Word Count tables: 7,971 - Lippincott Williams & Wilkinsdownload.lww.com/.../AJGP/A/AJGP_2011_07_07_BROD… · Web viewFollow-up Number Method of randomization Blinding of raters

Supplemental Digital Content 1 - Exercise

Study Interventions Study design.Follow-up

Number Method of randomization

Blinding of raters

Outcomes relevant to apathy

Significance Quality

rating

Cevasco and Grant, 2003, USA (1) (See SDC 2 for music component of this study)

Exercise-to-movement activity consisting of combinations ofcontinuous cueing vs single cueing and difficult condition (i.e., participating in designated movement) vs easy condition (approximating the movement) during 38 weekly or twice weekly 50 min sessions over 8 months

Interrupted time series without parallel control group.No f/u

14 assisted living residents with early to middle AD (10 females)

Order of movement activities randomized. Method not stated. Participants served as their own controls.

No Responsiveness and participation in structured, designated movement or approximating the movement or not participating recorded at 30 sec intervals by trained data collectors.

Continuous cueing/easy condition resulted in significantly higher participation than the single cueing/difficult condition (F(3,52) = 2.98, p < .05).

6

Cott et al, 2002, Canada (2)

Walk-and-talk sessions, i.e., conversation while walking in pairs vs talk-only sessions, i.e., conversation while sitting in pairs; both groups’ sessions for 30 min, 5 x weekly for 16 weeks vs usual program

Clustered RCT.No f/u

86 ITT and 74 IA residents with AD in 3 geriatric long-term care facilities (39 females)

Residents randomly assigned to group within each site with random number table. No further details of allocation provided.

Raters blinded to group membership but not study design

Engagement, helping behavior and relationships with others as measured by the disengagement subscale of the London Psychogeriatric Rating Scale (3, 4); social communication and overall communication as measured by the Functional Assessment of Communication Skills for Adults (5)

No significant between-groups differences found on outcome measures at posttest for walk-and-talk sessions. Group and level of cognitive impairment examined as between-subject factors. Main effect for group not significant but main effect for cognitive impairment significant for communication in those with moderate impairment (F(1,68) = 44.65, p = .00). Group x cognitive impairment interaction not significant.

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1

Hopman-Rock et al, 1999, Netherlands (6)

PAP vsusual activities twice weekly over 6 months (min 15 sessions for inclusion)

Pseudo- RCT.No f/u

134 ITT NH residents with dementia from 11 homes for the elderly 92 IA, experimental group n=45 (41 females), control group n=47 (46 females)

Where possible randomly allocated within NH but where not possible, NH group randomly allocated as a whole. Method not stated. Participants also served as their own controls.

No Non-social and apathetic behaviors as measured by these subscales of the BIP (also known as GIP) (7) as well as positive and negative group behaviors as measured by these subscales of the SIPO (6)

Nonsignificant improvement demonstrated in non-social and apathetic behaviors as well as positive and negative group behaviors for PAP group. When group results were separated by level of cognitive impairment, those with higher cognitive performance (Cognitive Screening Test-20 >6) (8) showed a significant increase in positive group behaviors on the SIPO (F = 4.46, p = ≤ .05).

9

Notes: f/u: follow up; AD: Alzheimer’s disease; RCT: randomized controlled trial; ITT: intention to treat; IA: in analysis; PAP: Psychomotor Activation Program; NH: nursing home; GIP/BIP: Gedragsobservatieschaal voor de Intramurale Psychogeriatrie [Dutch Behavior Rating Scale for Psychogeriatric Inpatients]; SIPO: Social Interaction Scale for Psychogeriatric Older People

2

References

1. Cevasco AM, Grant RE: Comparison of different methods for eliciting exercise-to-music for clients with Alzheimer's disease. J Music

Ther 2003; 40:41-56

2. Cott CA, Dawson P, Sidani S, et al: The effects of a walking/talking program on communication, ambulation, and functional status in

residents with Alzheimer disease. Alzheimer Dis Assoc Disord 2002; 16:81-87

3. Reid DW, Tierney MC, Zorzitto ML, et al: On the clinical value of the London Psychogeriatric Rating Scale. J Am Geriatr Soc. 1991;

39:368-371

4. Hersch EL, Kral VA, Palmer RB: Clinical value of the London psychogeriatric rating scale. J Am Geriatr Soc 1978; 26:348-354

5. Frattali CM, Thompson CM, Holland AL, et al: The FACS of life ASHA facs-a functional outcome measure for adults. ASHA 1995;

37:40-46

6. Hopman-Rock M, Staats PG, Tak EC, et al: The effects of a psychomotor activation programme for use in groups of cognitively

impaired people in homes for the elderly. Int J Geriatr Psychiatry 1999; 14:633-642

7. Verstraten PF: The GIP: an observational ward behavior scale. Psychopharmacol Bull 1988; 24:717-719

8. Maring W, Deelman BG: The cognitive screening test: Long and short versions. Tijdschrift voor Gerontologie en Geriatrie. 1999; 30:205-

211

Supplemental Digital Content 2 - Music



Blinding of raters



rating

Ashida, 2000, USA (1)

Two weeks of no music therapy followed by reminiscence music therapy in 5 x daily sessions of an


20 residents with dementia from 2 residential care facilities,

Participants served as their own controls

No Level and characteristics of on-task active and passive participation as recorded on videotape

Behavioral observations demonstrated nonsignificant increase in active participation and decrease in passive participation in 3 of the 4

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3

average 43 mins, over 1 week

divided into 4 small groups and treated identically (17 females)

groups as treatment weeks progressed.

Cevasco and Grant, 2003, USA (2)(See SDC 1 for exercise component of this study)

Exercise-to-music activity consisting of combinations of vocal music vs instrumental music and with instruments vs without instruments during 26 weekly or twice weekly 50 min sessions over 6 months


12 assisted living residents with early to middle AD (11 females)

Order of movement activities randomized but method not stated. Participants served as their own controls

No Responsiveness and participation in structured, designated movement or approximating the movement or not participating recorded at 30 sec intervals by trained data collectors

Exercise to instrumental music resulted in significantly higher participation than exercise with instruments to vocal music (t = 2.6, p < .05).

6

Clair, 2002, USA (3)

Music therapy - singing or dancing in weekly sessions of 40 min over 6 weeks


8 couples consisting of residents with advanced dementia in a SCU and their caregivers (4 female residents)


No Engagement: interaction between caregiver and care receiver defined as touch, conversation or looking as well as singing, vocalising, moving or dancing to music as recorded by a trained observer.

Highly significant increase in mean, posttest engagement scores when compared with pretest engagement scores (t = 2.88, p = .024).

5

Gaebler & Hemsley, 1991, UK (4)

Musical, auditory stimulation on one occasion only

Pretest-posttest design without parallel control group.No f/u

6 female, inpatients with severe dementia in a long-stay geriatric ward


No Behavioral engagement as measured by number of animated facial expressions and facial gestures as well as occasions where observable stimuli were followed, interaction attempts were initiated and absorption or involvement in an activity

No significant changes in 5 residents. One participant showed a significant mean change score between pre- and post-test on looking, facial gestures, interaction and interest (p < 0.1).

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4

was evident as recorded by a trained observer.

Groene, 2001, USA (5)

Music therapy consisting of 4 singalong group sessions of combinations of each of the 4 conditions: live (L) and recorded (R) presentation modes with simple (S) and complex (C) accompaniment styles. Total sessions 16. Duration and frequency not reported


8 residents with dementia in a SCU (7 females)

Order of conditions (L/S, L/C, R/S, R/C) randomized by a latin square design. No further details of allocation provided.

