FIT), a randomised controlled trial that aims to

determine whether delivering a multifactorial, interdis-ciplinary intervention to older people who are pre-frailprevents progression to frailty and improves mobility. Wewill implement a modification of the intervention previ-ously found to reduce frailty and improve mobility infrail older people16 to determine whether pre-frail parti-cipants receive similar benefits with respect to frailtylevels and mobility. To the best of our knowledge, thiswill be the first study to examine the effects of an inter-vention specifically targeting the degree of frailty amongolder people who are pre-frail. The primary researchquestion is: Does the multifactorial interdisciplinaryintervention prevent the progression to frailty (assessedwith a frailty phenotype score) and improve mobilityamong pre-frail older people, when compared withusual care?

METHODS AND DESIGNDesignA randomised controlled trial will be conducted among230 participants who are pre-frail. Figure 1 gives an over-view of the study design. All participants will give writteninformed consent prior to randomisation (see onlinesupplementary appendix 1). The study is registered withthe Australia New Zealand Clinical Trials RegisterACTRN12613000043730.

ParticipantsPotential participants will be identified by cliniciansworking in hospital and community sections of theDivision of Rehabilitation and Aged Care Services(DRACS) at Hornsby Ku-ring-gai Health Service, Sydney,Australia.Participants who fulfil the following inclusion criteria

will be invited to participate:1. Man or woman aged 70 years or older;2. Meet one or two CHS frailty criteria,3 and thus are

considered pre-frail (table 1);3. Mild or no cognitive impairment (defined as a

Mini-Mental State Examination score >23).People will be ineligible to participate in the trial if

they:1. Live in a residential aged care facility;2. Have an estimated life expectancy of less than

12 months (estimated by a score of ≤3 on a modifiedversion of the Implicit Illness Severity Scale17);

3. Currently receive a treatment programme from arehabilitation facility.

RandomisationAfter consent and completion of the baseline assess-ment, participants will be entered into the study andrandomised to intervention or control groups. Permutedblock randomisation will be used,18 with a randomnumber sequence generated by SPSS V.19 and variableblock sizes of four and six randomly arranged withinblocks of 10. Project personnel not otherwise involved in

2 Fairhall N, et al. BMJ Open 2015;5:e007091. doi:10.1136/bmjopen-2014-007091

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recruitment or data collection will manage randomgroup allocation. The treatment allocation tables will bestored away from the research office.

Allocation concealmentThe research consultant will screen for study eligibility,seek informed consent and conduct the baseline assess-ment. After baseline assessment is completed, theResearch Consultant will telephone the central studyoffice, and the participant will be assigned a participantnumber and allocated to the control or intervention

group. Staff performing the outcome assessment anddata analysis will be blinded to group allocation;however, owing to the nature of the trial, it is not pos-sible to blind the participants and staff administeringinterventions.

InterventionParticipants assigned to the control group will receivethe usual care available to older residents of HornsbyKu-ring-gai area from their general practitioner andcommunity services. At the study site, usual care for non-

Figure 1 Overview of the flow of

participants through the Pre-frailty

Intervention Trial.

Table 1 Definition of Frailty Components, adapted from Cardiovascular Health Study Criteria3

Characteristic Criteria

Weight loss/

shrinking

Self-report of ≥4.5 kg lost unintentionally in the previous 12 months or loss of ≥5% of weight in the prior

year by direct measurement of weight

Weakness Lowest 20% in grip strength, measured using a dynamometer (Saehen Dynamometer, model SH5001).

Best of three attempts used. Men scoring 30 kg or less, women scoring 18 kg or less meet the criteria

Exhaustion Answering ‘a moderate amount’ or ‘most of the time’ to either of the 2 questions from the Centre for

Epidemiological Studies-Depression Scale (CES-D) indicated exhaustion: “How often did you feel that

everything you did was an effort in the last week?” or “How often did you feel that you could not get

going in the last week?”