Not stated

Participation and responding as measured by number of: affirmative verbalisations made, leaving the group, facing therapist with eye contact, readiness to sing, nods of affirmation before and after sessions + reading lyrics, singing or mouthing songs and applauding

Participation, as evidenced by affirmative verbalisations (t(238) = 2.66, p = < .01) and applause after (t(238) = 2.03, p = < .043) were significantly higher for live sessions, overall, than for recorded; leaving the group was significantly higher for R/S condition (p = ≤ .01); joining in with reading lyrics was significantly higher for L/C condition (p = .03); facing therapist with eye contact at end of songs was significantly higher for L/C and R/C conditions (p = .00); applause was significantly higher for L/C condition (p ≤ .02)

10

Holmes et al, 2006, UK (6)

Live interactive music therapy vs pre-recorded music sessions vs silence during 1 x 1.5 hr session consisting of 30 min period for each condition


32 NH residents with moderate to severe dementia (28 females)

Order of silence and musical periods randomized. Method not stated

Blinded independent, observer-raters

Reduced apathy through positive engagement as measured by DCM, Behavior Category Codes (7, 8) according to video recordings rated at 3 min intervals by a trained, independent rater

Positive engagement during live music sessions was significantly greater than during pre-recorded music (p < .01) and silent (p < .00) sessions; positive engagement during pre-recorded music was not significantly greater than during silent periods.

13

Lord & Garner, 1993, USA (9)

Music group activity vs puzzle exercises vs usual recreational activities of

Pseudo- RCT.No f/u

60 residents with AD in a nursing care facility (42 females)

Participants nonsystematically separated into 3 equal groups and

Blinded analyses but raters not blinded

Change in social coaction ratings on a four-point scale developed by the authors. Active participation measured in

Significant difference in mean gain participation scores for pre and post observations in music group (M = 1.60, t19 = 8.72,

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5

drawing, painting and TV during 6 x 30 min sessions per week over 6 months

served as their own controls

the music group by singing, humming, playing an instrument or moving to the music as observed on a total 72 occasions per resident. Similar definitions of participation developed for puzzle and usual recreational groups.

p < .01) but not puzzle or usual recreational activities groups. Anecdotal evidence indicates residents in music group smiled, laughed, sang, danced, whistled and eagerly anticipated the sessions while those in other groups did not.

Mathews et al, 2001, USA (10)

Exercise activities vs exercise activities with rhythmic music, 22 mins x 5 days per week over 25 weeks


18 residents in a residential, dementia SCU (17 females)


No Engagement as defined by participation in the exercise activities using weekly observations taken twice during each 22 min session

Mean group engagement scores increased in the exercise activities with rhythmic music condition (M = 68-69%) when compared with exercise activities alone (M = 41-53%). Statistical significance not reported.

6

Pollack & Namazi, 1992, USA (11)

Individualised music activity vs other activity of choice in 6 x 20 min sessions, 3 per week over 2 weeks

Pretest-posttest design without parallel control group.No f/u

8 residents with probable AD in a specialist AD residential facility (5 females)


No Change in social behaviors and participation, as recorded before and after music sessions, by frequency of interaction, gesturing, smiling, touching, humming, singing and whistling as well as change in passive, nonsocial behaviors.

Increase in social behavior (24%) and a decrease in nonsocial and passive behavior (14%) for the group at close of treatment period (x² = 14.2, df = 1, p < .001)

4

Raglio et al, 2008, Italy (12)

Nonverbal music therapy using rhythmical and melodic instruments vs educational and entertainment

Psuedo- RCT.4 week f/u

59 residents with AD or VaD from 3 NHs). Experimental group n = 30; control group

Residents allocated alternately to control or experimental group

Yes Apathy change scores as measured by the NPI (13) as well as active participation as measured by empathetic behavior, smiles, singing and body movements synchronic

Significant improvement in apathy scores between pretest and follow up (F1,57 = 8.10, p < .05) in treatment group but not control group. Active participation also increased in the treatment

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6

activities in 10 x 30 min session over 16 weeks

n = 29 (25 females each group).

with the music group over time: empathetic behavior (F3,87 = 10.37, p < .0001; Cohen d = .61), smiles (F3,87 = 8.14, p < .0001; Cohen d = .53), singing (F3,87 = 6.98, p < .0003; Cohen d = .62) and synchronic body movements (F3,87 = 12.41, p < .0001; Cohen d = .62). Participation data for control group and group x time interaction effect not reported.

Sherratt et al, 2004, UK (14)

Live music (guitar playing and singing by semi-professional musician) vs taped commercial music vs taped recording of music played by the musician vs no music during 1hr sessions for each condition over 3 months. 4 conditions counter-balanced.


24 participants with moderate to severe dementia as well as signs of social withdrawal and minimal engagement (16 continuing care ward residents, 7 day hospital attendees and 1 observed across both settings (10 females)

Participants served as their own controls.

No Increased engagement defined as meaningful activity, engagement with music source, interaction with music source and specific responses to music (e.g. clapping, singing) as measured by DCM (7, 8) using continuous time sampling and direct observations by trained observers

Significant reduction in percentage of time spent in no meaningful activity for live music condition when compared with 3 other conditions (X2 (3) = 26.65, p = .01). Significant increase in percentage of time spent in engagement with music source (X2 (2) = 13.30, p = .01), interaction with music source (X2 (2) = 14.02, p = .01) and responses to music (X2 (2) = 12.90, p = .01) as well as significant reduction in percentage of time spent in no observable response to music (X2 (2) = 14.21, p = .01) for live music condition when compared with other music conditions. Significant reduction in percentage of time spent in passive behaviors for live

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7

music condition when compared with no music condition (X2 (3) = 7.95, p = .05).

Notes: f/u: follow up; AD: Alzheimer’s disease; SCU: special care unit; NH: nursing home; DCM: Dementia Care Mapping; RCT: randomized controlled trial; VaD: vascular dementia; NPI: Neuropsychiatric Inventory;

8

References

1. Ashida S: The effect of reminiscence music therapy sessions on changes in depressive symptoms in elderly persons with dementia. J Music

Ther 2000; 37:170-182

2. Cevasco AM, Grant RE: Comparison of different methods for eliciting exercise-to-music for clients with Alzheimer's disease. J Music Ther

2003; 40:41-56

3. Clair AA: The effects of music therapy on engagement in family caregiver and care receiver couples with dementia. American Journal of

Alzheimer's Disease and other Dementias. 2002; 17:286-290

4. Gaebler HC, Hemsley DR: The assessment and short-term manipulation of affect in the severely demented. Behavioural Psychotherapy

1991; 19:145-156

5. Groene R: The effect of presentation and accompaniment styles on attentional and responsive behaviors of participants with dementia

diagnoses. J Music Ther 2001; 38:36-50

6. Holmes C, Knights A, Dean C, et al: Keep music live: music and the alleviation of apathy in dementia subjects. Int Psychogeriatr 2006;

18:623-630

7. Sloane PD, Brooker D, Cohen L, et al: Dementia care mapping as a research tool. Int J Geriatr Psychiatry 2007; 22:580-589

8. Brooker D: Dementia care mapping: a review of the research literature. Gerontologist 2005; 45 11-18

9. Lord TR, Garner JE: Effects of music on Alzheimer patients. Perceptual and Motor Skills. 1993; 76:451-455

10. Mathews RM, Clair AA, Kosloski K: Keeping the beat: use of rhythmic music during exercise activities for the elderly with dementia.

American Journal of Alzheimer's Disease & Other Dementias 2001; 16:377-380

11. Pollack NJ, Namazi KH: The effect of music participation on the social behavior of Alzheimer's Disease Patients. J Music Ther 1992; 29:54-

67

12. Raglio AMT, Bellelli GMD, Traficante DPP, et al: Efficacy of Music Therapy in the Treatment of Behavioral and Psychiatric Symptoms of

Dementia. Alzheimer Dis Assoc Disord 2008; 22:158-162

13. Cummings JL, Mega M, Gray K, et al: The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia.

Neurology 1994; 44:2308-2314

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14. Sherratt K, Thornton A, Hatton C: Emotional and behavioural responses to music in people with dementia: An observational study. Aging

and Mental Health. 2004; 8:233-241

Supplemental Digital Content 3 - Multi-sensory



Blinding of raters



rating

Baker et al, 2003, UK, Netherlands & Sweden (1)

MSS vs control activity during 30 min sessions twice weekly over 4 weeks

RCT.1 month f/u

136 ITT and 127 IA older adults with dementia (94 community dwelling and 42 psychogeriatric inpatients); intervention group n = 65, control group n = 71.

Computer randomization with epidemiology software

No Apathy subscale of the BRS section of the Clifton Assessment Procedures for the Elderly (2, 3), apathetic/withdrawn subscale of the BMD (4, 5), non-social behavior subscale of the GIP (6) as well as spontaneity, initiative and inactivity as rated with the ‘Interact’ form developed by the authors (1)

No significant differences between MSS and control activity groups from before to after sessions.Significant main effects of time. Both groups related better to others [F(1,108) = 28.97, P < 0.0001] and were less bored /inactive [F(1,108) = 43.38, P < 0.0001] after sessions when compared with before. The severely cognitively impaired in the MSS group were significantly less apathetic on the BRS apathy subscale after sessions when compared with before [F(1,83) = 7.20, P < 0.01]. Improvement had deteriorated at follow-up.

12

Buettner 1999, USA (7)

“Simple Pleasures” i.e., readily accessible, age- and stage-appropriate sensorimotor recreational items

Interrupted, cross-over time series without parallel control group.No f/u, but 6 months post

55 NH residents with dementia in 2 dementia units (44 females)


No Time spent by residents in purposeful activities with sensorimotor recreational items as measured by the “Scanning the Environment Tool” and the “Time engaged with Item Scale” developed by the research

Decrease in mean number of instances of residents “not doing anything” during intervention period (site 1 M = 8.26, site 2 M = 10.85) when compared with control period (site 1 M = 17.52, site 2 M = 15.36). Observations indicate

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10

vs usual care over 12 months

intervention data available for group1 due to crossover design

team that residents were more involved with recreation items and other residents during intervention period. Statistical significance not reported.

Minner et al, 2004, USA (8)

MSS sessions to the total of 324 over 1 year

Interruptedtime series without parallel control group.No f/u

19 NH residents with dementia and difficult behaviors


No Positive vocalisation, smile, positive gestures, positive noise expression and positive interactions with people or objects as recorded using an observational checklist developed by first author.

Increase in mean number of positive behaviors per resident during (M = 5.3) and after sessions (M = 5.1) when compared with before (M = 3.7). Statistical significance not reported.

2

Moffat et al, 1993, UK (9)

MSS sessions of 30 mins duration 3 days per week, over 4 weeks

Interrupted, cross-over time series without parallel control group.No f/u

6 male patients with dementia from a continuing care ward and 6 female patients with dementia from a day hospital


Raters not blinded

Willingness to participate, interaction with others, interest and energy level during sessions as measured by a rating scale (10) as well as before and after sessions using an observation system (11). Behavior was also rated by the apathetic/withdrawn subscale of the BMD (4, 5).

Significant increase in frequency of observed interest during the 10 min pre-session period (tau = .43, p < 0.02) and 10 min post-session period (tau = .603, p < 0.003) over 4 weeks of study but no significant difference in mean interest was found between pre-and post-session scores. No significant difference between baseline and post MSS session scores on the apathetic/withdrawn subscale of the BMD.

9

Staal et al, 2007, USA (12)

MSBT for 6 sessions of up to 30min each + standard psychiatric care (i.e., pharmacological

Psuedo- RCT.No f/u

24 inpatients with moderate to severe dementia and

Not stated Apathy raters not blinded

Apathy as measured by the avolition-apathy, social-emotional withdrawal and affective blunting subscales of the SANS-AD (13)

MSBT group showed significantly greater improvement in apathy than control group when controlling for physical health and age (F(1, 20) = 4.47, p = .04). No main effect was

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11

therapy, occupational therapy and structured hospital environment) vs standard psychiatric care + structured activity sessions (no time frame reported)

behavioral disturbances in an acute, geriatric, psychiatric unit (16 females); intervention group n = 12, control group n = 12.

found for time but time x group interaction effect was significant (F(6, 120) = 3.15, p = .01).

Van Weert et al, 2005, Netherlands (14)

Individual MSS integrated in 24hr care vs usual care over 18 months

Clustered psuedo- RCT.No f/u

128 residents with dementia from 12 psychogeriatric wards of 6 NHs (61 completers included in both pre- and posttest)

Randomization at ward level. 4 wards randomized by ‘drawing lots’ and 2 were assigned. 61 participants served as their own controls

Independent observers rated video recordings however, caregiver observations unblinded

Apathetic behaviors i.e., attentiveness and responsiveness in relation to the environment, others and initiative as measured by the apathy subscale of the GIP (6)

Significant treatment effect for change score on apathetic behaviors in intervention group but not control group (p < .05)

9

Notes: MSS: multi-sensory stimulation; RCT: randomized controlled trial; f/u: follow up; ITT: intention to treat; IA: in analysis; BRS: Behavioral Rating Scale; BMD: Behaviour and Mood Disturbance Scale; GIP/BIP: Gedragsobservatieschaal voor de Intramurale Psychogeriatrie [Dutch Behavior Rating Scale for Psychogeriatric Inpatients]; NH: nursing home; MSBT: Multi sensory behavior therapy; SANS-AD: Scale for the Assessment of Negative Symptoms in Alzheimer’s Disease;

12

References

1. Baker R, Holloway J, Holtkamp CC, et al: Effects of multi-sensory stimulation for people with dementia. J Adv Nurs 2003; 43:465-477

2. Chung JC, Lai CK, Chung PM, et al: Snoezelen for dementia. Cochrane Database of Systematic Reviews 2002; CD003152

3. Gilleard CJ, Pattie AH, Dearman G: Behavioural disabilities in psychogeriatric patients and residents of old people's homes. J Epidemiol

Community Health 1980; 34:106-110

4. Greene JG, Smith R, Gardiner M, et al: Measuring behavioural disturbance of elderly demented patients in the community and its effects on

relatives: a factor analytic study. Age Ageing 1982; 11:121-126

5. Neville CC, Byrne GJ: Behaviour rating scales for older people with dementia: Which is the best for use by nurses? Collegian: Journal of the

Royal College of Nursing, Australia 2001; 20:166-172


7. Buettner LL: Simple Pleasures: A multilevel sensorimotor intervention for nursing home residents with dementia. American Journal of

Alzheimer's Disease. 1999; 14:41-52

8. Minner D, Hoffstetter P, Casey L, et al: Snoezelen activity: the Good Shepherd Nursing Home experience. J Nurs Care Qual 2004; 19:343-

348

9. Moffat N, Barker P, Pinkney L, et al: Snoezelen: An experience for people with dementia, Dorset, Rompa, 1993

10. Bender MP, Norris A, Bauckham P: Groupwork with the Elderly, Bicester, Oxon, Winslow Press, 1987

11. Gaebler HC, Hemsley DR: The assessment and short-term manipulation of affect in the severely demented. Behavioural Psychotherapy

1991; 19:145-156

12. Staal JA, Sacks A, Matheis R, et al: The effects of Snoezelen (multi-sensory behavior therapy) and psychiatric care on agitation, apathy,

and activities of daily living in dementia patients on a short term geriatric psychiatric inpatient unit. Int J Psychiatry Med 2007; 37:357-370

13. Reichman WE, Coyne AC, Amirneni S, et al: Negative symptoms in Alzheimer's disease. Am J Psychiatry. 1996; 153:424-426

14. van Weert JCM, van Dulmen AM, Spreeuwenberg PMM, et al: Behavioral and Mood Effects of Snoezelen Integrated into 24-Hour Dementia

Care. J Am Geriatr Soc. 2005; 53:24-33

Supplemental Digital Content 4 - Animals

13



Blinding of raters



rating

Batson et al 1998, USA (1)

The presence of a therapy dog with investigator vs investigator only during 1 of each individual, 10 min session on 2 different days

Pretest-posttest case series without parallel control group.No f/u

25 ITT and 22 IA residents with dementia in a SCU of a long-term care facility (12 females)

Random number table used to randomize order of conditions. No further details of allocation provided. Participants served as their own controls.