Slowness Time to walk 4 m, with or without a walking aid, equals 6 s or more

Low activity In the past 3 months, weight bearing physical activity was not performed, more than 4 h per day were

spent sitting, and went for a short walk once per month or less


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institutionalised pre-frail older people involves medicalmanagement of health conditions, allied health input,assessment of care needs and provision of care.Participants in the intervention group will receive an

interdisciplinary, multifactorial intervention for 1 year.The intervention will be individually tailored to eachparticipant based on the following: (A) the CHS frailtycharacteristics present at baseline assessment; (B) add-itional problems identified during a detailed assessmentby the physiotherapist providing the intervention pro-gramme, plus other relevant members of the interdiscip-linary team; (C) ongoing reassessment by theinterdisciplinary team throughout the interventionperiod. The assessment and intervention will be under-pinned by the principles of geriatric evaluation andmanagement.19 20 An interdisciplinary team comprisinga physiotherapist, a geriatrician, a rehabilitation phys-ician, a dietician and a nurse will deliver the interven-tion. All intervention staff will have experience indelivering interventions to older people. Case manage-ment and regular case conferences will assist coordin-ation of the interdisciplinary delivery of theintervention. The treating physiotherapist will have therole as case coordinator, liaising with the participant,family, health professionals and service providers, pluscoordinating services as indicated.The intervention will be delivered primarily in partici-

pants’ homes, with additional community exercise pro-grammes and outpatient appointments (eg, podiatrist,memory clinic, continence clinic) offered whenindicated.The interventions targeting the CHS frailty character-

istics are described below.

Weight lossA dietician will evaluate nutritional intake if the partici-pant is not already effectively addressing their recentweight loss. If the participant’s body mass index is<18.5 kg/m2 or mid-upper arm circumference <10thcentile (using Australian gender-specific and age-specificnorms), nutritional supplementation will be offeredusing commercially available, high-protein, high-energysupplements. Home delivered meals will be recom-mended if appropriate clinical criteria apply.

ExhaustionReferral to a psychiatrist or psychologist will be consid-ered if the Geriatric Depression Scale score is high.Where the participant is socially isolated, opportunitiesto encourage greater social engagement will be identi-fied, for example, day activity groups, physical activityprogrammes in the community and telephone contactwith volunteers.

Grip weakness, slow 4 m walk time or low physical activity levelA physiotherapist experienced in aged care will visit theparticipant’s home 10 times in the 12-month studyperiod. There will be five sessions in the first 3 months

after randomisation, and five sessions over the following9 months. Visits will be of 60–120 min duration. Thephysiotherapist will prescribe a home exercise pro-gramme to be performed for 20–30 min, up to six timesper week, for 12 months. The exercises, degree of diffi-culty and number of repetitions prescribed will be basedon assessment of the individual participant’s abilities.Lower limb balance and strengthening exercises willutilise the Weight Bearing Exercise for Better Balance(WEBB) programme, available at http://www.webb.org.au.21 The programme targets strength and control ofthe lower limb extensor muscles (hip and knee exten-sors, ankle plantarflexors) with exercises includingstanding up from a chair, forward and lateral step-upsonto a block and heel raises while standing on a wedge.Resistance will be applied by body weight or by weightedvests or weight-belts as appropriate. Balance will be tar-geted with exercises performed while standing on a pro-gressively narrowed base (feet together, tandem stance,single leg stance), stepping, walking and reaching.Upper limb support will be minimised in order toadequately challenge balance, but to ensure safety theenvironment will be set up with stable supports (eg,bench or table) close by that can be held as necessary.In addition, if upper limb weakness is creating func-tional problems, then the physiotherapist may prescribeupper limb exercises incorporating theraband or freeweights for resistance. The physiotherapist will regularlyreview and modify the optimal intensity and type of exer-cises for each participant to ensure that the interventionremains appropriate and challenging over the studyperiod. We will encourage family members or carers toassist with the exercise programme when this isindicated.Appropriate safe mobility programmes will be pre-

scribed if participants have low activity levels, reducedendurance or specific functional goals. Feedback will beprovided via monitoring of distance/time or via a pedom-eter or FitBit (internet-linked pedometer). Participantswill be encouraged and supported in increasing theirphysical activity using exercise equipment that they haveat home, as well as community physical activity pro-grammes (such as Tai Chi or strength and balanceclasses), community exercise facilities (such as gymna-siums and swimming pools) and a return to past leisureactivities such as golf and bowls.In addition to the interventions targeting the CHS

frailty characteristics, individually tailored interventionwill address additional problems identified during assess-ment. Intervention may include, but will not be limitedto, the following examples.▸ General health status will be assessed and interven-

tion tailored to each individual’s problems. Whereindicated, chronic disease management programmeswill be implemented or reinforced in conjunctionwith existing health services. We will use the princi-ples of comprehensive geriatric assessment, withcareful follow-up of chronic diseases, pain and


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conditions such as incontinence, osteoporosis andimpaired cognition. The rehabilitation physician andgeriatrician will play a central role in assessment andrecommendations for ongoing intervention.

▸ The rehabilitation physician or geriatrician will reviewmedications used and discuss any questionable medi-cation use with the participant’s general practitioner.Poor compliance with medications will be addressedby initiation or reinforcement of strategies such aseducation about medications, medication packagingin blister packs and reminder cards.

▸ Referrals will be made as indicated to allied health,Hearing Australia, Vision Australia, and disease-specific programmes such as pulmonary rehabilita-tion, cardiac rehabilitation and Parkinson’s diseaseexercise classes.

▸ The team will refer to agencies that provide assess-ments and provision of care and services. Examplesare the Aged Care Assessment Team for assessment ofpackages of care, community nursing and serviceproviders.

▸ If transport is required, we will arrange referral tocommunity transport services, taxi subsidy schemesand mobility parking schemes as appropriate.

▸ Reduced social interaction will be targeted by facilitat-ing attendance at community-based groups, daycentres, clubs and exercise groups, as well as by arran-ging telephone contact with a volunteer.

▸ We will advise on meal delivery services and frozenmeals if this assistance is needed.

▸ Mobility aids and other equipment will be recom-mended, obtained and set up where indicated. Thismay involve referral to an occupational therapist forenvironmental modifications.

▸ Advice on appropriate footwear will be provided ifshoes are suboptimal.

▸ Ergonomic alterations will be made to optimise homeoffice safety.

▸ If the participant is at risk of falling, they may bereferred to falls-specific clinics (Falls andOsteoporosis Clinics) and programmes (Stepping Onprogram, Otago Exercise Program) available in thestudy area, in addition to the WEBB exercise pro-gramme. Safety concerns will also be addressed withinformation about falls prevention, personal alarmsand hip protectors.

▸ If the participant cares for another person or the par-ticipant has a carer who needs help, the carer’s needswill be assessed and contact with Carers Australia willbe suggested.The physiotherapist and participant will collaborate to

set measurable goals within 3 months of recruitment.The goals will be based on the CHS frailty characteristicspresent (such as goals relating to diet, functional conse-quences of weakness or amount of physical activity), orproblems identified during geriatric assessment (such asestablishing formal links with a diabetes educator, under-standing medications or obtaining a care package).

The goals will be documented, reviewed each session bythe physiotherapist and participant, and new goals willbe set when new issues are targeted.The physiotherapist will promote adherence to the

intervention using strategies including goal setting, aflexible time frame for intervention delivery, recordingof exercise completion, and involvement of family andcarers. In addition, programmes will be tailored to suitindividual requirements and interventions will bedesigned to be varied, sustainable and enjoyable.

Data collectionParticipants will undergo three home-based assessments.The baseline measures will be assessed prior to random-isation and further assessments will be conducted 4 and12 months after randomisation. Additional healthservice utilisation data will be collected via a telephonecall at 8 months. Blinded assessors (experienced healthprofessionals) will conduct follow-up assessments. Toensure blinding, participants will be instructed not todisclose group allocation to the assessors. The assessors’perception of group allocation will be assessed to evalu-ate the success of assessor blinding.

Outcome measuresDemographic and health information will be collectedat baseline. Cognitive function will be assessed with theMini-Mental State Examination.22

Primary outcomesThe primary outcomes measured are frailty and mobility,measured at 4 and 12 months. Frailty will be measuredusing the CHS frailty phenotype3 as detailed in table 1.The frailty phenotype evaluates five components of thefrailty syndrome and allocates one point for each criter-ion met; participants meeting zero criteria are definedas non-frail, whereas those meeting one or two criteriaare defined as pre-frail, and those meeting three, fouror five criteria are defined as frail. Mobility will beassessed using the lower extremity continuous summaryperformance score (CSPS),23 with data collected usingthe Short Physical Performance Battery (SPPB).24 Thisbattery examines the ability to stand (for 10 s) with thefeet together in the side-by-side, semi-tandem andtandem positions, time taken to walk 4 m, and time torise from a chair and return to the seated position fivetimes.