No Social interaction behaviors defined as frequency and duration of verbalisations, smiles, looks, leans toward and tactile contact as well as duration of physical warmth and praise as recorded by a data coding protocol developed by the authors and derived from previous research (1, 2)

Significant increase in the following behaviors in the presence of the therapy dog. Frequency scores for smiles (t = 2.33, p < .05), tactile contact (t = 4.35, p < .01), looks (t = 2.78, p < .05), physical warmth (t = 4.35, p < .01) and praise (t = 2.79, p < .01). Duration scores for leans (t = 2.08, p < .05), smiles (t = 3.30, p < .01), tactile contact (t = 2.83, p < .01) and looks (t = 4.42, p < .01)

10

Churchill et al, 1999, USA (3)

The presence of 2 handlers with a therapy dog vs the presence of 2 handlers only; 1 session each condition


28 residents with dementia in SCUs of 3 extended care facilities (21 females)

Order of conditions randomized. Method not stated.

No Socialisation behaviors defined as frequency and duration of verbalisations, smiles, looks, leans, and tactile contact as recorded by a data coding protocol developed by the authors and derived from previous research (2)

Significant increase in socialisation behaviors in the presence of the therapy dog. Mean duration in secs and frequency of socialisation behaviors was estimated at approximately doubled during the therapy dog condition. Statistical significance not reported.

6

Greer et al, 2001, USA (4)

The presence of toy cats vs live cats vs no stimuli during 3 x 10-minute sessions (no time frame reported)

Interrupted, cross-over time series without parallel control group.No f/u

6 female NH residents with moderate dementia

Order of condition randomized. Method not stated. Participants served as their own controls.

No. Video recordings scored by an examiner not present

Mean verbal initiations defined as utterances produced without a verbal model and total number of legitimate words produced within sessions

Greatest influence on overall performance observed for live cat condition (estimated mean difference between pre and post 0.8 initiations/min) when compared with toy cat condition (no difference). Performance effect was

4

14

at the session

greater in the group exposed to live cats before toy cats possibly due to participants in both groups progressively losing interest in the study. Statistical significance not reported.

Kongable et al,1989, USA (5)

Pet therapy: 1. Temporary (3hrs x 1 day per week) vs permanent residence of a dog2. Individual vs group settings on 3 separate occasions over 2 weeks


12 residents with AD in a SCU (2 females)

Observation periods were randomized Method not stated. Participants served as their own controls.

No Social behaviors i.e., smiles, laughs, looks, leans toward stimulus, touch stimulus, verbalisation, uses names and other means of communication as collected with an observational checklist developed by the first author

Significant increase in smiles (p = .001), laughs (p = .011), leans (p = .020), touches (p = .000), verbalisations (p = .024) and total social behaviors (p = .000) over time and in presence of dog when compared with absence of dog (p < .001); no significant differences between permanent and temporary residence of dog or between individual and group settings

5

Libin and Cohen-Mansfield, 2004, USA (6)

Robotic cat therapy vs plush toy cat therapy; 1 interactive session of 10mins each condition, on separate days vs no therapy


9 NH residents with moderate to severe dementia (all females)

Order of sessions randomized. Method not stated. Participants served as their own controls

No Engagement: quality, duration, attention, attitude and intensity of manipulation with stimuli as well as interest as rated by trained observers

Significant increase in interest for the robocat condition but not the plush cat t(8) = 2.7, p = .03). No significant differences were found for either condition in the engagement parameters.

8

Motomura et al, 2004, Japan (7)

Animal-assisted therapy with 2 dogs for 1 hour over 4 consecutive days


8 female, NH residents with mild dementia


No Activity and apathy state as measured by the apathy subscale of the Irritability/Apathy Scale (8)

Significant decrease in apathy scores after therapy (M = 14.0, SD = 3.5) when compared to before therapy (M = 19.4, SD = 3.7, p ≤ .05)

8

15

Richeson, 2003, USA (9)

Animal-assisted dog therapy for 1 hr daily vs usual care 5 days per week over 3 weeks

Interrupted time series without parallel control group.No f/u on social interaction

15 residents with dementia from SCUs within 2 NHs (14 females)


No Social interaction as rated by a trained observer using the 9 item Animal-Assisted Therapy flow sheet (10). Behaviors recorded include looking at, speaking to, touching, engaging in an activity with the dog or the handler.

Significant increase between pretest and posttest scores on social interaction (t(15) = -3.26, p = .009)

8

Notes: f/u: follow up; ITT: intention to treat; IA: in analysis; SCU: special care unit; NH: nursing home; AD: Alzheimer’s disease;

16

References

1. Batson K, McCabe B, Baun MM, et al: The effect of a therapy dog on socialization and physiological indicators of stress in persons

diagnosed with Alzheimer's Disease, in Companion Animals in Health. Edited by Wilson CC,Turner DC. Sage, CA, Thousand Oaks, 1998, pp 203-

215

2. Daubenmire J, White J, Heinzerling K, et al: Synchronics: a notation for the quantitative and qualitative description of presenting behaviors.,

Colombus, Ohio, Ohio State University Research Foundation, 1977

3. Churchill M, Safaoui J, McCabe BW, et al: Using a therapy dog to alleviate the agitation and desocialization of people with Alzheimer's

disease. J Psychosoc Nurs Ment Health Serv 1999; 37:16-22

4. Greer KL, Pustay KA, Zaun TC, et al: A comparison of the effects of toy versus live animals on the communication of patients with dementia

of the Alzheimer's type. Clin Gerontol 2001; 24:157-182

5. Kongable LG, Buckwalter KC, Stolley JM: The effects of pet therapy on the social behavior of institutionalized Alzheimer's clients. Arch

Psychiatr Nurs 1989; 3:191-198

6. Libin A, Cohen-Mansfield J: Therapeutic robocat for nursing home residents with dementia: Preliminary inquiry. American Journal of

Alzheimer's Disease and other Dementias. 2004; 19:111-116

7. Motomura N, Yagi T, Ohyama H: Animal assisted therapy for people with dementia. Psychogeriatrics 2004; 4:40-42

8. Burns A, Folstein S, Brandt J, et al: Clinical assessment of irritability, aggression, and apathy in Huntington and Alzheimer disease. J Nerv

Ment Dis 1990; 178:20-26

9. Richeson NE: Effects of animal-assisted therapy on agitated behaviors and social interactions of older adults with dementia. American

Journal of Alzheimer's Disease & Other Dementias 2003; 18:353-358

10. Richeson NE, McCullough WT: An evidence-based animal-assisted therapy protocol and flow sheet for the geriatric recreation therapy

practice. American Journal of Recreation Therapy. 2002; 1:25-31

Supplemental Digital Content 5 - Special Care Programming

17



Blinding of raters



rating

Bellelli et al, 1998, Italy (1)

Specifically designed SCU dementia program over 6 months


55 patients with moderate to severe dementia and severe behavioral disturbances in 8 SCUs (43 females)

Residents admitted consecutively to the SCUs from waiting list. Participants served as their own controls

No Apathy as measured by the NPI (2)

Significant reduction in apathy between admission (M = 5.6, SD = 5.1) and 3 month follow-up (M = 3.3, SD = 3.8 p = .005) which was maintained at 6 month follow-up (M = 3.3, SD = 3.7, p = .014).