Secondary outcomes1. Psychological status will be assessed using the

five-item version of the Geriatric Depression Scale.25

2. Activities of daily living will be measured using theBarthel Index26 (100 point version). The mobilitycomponent of the Activity Measure for Post AcuteCare27 will measure self-reported activity level usingItem Response Theory and computer-adaptivetesting.

3. Gait speed will be measured using the 4 m walk test.


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4. The EQ-5D (EuroQol) will measure health-relatedquality of life and provide utility weights to allow cal-culation of quality adjusted life years (QALYs) for usein the economic evaluation.28

5. Falls, hospitalisations and admissions to residentialaged care facilities will be collected via telephone at4, 8 and 12 months and will also be used in the eco-nomic analyses.

6. Health and community service use will be recordedat 4, 8 and 12 months and will be used in economicanalyses.

Additional measuresAdherence measurements will record the acceptance ofhealth and other services by the study participant. Thetreating physiotherapist will estimate a global level ofadherence (in five categories: 0%, <25%, 25–49%,50–74% and ≥75%) during the 12-month intervention.The treating physiotherapist will evaluate goal attain-ment in the intervention group using a four-point scale:deterioration from baseline ability, maintained baselineability, goal met, goal exceeded.Adverse events will be defined as medical events or

injuries arising as a consequence of the trial and resultingin medical attention or restricted activities of daily livingfor more than 2 days.29 Deaths will be documented.

Sample size calculationAn a priori power analysis determined that 230 partici-pants will need to be recruited to provide 80% power todetect a clinically and statistically significant 15%between-group difference in the lower extremity CSPS(SD=0.7).24 This sample size will also provide sufficientpower to detect a clinically meaningful 20% between-group difference in the transition to frailty. For thesecalculations, we assumed an α of 0.05, a non-complianceof 15% and a dropout rate of 15%.

Statistical analysisFrailty will be treated as a dichotomous variable, scoredas transitioned to frailty (ie, the number of frailty criteriawas 3 or more) or did not transition to frailty (numberof frailty criteria was 0, 1 or 2). The χ2 test will be usedfor frailty as a dichotomous variable. The other studyoutcomes will be treated as continuous variables. Theeffect of group allocation on continuously scoredoutcome measures at the 4-month and 12-month follow-ups will be analysed using linear regression models withbaseline scores entered into the linear regressionmodels as covariates. To aid interpretation of the changein frailty, frailty will also be reported as a continuousvariable. Statistical significance will be set at p<0.05 andwe will report the differences in percentage or mean(95% CI) between the two groups at the 4-month and12-month follow-ups.We will test whether the response to the intervention

is modified by the number of frailty criteria present atbaseline, by including an interaction term of study

groups with the number of frailty criteria at baseline inthe regression analyses.30 Secondary analyses will alsoexplore the effect of different rates of adherence (as acategory variable: <25%, 25–49%, 50–74% and ≥75%)on the outcomes in the intervention group at 12-monthfollow-up. We will examine baseline variables and ifthere are important between-group differences, we willadjust for them in the models. The primary analyses willbe conducted in accordance with the intention-to-treatprinciple.31 Data will be coded to permit blinding togroup allocation in the statistical analysis.Participants will be provided with their own results on

request. The overall results will be available to partici-pants once the final results are published. It is antici-pated that participants will register their interest inreceiving this information when their participation inthe study ends.

Economic evaluationThe economic evaluation will be carried out andreported in accordance with health economics reportingstandards.32 The economic evaluation will take the per-spective of Australian health and aged care service provi-ders over a 12-month time period. Benefits will bemeasured in terms of the number of transitions to frailtyprevented, mobility improvement and QALYs gained(based on utility weights derived from the EQ-5D). Thecost-effectiveness analyses will include the cost of deliver-ing the intervention and the cost of health and commu-nity service utilisation. Bootstrap sampling will be usedto examine the joint probability distribution of costs andoutcomes, with the creation of incremental cost-effectiveness planes and cost-effectiveness acceptabilitycurves for each outcome.