11

Chafetz, 1991, USA (3)

Dementia SCU with specialised elements vs dementia SCU without specialised elements over 13-15 months

Non-randomized experimental trial.No f/u

NH residents in specialised SCU sample sizes: 23, 18, 12 and non- specialised SCU sample sizes: 11, 10, 8 at 3 time points (all female except 1 male at time points 1 & 2).

No random assignment

No Initiation as measured by the Dementia Rating Scale (4, 5) and recorded as ranked percentage of maximum, possible points.

No significant difference between initiation scores over time in SCU with specialised elements and SCU without specialised elements (p > 0.05)

7

Colombo et al 2007, Italy (6)

Dementia SCU providing “Gentlecare”, a multifaceted, non-pharmacological, prosthetic approach (7) over 8 weeks


214 NH residents with dementia in a SCU (140 females)


Not stated Apathy scores at admission and discharge as measured by the NPI (2)

Highly significant reduction in apathy on discharge (M = 2.9, SD = 3.7) when compared with admission scores (M = 5.2, SD = 4.6, p < 0.001)

8

Lawton et al, 1998,

Stimulation-retreat model of

Clustered RCT.

182 ITT and 97 IA NH

SCUs randomized

No External behavioral engagement: social

Significant increase for activites and time use in

10

18

USA (8) care (combined staff training, interdisciplinary care planning, activity programming and family support) vs usual care over 12 months

No f/u residents with moderate to severe dementia in 2 SCUs (14 females); intervention group n = 88, control group n = 94

using a coin toss

behaviors, activities, time use and gazing with interest as measured with the withdrawal factor of the MOSES (9) as well as a behavior rating scale and an activity participation scale developed by the authors. Observations were rated using the Observed Emotion Rating Scale (10) (previously known as the Philadelphia Geriatric Center Affect Rating Scale (11))

experimental group (multivariate F = 2.51, df = 14,272, p < .01) but not control group. No significant changes for passive behaviors or gazing with interest; no significant effect for group x time interaction on interest.

Volicier et al, 2006, USA (12)

Continuous activity programming in the presence of a staff member, engaging residents in meaningful structured or unstructured activities over 3 months


90 residents from 2 dementia SCU (veterans, predominately male)

No random assignment

No however, observations completed by staff not involved in activity programming

Social isolation and time spent engaged in activities as recorded for a quality improvement activity and an anonymous staff survey.

Increase in percentage of waking time spent engaged in activities in SCUb and significant decrease in social isolation in SCUa post intervention when compared with pre (p < .01) ;qualitative data suggests increased willingness to participate in activities

3

Notes: SCU: special care unit; f/u: follow up; NPI: Neuropsychiatric Inventory; NH: nursing home; RCT: randomized controlled trial; ITT: intention to treat; IA: in analysis; MOSES: Multidimensional Observation Scale for Elderly Subjects

19

References

1. Bellelli G, Frisoni GB, Bianchetti A, et al: Special care units for demented patients: a multicenter study. Gerontologist 1998; 38:456-462


Neurology 1994; 44:2308-2314

3. Chafetz PK: Behavioral and cognitive outcomes of SCU care. Clinical Gerontologist. 1991; 11:19-38

4. Marson DC, Dymek MP, Duke LW, et al: Subscale validity of the Mattis Dementia Rating Scale. Archives of Clinical Neuropsychology. 1997;

12:269-275

5. Alexopoulos GS, Mattis S: Diagnosing cognitive dysfunction in the elderly: Primary screening tests. Geriatrics. 1991; 46:33-44

6. Colombo M, Vitali S, Cairati M, et al: Behavioral and psychotic symptoms of dementia improvements in a special care unit: A factor analysis.

Arch Gerontol Geriatr 2007; 44:113-120

7. Jones M: Gentlecare: Changing the Experience of Alzheimer's in a Positive Way, Vancouver, BC, Hartley & Marks 1999

8. Lawton MP, Van Haitsma K, Klapper J, et al: A stimulation-retreat special care unit for elders with dementing illness. Int Psychogeriatr.

1998; 10:379-395

9. Helmes E, Csapo KG, Short JA: Standardization and validation of the Multidimensional Observation Scale for Elderly Subjects (MOSES). J

Gerontol 1987; 42:395-405

10. Lawton MP, Van Haitsma K, Klapper J: Observed Emotion Rating Scale [H:\jmarainen\Web site\OERS\OBSERVED EMOTION RATING

SCALE.doc]. , 1999

11. Lawton MP, Van Haitsma K, Klapper J: Observed affect in nursing home residents with Alzheimer's disease. J Gerontol B Psychol Sci Soc

Sci. 1996; 51:3-14

12. Volicer L, Simard J, Pupa JH, et al: Effects of continuous activity programming on behavioral symptoms of dementia. Journal of the

American Medical Directors Association 2006; 7:426-431

Supplemental Digital Content 6 - Therapeutic Activities

20



Blinding of raters



rating

Bailey, 2000, USA (1)

Question-asking Reading (2) activity with a reminiscence component + individually prescribed behavioral program + prompt signs vs usual NH activities during 30 min sessions twice weekly over 6 weeks


44 ITT and 40 IA cognitively impaired residents of 4 NHs (35 females) ); intervention group n = 21, control group n = 19

NH units randomized. Method not stated

No Engagement defined as participation, turning toward, responding, eye contact and/or eyes following as recorded by the Activity Behavior Checklist and General Behavior Checklist; interest as measured by the Affect Rating Scale. All developed by author.

Significant increase in engagement during Question-asking Reading activity (F = 31.64, p = .05) but no significant difference between groups following activity. No significant change for interest on the Affect Rating Scale.

10

Beuttner et al, 2006, USA (3)

Individually prescribed therapeutic recreation 5 x weekly vs usual care + daily x 20 min social visits from research team over 2 weeks

Crossover psuedo- RCT.No f/u

112 ITT and 107 IA residents of 5 long-term care residences with dementia (82 females)

Method of randomisation not stated. Participants also served as their own controls

No Reduced apathy defined as engagement or an alerting effect on passive behaviors as measured by time involved, level of engagement, encouragement needed and participation levels.

Passive residents alerted 79-91% of the time, depending on the intervention category Those activities in the physical intervention category showed the greatest percentage engagement. Statistical significance not reported.

6

Chapman et al, 2004, USA (4)

Cognitive-communication stimulation program with home assignments plus donepezil vs donepezil only over 8 weeks

RCT.8 & 12 month f/u

50 ITT and 41 IA community-dwelling older adults with mild to moderate AD (29 females); intervention group n = 26, control group n = 28

Random assignment generated using SAS statistical software (SAS Institute, Cary, NC).

Apathy item raters blinded

Apathy change scores as measured by the NPI (5)

Apathy change scores for the cognitive-communication program with donepezil approached significance (M = -1.10, p = .08) suggesting reduced apathy over time. Lower apathy scores maintained at follow-up.

12

Fitzsimmons and Buettner, 2002, USA

Individually prescribed, at-home, therapeutic recreation

Crossover psuedo- RCT.

30 ITT and 29 IA community-dwelling older

Method of randomization not stated.

No Passivity defined as “initiative”, “interaction with surroundings”,

Significant improvement in passivity (p = .00) for intervention condition but

9

21

(6) during 1.5 hr sessions x 3-5 days per week, over 2 weeks vs usual homecare control condition followed by individually prescribed, therapeutic recreation

No f/u adults with dementia (19 females); intervention group n = 29, control group n = 30

Participants also served as their own controls

“involvement with others” and “busy during the day” as measured by Colling’s (7) NH version of the PDS (8).

not control.

Fitzsimmons and Buettner, 2003, USA (9)

Adaptive therapeutic recreation cooking program of 1 hr sessions x 5 days per week, over 2 weeks vs usual facility activities followed by adaptive therapeutic recreation cooking program

Crossover psuedo-RCT.No f/u

24 female residents of a locked SCU with dementia and disturbed behaviors; intervention group n = 12, control group n = 12

Method of randomization not stated. Participants also served as their own controls

No Passivity as measured by the PDS (8) as well as engagement, active or passive participation and encouragement needed as recorded by trained observers.

Highly significant decrease in post-test passivity compared with pre-test scores for intervention group (p < .00) but not control group

9

Gitlin et al 2008, USA (10)

Tailored Activity Program, an OT intervention of activities customised to capabilities during 6 x 90 min home visits and 2 x 15 min ‘phone contacts over 4 months vs wait-list control/delayed intervention group

Crossover RCT.No f/u

60 ITT and 56 IA patients with dementia living in the community and their caregivers (26 female patients); intervention group n = 30, control group n = 30

Randomized using random permuted blocks. Participants also served as their own controls

Yes Activity engagement measured with a five-item, investigator-developed index of caregiver report.

Significant increase in activity engagement (F(1,43) = 5.1, p = .03, Cohen’s d = 0.61) and ability to keep busy (F(1,43) = 6.2, p = .02 Cohen’s d = 0.71) in treatment group but not control group

12

Kolanowski, 2005, USA (11)

Activities matched to skill level only vs activities matched to style of interest only vs activities matched to both skill level and


33 ITT and 30 IA NH residents with dementia (23 females)

Order of condition randomized with permuted blocked randomization

Engagement raters blinded

Passivity as measured by the 12 passive behavior items of the PDS (12) as well as engagement as measured by time on

Significant improvement in passivity and engagement (p ≤ .001) when activities were matched to style of interest or matched to both skill level and style of

12

22

style of interest implemented for up to 20 mins daily over 12 consecutive days

scheme. Participants served as their own controls

task and intensity of participation.

interest.

Kovach and Henschel, 1996, USA (13)

5 types of therapeutic activities vs those therapeutic activities which generate a cognitive tie as demonstrated by reminiscence (no duration reported)


23 residents with mid-stage dementia from 2 SCUs (19 females)


No Verbal engagement, physical engagement or paying attention as measured by active or passive participation in therapeutic activities as observed at 3 min intervals during 94 sessions

Significant difference in active participation for therapeutic activities when a cognitive tie could be made, as demonstrated by reminiscence (X2 = 7.43, p = .02)

6

Orsulic-Jeras et al, 2000, USA (14)

Montessori-based activities (individual and small group) vs regular activities (large and small group) programming in 15-30 min sessions twice weekly, over 9 months


16 residents in an advanced dementia unit (14 females)


No 4 levels of engagement: constructive (CE), passive (PE), non (NE) and self (SE) engagement observed in 10 min windows as measured by a scale developed by the authors (15)

Significant main effect for CE (F(1,15) = 102, p < .001) and PE (F(1,15) = 5.5, p < .03). Instances of NE and SE not often observed during either activity periods

8

Politis et al, 2004,USA (16)

Kit-based activity intervention vs one to one time and attention intervention for 30 mins, 3 x per week over 4 weeks

RCT.No f/u

36 residents of a specialist long term dementia care facility (18 females); intervention group n = 18, control group n = 18

Table of random numbers in blocks of 4.

Raters masked to treatment assignment

Apathy as measured by the NPI (5) and activity participation as measured by the CRAI developed by Copper Ridge Institute (16)

Significant within group improvements on NPI apathy in both kit-based intervention group (z = -1.92, p = .05) and one to one intervention group (z = -2.68, p = .01). No significant difference between groups in activity participation on the CRAI.

12

Rogers et al, 1999, USA (17)

Individualised, behavioral rehabilitation designed to identify

Interrupted time series without parallel

84 residents with probable or possible AD from 5 NHs (58


No Initiation, time spent engaged and active participation in dressing and other ADLs as

Significant increase and improvement in mean active participation, self-initiation and self-dress

9

23

and elicit retained ADL skills over 5 consecutive days vs usual care over 5 consecutive days vs habit training (behavioral rehabilitation continued to reinforce retained ADL skills) over 15 consecutive week days

control group.F/u after further 15 days “habit training” period

females) observed by researcher using a computer-assisted data collection system

during ADLs when skills elicitation condition compared with usual care (Wilcoxon Signed Rank test = 1698, p = < .001) and when habit training condition compared with usual care (Wilcoxon Signed Rank test = 1650, p = < .001)

Rosswurm, 1990, USA (18)

Attention-focusing Group Program (19) vs unplanned social groups; 3 small group sessions of 30 mins per week over 4 weeks

Psuedo- RCT.No f/u for social interaction or participation

30 residents with dementia from 3 NHs (18 females); intervention group n = 15, control group n = 15

Not stated No Social interaction and group participation as quantified by 2 observers

Significant difference between pretest and posttest scores on social interaction and group participation (t = 3.81, p < .00); qualitative data suggests improved motivation, group cohesiveness and morale in the treatment group but not the control group

9

Tappen and Williams, 2009, USA (20)

Therapeutic Conversation, a psychotherapeutic approach modified for individuals with AD, 30 min sessions 3 x weekly vs usual care over 16 weeks

Psuedo- RCT.No f/u

36 ITT and 30 IA NH residents with mild to severe AD (17 females); intervention group n = 15, control group n = 15

Not stated Yes Apathy subscale of the Alzheimer’s Disease and Related Disorders Mood Scale (21)

Apathy subscale scores significantly decreased in treatment group but not control group (F(2,27) = 4.21, p = .05).

9

Weber et al, 2009, Switzerland (22)

Psychotherapeutic day hospital treatment consisting of one each of music therapy, movement

Interrupted time series without parallel control group.

76 day hospital attendees with dementia and BPSD (37 females)


No Apathy as measured by the NPI (5)

Apathy scores significantly decreased across the 3, 6 and 12 month time points (β = -2.34, p = .02) when controlling for

7

24

therapy, psychodynamic therapy and sociotherapy groups weekly over each individuals’ day hospital admission (median period 8 months)

No f/u demographics, medication changes, and significant life events.

Dementia with depressionBuettner and Fitzsimmons, 2002 USA (23)

Daily, small group therapy sessions of 1 hour which included wheelchair bicycle rides over 2 weeks; followed by a twice weekly maintenance program over 10 weeks vs control/delayed intervention group

Psuedo- RCT.F/u after further 10 week “mainten-ance” program

70 long-term care residents with dementia and depressive symptoms indicated by a GDS (short form; 24) score of ≥4

Not stated No Activity participation as recorded by trained observers, as an indicator of social participation

Significant increase in activity participation between pretest (M = 4.90) and post-test at 2 weeks (M = 13.52, t = 7.68, p < .00) as well as between pretest and follow up (M = 9.95, t = 5.22, p < .00) in treatment group but not control group. No group x time interaction effect reported.