Time frameRecruitment started in January 2013. Follow-up assess-ment is expected to conclude in October 2015.

DISCUSSIONThis trial will provide important information to guideintervention to improve outcomes for older people whoare pre-frail. Specifically, it will determine whether amultifactorial interdisciplinary intervention reduces tran-sition to frailty and deterioration in mobility amongpre-frail older men and women who live in the commu-nity. Frailty and the associated negative effects such asdisability, institutionalisation and hospitalisation arecostly to individuals, their families, the health systemand society. Despite this cost, to the best of our knowl-edge, there has been no research to date examining theeffectiveness of an intervention designed to reduce thetransition to frailty among pre-frail older people.The proposed multifactorial intervention will target

the needs of each participant based on the characteristicsof frailty present and comprehensive geriatric assessment.The exercise component was designed using evidence


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from systematic reviews and randomised trials that havedemonstrated improved strength, balance and mobility inolder people. We will implement strategies to maximiseadherence to the intervention, in line with research sug-gesting that good patient adherence increases the effect-iveness of health interventions.7 33 The intervention isbased on the programme that was feasibly delivered tofrail older people in the Frailty Intervention Trial,16 withsome modifications to enable a greater challenge tobalance, strength and physical activity. Tailoring the exer-cises to the individual and ongoing reassessment by thetreating physiotherapist will ensure safety.Additional strengths of the study are the generalisabil-

ity to pre-frail older people and aged care health servicesettings, and the robust, but pragmatic, clinical trialdesign. This study uses an objective measure of pre-frailty; the CHS criteria have previously been used torecruit frail7 and pre-frail13–15 people to clinical trials.We have avoided excessive exclusion criteria. The inter-vention being examined is readily transferable toroutine clinical practice in the aged care health servicesetting and the interdisciplinary approach is relevant toseveral professional groups in aged care.This study has some limitations. First, participants

cannot be blinded to group allocation, which is a poten-tial source of bias due to possible differential reportingof the weight loss, activity and exhaustion frailty criteria.However, the weakness and slowness frailty criteria andthe co-primary outcome measure (CSPS) are perform-ance based, which should reduce this bias. Second, asthere is no frequency-matched social intervention forthe control group, we will not be able to exclude theimpact of social aspects of the programme on any differ-ence between groups. Third, there is no consensus onhow to identify pre-frailty34 and while the CHS pheno-type is the most widely accepted instrument, other vali-dated tools35 and attention to cognition could beconsidered in the clinical setting.If this intervention is shown to be effective, there are

major potential benefits to the older population interms of preventing transition to frailty and improvingmobility. Avoiding frailty has the potential to reduceadverse health outcomes, such as fall rates, hospitalisa-tion and institutionalisation, and the associated financialcosts. Improved mobility may also result in improvedfunction and better quality of life for older people, theirfamilies and carers. If cost-effectiveness is demonstrated,this intervention will lead to more efficient utilisation ofhealth services. The findings will be disseminatedthrough scientific and professional conferences and inpeer-reviewed journals.

Author affiliations1Rehabilitation Studies Unit, Sydney Medical School, The University ofSydney, Sydney, New South Wales, Australia2Division of Rehabilitation and Aged Care, Hornsby Ku-ring-gai HealthService, Hornsby, New South Wales, Australia3The George Institute for International Health, Sydney Medical School, TheUniversity of Sydney, Sydney, New South Wales, Australia

4Neuroscience Research Australia, University of New South Wales, Sydney,New South Wales, Australia5School of Public Health, Sydney Medical School, The University of Sydney,Sydney, New South Wales, Australia

Acknowledgements This study was supported by the Doris Whiting SpecialPurpose and Trust Fund, administered by the Division of Rehabilitation andAged Care, Hornsby Ku-ring-gai Health Service, Australia.

Contributors NF drafted the manuscript. CS, SRL, SEK and IDC are chiefinvestigators on the study. NF, KL, NM, BJ and KH are actively involved in thestudy. All authors read and approved the final manuscript.

Funding IDC’s salary is supported by an Australian National Health andMedical Research Council Practitioner Fellowship

Competing interests None.

Ethics approval The Northern Sydney Local Health District Health ResearchEthics Committee approved this study (Research Protocol Number1207-213M).

Provenance and peer review Not commissioned; externally peer reviewed.

Open Access This is an Open Access article distributed in accordance withthe Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, providedthe original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Pre-frail Intervention Trial 09 August 2012 Version 2

Pre-FIT: A multifactorial interdisciplinary treatment program for older people who are pre-frail

Invitation You are invited to participate in a research study investigating the effectiveness of a specialised treatment program for older people who are pre-frail. The study is being conducted by Hornsby Ku-ring-gai Hospital and the Rehabilitation Studies Unit (University of Sydney).

Before you decide whether or not you wish to participate in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish.

1. What is the purpose of this study? The purpose is to investigate whether or not a program involving contact with one or several health professionals over a period of approximately 12 months is effective in improving the overall health of people who are pre-frail. The study definition of pre-frail requires that participants have one or two criteria that have been linked to frailty in a previous study (The Cardiovascular Health Study). These criteria are: 1. Unexplained weight loss in the past year. 2. Diminished grip strength. 3. Self reported exhaustion. 4. Sow gait speed and 5. low energy expenditure. 2. Why have I been invited to participate in this study? You are eligible to participate in this study because you are aged over 70 years, and may meet our definition of being pre-frail.

3. What if I don’t want to take part in this study or if I want to withdraw later? Participation in this study is voluntary. It is completely up to you whether or not you participate. If you decide not to participate, it will not affect any treatment you receive now or in the future. Whatever your decision, it will not affect any future relationship with Hornsby Hospital or The University of Sydney. New information about the treatment being studied may become available during the course of the study. You will be kept informed of any significant new findings that may affect your willingness to continue in the study.

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If you wish to withdraw from the study once it has started, you can do so at any time without having to give a reason.

4. What are the alternatives to participating in this study? If you decide not to participate in this study, you will still receive the standard treatment and care as would otherwise normally have been available to you in this area, generally accessible following consultation with your general practitioner.

5. What does this study involve? If you agree to participate in this study, you will be asked to sign the Participant Consent Form attached to this information sheet. This study will be conducted over a period of 12 months.

This project is a randomised trial. If you agree to participate you will be put into one of two groups. One group will receive the multifactorial intervention while the other group will receive the ‘usual care’ that would otherwise have been available to them. Both groups will receive visits from our research team over a12 month period. The results will be compared to see whether one treatment is more effective than the other. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, like the flip of a coin. Neither the researcher nor the study participant can decide which group the participant will be allocated to. You will be told which group you are in. All participants will be asked to complete three assessments with a study research nurse. One assessment is conducted at the commencement of the study, one after four months and the final assessment at the end of your involvement with the study (at 12 months). These assessments involve some minor strength and balance testing and some questions about your health, well being and service usage.

In addition, the researchers may require access to your hospital medical records in order to obtain information relevant to the study. 6. How is this study being paid for? The study is being sponsored by a trust fund connected to the Rehabilitation and Aged Care Service at Hornsby Ku-ring-gai Hospital. No money (besides normal salary) is paid directly to any individual researchers.

7. Are there risks to me in taking part in this study? All medical procedures involve some risk of injury. In addition, there may be risks associated with this study that are presently unknown or unforeseeable. In spite of all reasonable precautions, it is possible you could develop a medical complication from participating in this study. Based on our experience there is a small risk that a

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musculoskeletal symptom may develop as a result of the physical therapy intervention. This could be in the form of a muscular strain, or minor stress to ligaments or joint. In this unlikely event, the exercise program will be modified. There is also a slight risk of falling while exercising and this possibility will also be monitored.

8. What happens if I suffer injury or complications as a result of the study? If you suffer any injuries or complications as a result of this study, you should contact the researcher visiting you as soon as possible, who will assist you in arranging appropriate medical treatment.