5

Notes: NH: nursing home; RCT: randomized controlled trial; f/u: follow up; ITT: intention to treat; IA: in analysis; AD: Alzheimer’s disease; NPI: Neuropsychiatric Inventory; PDS: Passivity in Dementia Scale; SCU: special care unit; OT: occupational therapy; CRAI: Copper Ridge Activities Index; ADL: activities of daily living; BPSD: behavioural and psychological symptoms of dementia; GDS: Geriatric Depression Scale

25

References

1. Bailey EM: The effects of a multi-component intervention for improving the quality of life of cognitively impaired nursing home residents,

Tuscaloosa, Alabama, 2000

2. Stevens AB, Camp CJ, King CA, et al: Effects of a staff implemented therapeutic group activity for adult day care clients. Aging & Mental

Health. 1998; 2:333-342

3. Buettner LL, Fitzsimmons S, Serdar Atav A: Predicting outcomes of therapeutic recreation interventions for older adults with dementia and

behavioral symptoms. Ther Recreation J 2006; 40:33-47

4. Chapman SB, Weiner MF, Rackley A, et al: Effects of cognitive-communication stimulation for Alzheimer's disease patients treated with

donepezil. J Speech Lang Hear Res 2004; 47:1149-1163


Neurology 1994; 44:2308-2314

6. Fitzsimmons S, Buettner LL: Therapeutic recreation interventions for need-driven dementia-compromised behaviors in community-dwelling

elders. American Journal of Alzheimer's Disease & Other Dementias 2002; 17:367-381

7. Colling KB: Passive behaviors in dementia. Clinical application of the need-driven dementia-compromised behavior model. J Gerontol Nurs

1999; 25:27-32

8. Antonakos CL, Colling KB: Using measures of agreement to develop a taxonomy of passivity in dementia. Res Nurs Health 2001; 24:336-

343

9. Fitzsimmons S, Buettner LL: A therapeutic cooking program for older adults with dementia: effects on agitation and apathy. American

Journal of Recreation Therapy 2003; 2:23-33

10. Gitlin LN, Winter L, Burke J, et al: Tailored activities to manage neuropsychiatric behaviors in persons with dementia and reduce caregiver

burden: A randomized pilot study. American Journal of Geriatric Psychiatry. 2008; 16:229-239

11. Kolanowski AM, Litaker M, Buettner L: Efficacy of theory-based activities for behavioral symptoms of dementia. Nurs Res 2005; 54:219-228

12. Colling KB: A taxonomy of passive behaviors in people with Alzheimer's disease. Journal of Nursing Scholarship 2000; 32:239-244

26

13. Kovach CR, Henschel H: Planning activities for patients with dementia: a descriptive study of therapeutic activities on special care units. J

Gerontol Nurs 1996; 22:33-38

14. Orsulic-Jeras S, Judge KS, Camp CJ: Montessori-based activities for long-term care residents with advanced dementia: effects on

engagement and affect. Gerontologist 2000; 40:107-111

15. Judge KS, Camp CJ, Orsulic-Jeras S: Use of Montessori-based activities for clients with dementia in adult day care: Effects on

engagement. American Journal of Alzheimer's Disease. 2000; 15:42-46

16. Politis AM, Vozzella S, Mayer LS, et al: A randomized, controlled, clinical trial of activity therapy for apathy in patients with dementia residing

in long-term care. Int J Geriatr Psychiatry 2004; 19:1087-1094

17. Rogers JC, Holm MB, Burgio LD, et al: Improving morning care routines of nursing home residents with dementia. J Am Geriatr Soc. 1999;

47:1049-1057

18. Rosswurm MA: Attention-focusing program for persons with dementia. Clin Gerontol 1990; 10:3-16

19. Rosswurm MA: Assessment of perceptual processing deficits in persons with Alzheimer's disease. West J Nurs Res 1989; 11:458-469

20. Tappen RM, Williams CL: Therapeutic conversation to improve mood in nursing home residents with Alzheimer's disease. Research in

gerontological nursing. 2009; 2:267-275

21. Tappen RM, Williams CL: Development and testing of the Alzheimer's Disease and Related Dementias Mood Scale. Nurs Res 2008;

57:426-435

22. Weber K, Meiler-Mititelu C, Herrmann FR, et al: Longitudinal assessment of psychotherapeutic day hospital treatment for neuropsychiatric

symptoms in dementia. Aging and Mental Health. 2009; 13:92-98

23. Buettner LL, Fitzsimmons S: AD-venture program: Therapeutic biking for the treatment of depression in long-term care residents with

dementia. American Journal of Alzheimer's Disease and other Dementias 2002; 17:121-127

24. Sheikh JI, Yesavage JA: Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontologist.

1986; 5:165-173

Supplemental Digital Content 7 - Miscellaneous Interventions

27

Study Interventions Study design.Follow up


Blinding of raters

Outcomes relevant to apathy Significance Quality

rating

Camberg et al, 1999, USA (1)

SimPres® (i.e., personalised audiotapes which aim to replicate the presence of caregiver) vs placebo audiotape of emotionally neutral newspaper articles vs usual care for 17 days over 4 weeks with a 10-day washout period between treatments.

Pseudo- RCT.No f/u

54 residents with dementia from 9 NHs (48 females)

Intervention applied in a restrictively randomized manner when staff chose either intervention or placebo tape to manage resident behaviors

NH staff and trained observers blinded to audiotape content

Withdrawn behavior defined as lack of interest in people, activities or things in participants’ environment combined with sad mood as measured by the interest and pleasure items of the Observed Emotion Rating Scale (2) (previously known as the Philadelphia Geriatric Center Affect Rating Scale) (3) and a withdrawn visual analogue scale with anchors of “apathy” and “engagement”. Data collection methods include daily staff observation logs (total observations = 1,981) direct observations and weekly staff behavioral rating surveys.

Staff observation logs indicated that SimPres® improved withdrawn behavior on significantly more occasions (69%) than usual care (55%; p < .00) and placebo (34%; p < .00); direct observations showed no significant differences between conditions; weekly staff surveys indicated that SimPres® increased level of interest significantly more than placebo (p = .01) and usual care (p = .00).

12

Caserta and Lund, 2002, USA (4)

VR using a 20 min generic videotape which reminisces about growing up in the 1920s-30s; group viewing vs solitary viewing over 4 weeks


12 NH residents with dementia (10 females)

Order of viewing sessions randomized. Method not stated

No Participation and interest: direct eye contact, verbal and nonverbal responses (e.g., facial expressions, nodding) to questions as well as requests to sing and make movements as rated by trained coders.

Significantly higher nonverbal responses (z = -2.22, p < .03) and a nonsignificant trend toward higher verbal responses occurred in the solitary viewing condition when compared to the group viewing condition. No significant change on interest or eye contact.

7

Droes et Combined support for Pretest- 112 ITT and 89 No No Degree of inactivity and non- Significant improvement in 9

28

al, 2004, Netherlands (5)

people with dementia and caregivers vs non-integrated support (regular psychogeratric day care) over 7 months

posttest design with control group.No f/u

IA day care attendees with dementia and their caregivers (39 female attendees); intervention group n = 73, control group n = 16

randomization. Participant groups attending different centres

social behavior inactivity (ANCOVA adjusted m = 5.0/6.3 (3.4), d = -0.37, p ≤0.05) and non-social behavior (ANCOVA adjusted m = 5.0/7.4 (4.0), d = -0.60, p ≤0.01) following integrated family support.

Finnema et al, 2005, Netherlands (6)

Integrated emotion-oriented care in combination with the Dutch Assoc. of NH Care Model-Care plan vs usual care in accordance with the Model-Care plan over 7 months

Clustered interrupted time series with control group.No f/u

194 ITT and 146 IA residents with dementia from 14 NH (118 females); intervention group n = 67, control group n = 79

Random assignment of best matched pairs of wards. Method not stated

Partial blinding of assessors

Apathetic behavior and non-social behavior as measured by the BIP (also known as GIP) (7) and inactivity as measured by the apathy subscale of the Assessment Scale for Elderly Patients (8)

No significant change in inactivity or apathetic and non-social behaviors for emotion-oriented care.

10

Hall and Hare, 1997, USA (9)

VR using a 21 min, generic videotape which combines reminiscence and music during a single session

Interrupted time series without control group.No f/u

36 residents with cognitive impairment from 3 NHs (28 females)


No Positive, interactive, social behaviors: sitting, walking, standing, talking with others as well as singing, smiling, positive gesturing and responding verbally as observed by trained raters and chart review. Observation data were gathered for a total of 63 mins: 21 mins pre-VR, 21 mins during VR and 21 mins post-VR.