You may have a right to take legal action to obtain compensation for any injuries or complications resulting from the study. Compensation may be available if your

injury or complication is caused by the project intervention or by the negligence of any of the research staff who visit you. If you receive compensation that includes an amount for medical expenses, you will be required to pay for your medical treatment from those compensation monies. If you are not eligible for compensation for your injury or complication under the law, but are eligible for Medicare, then you can receive any medical treatment required for your injury or complication free of charge as a public patient in any Australian public hospital.

9. Will I benefit from the study? This study aims to further develop medical knowledge and may improve future treatment of frailty; it may or may not be of direct benefit you.

10. Will taking part in this study cost me anything, and will I be paid? Participation in this study will not cost you anything; neither will you be paid for your participation.

11. How will my confidentiality be protected? Any identifiable information that is collected about you in connection with this study will remain confidential and will be disclosed only with your permission, or as required by law. Only the study researchers will have access to your details and results and all information will be held securely at Hornsby Ku-ring-gai Hospital.

12. What happens with the results? If you give us your permission by signing the consent document, we plan to publish the results of the study in peer reviewed journals at the conclusion of the trial. In any publication, information will be provided in such a way that you cannot be identified. Results of the study will be provided to you, if you wish.

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13. What happens to my treatment when the study is finished? If you are allocated to the group receiving the intervention, these visits will cease at the end of the study period. Usual community care, assessable through your general practitioner will resume at this point. 14. What should I do if I want to discuss this study further before I decide? When you have read this information, the research nurse will discuss it with you and address any queries you may have. If you would like to know more at any stage, please do not hesitate to contact her or any member of the project team.

15. Who should I contact if I have concerns about the conduct of this study? This study has been approved by the Northern Sydney Coast Human Research ethics Committee of Northern Sydney and Central Coast Local Health Districts (NSLHD & CCLHD). Any person with concerns or complaints about the conduct of this study should contact Professor Ian Cameron at the Rehabilitation Studies Unit on (02) 9808-9236 or alternatively the Research Office on (02) 9926 8106 and quote “ The Pre-frailty Intervention Trial” (Pre-FIT).

Thank you for taking the time to consider this study.

If you wish to take part in it, please sign the attached consent form. This information sheet is for you to keep.

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1. I,.................................................................................................................

of................................................................................................................ ……………………………………………………………………………………

agree to participate as a subject in the study described in the attached participant information statement : Pre-FIT: A multifactorial interdisciplinary treatment program for older people who are pre-frail.

2. I acknowledge that I have read the participant information statement, which

explains why I have been selected, the aims of the study and the nature and the possible risks of the investigation, and the statement has been explained to me to my satisfaction.

3. Before signing this consent form, I have been given the opportunity of asking any

questions relating to any possible physical and mental harm I might suffer as a result of my participation and I have received satisfactory answers.

4. I understand that I can withdraw from the study at any time without prejudice to

my relationship to the University of Sydney or Hornsby Ku-ring-gai Hospital Health Service.

5. I agree that research data gathered from the results of the study may be

published, provided that I cannot be identified. 6. I understand that if I have any questions relating to my participation in this

research, I may contact Professor Ian Cameron on telephone (02) 9808-9236 who will be happy to answer them.

7. I give my consent for my hospital records to be accessed for the purposes of

this research if necessary.

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8. I acknowledge receipt of a copy of this Consent Form and the Participant

Information Statement. I understand that should I have a complaint in regards to the conduct of this trial it may be directed to either Professor Ian Cameron on telephone (02) 9808-9236 or the Northern Sydney Coast Human Research Ethics Committee on (02) 9926 8106. Signature of subject Please PRINT name Date

Signature of Researcher Please PRINT name Date _______________________________________________________________

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Hornby Ku-ring-gai Health Service


REVOCATION OF CONSENT I hereby wish to WITHDRAW my consent to participate in the study described above and understand that such withdrawal WILL NOT jeopardise any treatment or my relationship with the University of Sydney or Hornsby Ku-ring-gai Hospital Signature…………………………….…………..…. Date…../…../….. Please PRINT Name:…………………………………………………………………

Documents

Open Access Protocol Effectiveness of a multifactorial of