Significant increase in mean difference scores for positive, interactive, social behaviors between pre-VR and during VR (t = -4.0, p < .00). Decreased positive behaviors following treatment condition demonstrated by a significant decrease in mean difference scores for positive, interactive, social behaviors between during VR and post-VR (t = 2.62, p < .01). No significance between pre-VR and post-VR.

6

29

Hanley et al, 1981, UK (10)

RO (11) classes for 30 min, 4 x weekly over 12 weeks vs usual care

Psuedo- RCT.No f/u

58 ITT and 57 IA patients with dementia from a psychogeriatric hospital and an old people’s home (53 females); intervention group n = 28, control group n = 29

Not stated No Withdrawal/apathy as measured by the Geriatric Rating Scale (12)

No significant difference in withdrawal/apathy change scores between RO and control group. No significant effect for location or group x location interaction.

8

Lai et al, 2004, Hong Kong, China (13)

Individual RT program weekly for 30 min over 6 weeks vs social contact comparison program vs no intervention

RCT.6 weeks f/u

101 ITT and 86 IA NH residents with dementia (69 females); intervention group n = 36, control group n = 30, comparison group n = 35

Fixed allocation randomization (14)

Assessors blinded to participant assignment

Engagement eg: interaction, self-initiated activities and involvement as measured with the Social Engagement Scale (15, 16)

Significant difference over time within RT group (p = .014) but not the comparison or control groups. No significant difference between subject effects or within subject effects for interaction between time and group or between time and regular program.

13

Schrijnemaekers et al, 2002, Netherlands (17)

Emotion-oriented care (18) (based on validation (19), RT and sensory stimulation approaches) vs usual care over 12 months


151 residents with cognitive impairment and behavioral problems attending structured day-care units in 16 NHs (136 females); intervention group n = 77, control group n = 74

NHs randomized. Method not stated

No Apathetic and non-social behavior subscales of the short version of the GIP (7) at baseline, 3 months, 6 months and 12 months

No significant difference between intervention and control groups for apathetic or non-social behaviors.

11

30

Tabourne 1995, USA (20)

Structured RT (life review) during 2 sessions weekly over 12 weeks vs similar recreation activities without cueing for reminiscence

Pseuo- RCT.Some qualitative data reported 1 month after intervention.

40 ITT and 32 IA NH residents with dementia or cognitive impairment (35 females); intervention group n = 16, control group n = 16

Not stated No Level of participation, social interaction, initiation and ability to remain engaged as reported and rated by unobtrusive observer

Significant increase in social interaction (t = 11.58, p < .00) and engagement (t = 13.83, p < .00) for RT group but not control group.

8

Tadaka and Kanagawa, 2007, Japan (21)

RT during 60-90 min weekly sessions vs routine day care service over 8 consecutive weeks

RCT.6 months f/u

60 ITT and 50 IA elderly attendees of community day care with dementia (20 AD, 30 VaD, 42 females); intervention group n = 30, control group n = 30

Computer generated randomization within subsets of dementia type

No Degree of withdrawal as measured by the withdrawal subscale of the MOSES (22)

Significant improvement on withdrawal for RT in AD group immediately following intervention but not at follow-up (p < .05); significant improvement immediately following intervention and at follow up on withdrawal for RT in VaD group (p < 0.01)

11

Notes: SimPres®: Simulated Presence Therapy; RCT: randomized controlled trial; f/u: follow up; NH: nursing home; VR: Video respite™; ITT: intention to treat; IA: in analysis; GIP/BIP: Gedragsobservatieschaal voor de Intramurale Psychogeriatrie [Dutch Behavior Rating Scale for Psychogeriatric Inpatients]; RO: reality orientation; RT: reminiscence therapy; AD: Alzheimer’s disease; VaD: vascular dementia; MOSES: Multidimensional Observation Scale for Elderly Subjects

31

References

1. Camberg L, Woods P, Ooi WL, et al: Evaluation of Simulated Presence: a personalized approach to enhance well-being in persons with

Alzheimer's disease. J Am Geriatr Soc 1999; 47:446-452

2. Lawton MP, Van Haitsma K, Klapper J: Observed Emotion Rating Scale [H:\jmarainen\Web site\OERS\OBSERVED EMOTION RATING

SCALE.doc]. , 1999

3. Lawton MP, Van Haitsma K, Klapper J: Observed affect in nursing home residents with Alzheimer's disease. J Gerontol B Psychol Sci Soc

Sci. 1996; 51:3-14

4. Caserta MS, Lund DA: Video respite in an Alzheimer's care center: group versus solitary viewing. Activities, Adaptation and Aging. 2002;

27:13-28

5. Droes RM, Meiland F, Schmitz M, et al: Effect of combined support for people with dementia and carers versus regular day care on

behaviour and mood of persons with dementia: results from a multi-centre implementation study. Int J Geriatr Psychiatry 2004; 19:673-684

6. Finnema E, Droes RM, Ettema T, et al: The effect of integrated emotion-oriented care versus usual care on elderly persons with dementia in

the nursing home and on nursing assistants: a randomized clinical trial. Int J Geriatr Psychiatry 2005; 20:330-343


8. Diesfeldt HFA: Test-retest data for the BOP, a Dutch geriatric rating scale: The significance of individual change. Gerontologie. 1981;

12:212-217

9. Hall L, Hare J: Video respite(M) for cognitively impaired persons in nursing homes American Journal of Alzheimer's Disease & Other

Dementias 1997; 12:117-121

10. Hanley IG, McGuire RJ, Boyd WD: Reality orientation and dementia: A controlled trial of two approaches. Br J Psychiatry. 1981; 138:10-14

11. Rands G: Review: reality orientation improves cognitive functioning and behaviour in dementia. Evidence-Based Mental Health 1999; 2:17

12. Plutchik R, Conte H, Lieberman M, et al: Reliability and validity of a scale for assessing the functioning of geriatric patients. J Am Geriatr

Soc 1970; 18:491-500

13. Lai CKY, Chi I, Kayser-Jones J: A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing

home residents with dementia. Int Psychogeriatr 2004; 16:33-49

32

14. Byar DP, Simon RM, Friedewald WT, et al: Randomized clinical trials. Perspectives on some recent ideas. N Engl J Med 1976; 295:74-80

15. Schroll M, Jonsson PV, Mor V, et al: An international study of social engagement among nursing home residents. Age and Ageing. 1997;

26:55-59

16. Mor V, Branco K, Fleishman J, et al: The structure of social engagement among nursing home residents. J Gerontol B Psychol Sci Soc Sci.

1995; 50:1-8

17. Schrijnemaekers V, van Rossum E, Candel M, et al: Effects of emotion-oriented care on elderly people with cognitive impairment and

behavioral problems. Int J Geriatr Psychiatry 2002; 17:926-937

18. Finnema EJ, Droes RM, Van der Kooij CH, et al: The design of a large-scale experimental study into the effect of emotion-oriented care on

demented elderly and professional carers in nursing homes. Arch Gerontol Geriatr 1998; 27:193-200

19. Feil N: Validation: Techniques for communicating with confused old-old persons and improving their quality of life. Topics in Geriatric

Rehabilitation 1996; 11:34-42

20. Tabourne CE: The effects of a life review program on disorientation, social interaction and self-esteem of nursing home residents. Int J

Aging Hum Dev 1995; 41:251-266

21. Tadaka E, Kanagawa K: Effects of reminiscence group in elderly people with Alzheimer disease and vascular dementia in a community

setting. Geriatrics and Gerontology International 2007; 7:167-173

22. Helmes E, Csapo KG, Short JA: Standardization and validation of the Multidimensional Observation Scale for Elderly Subjects (MOSES). J

Gerontol 1987; 42:395-405

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Word Count tables: 7,971 - Lippincott Williams & Wilkinsdownload.lww.com/.../AJGP/A/AJGP_2011_07_07_BROD… · Web viewFollow-up Number Method of randomization Blinding of raters