Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
NCT ID: NCT06584110
Last Updated: 2025-06-22
Study Results
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Basic Information
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RECRUITING
NA
222 participants
INTERVENTIONAL
2024-10-01
2026-12-30
Brief Summary
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This sequential mixed-method study will recruit 111 care dyads from the elderly centers in Hong Kong. They will be randomized to receive the enhanced BUDPA program or usual care. The changes in the dyadic dynamics and health outcomes \[including symptom severity and health-related quality of life (HRQL) of persons with dementia; and affect, positive aspects of caregiving and HRQL of family caregivers\] between the two study groups from baseline (T0) to 16-weeks after baseline (T1) upon completion of the training , and at 24-weeks after baseline (T2). Data from outcome evaluation and interviews will be integrated to solicit a thorough understanding on the impact of BUDPA. This study marks the first attempt to use theory-driven dyadic intervention to enhance the dyadic dynamics and health outcomes of dementia care dyads. The project will advance the dyadic science in a dementia caregiving context and inform the development of evidence-based care model in dyadic fashion to promote living well with dementia in a caregiving context.
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Detailed Description
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This sequential mixed-method study will recruit 112 care dyads (people with Dementia (PwD) and family caregivers) from the elderly centers in Hong Kong. They will be randomized to receive the enhanced BUDPA program or usual care.
Subject:
For people with Dementia (PwD), the inclusion criteria are i) confirmed diagnosed of dementia ii) cognitive impairment as indicated by a Hong Kong-Montreal Cognitive Assessment (Hong Kong version; HK-MoCA) score of 8-19 to indicate mild to early moderate dementia will be recruited For family caregivers, the inclusion criteria are i) live together with the PwD ii) identify as the primary family caregivers of the PwD
The changes in the dyadic dynamics and health outcomes \[including symptom severity and health-related quality of life (HRQL) of persons with dementia; and affect, positive aspects of caregiving and HRQL of family caregivers\] between the two study groups from baseline (T0) to 16-weeks after baseline (T1) upon completion of the training , and at 24-weeks after baseline (T2).
1. For Pwd, 4 scales will be used, Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog), Color-Trails Test , Quality of Life-Alzheimer's Disease(QoL-AD), and The Dyadic Relationship Scale.
2. For family caregivers, measures the The Zarit Burden Interview (ZBI-C), The Neuro-psychiatric Inventory (NPI), The International Positive and Negative Affect Schedule - Short-Form (PANAS-SF 20 affect state), Medical Outcomes Study Short Form Health Survey (SF-12), The Dyadic Relationship Scale, and Positive Aspect of Caregiving Scale (PAC).
BUDPA program is an overall 16-week training which comprises three phases: the conditioning, consolidating and habituating phases.
i) Conditioning Phase (1st - 4th week) is the preparatory phase to introduce exercise movements in group training.
ii) Consolidating Phase (5th -12th week) is the training phase for group-based exercise. Each exercise training session will be followed by a 20-min debriefing and goal-setting session. Self-practice will be recorded on a simple logbook.
iii) habituating phase (13th-16th week) aims at supporting the care dyad to integrate the partner exercises into their daily lifestyle. A video call meeting with the care dyad in week 13 and week 15 will be scheduled to offer the support.
Data from outcome evaluation and interviews will be integrated to solicit a thorough understanding on the impact of BUDPA. This study marks the first attempt to use theory-driven dyadic intervention to enhance the dyadic dynamics and health outcomes of dementia care dyads. The project will advance the dyadic science in a dementia caregiving context and inform the development of evidence-based care model in dyadic fashion to promote living well with dementia in a caregiving context.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
i) Conditioning Phase (1st - 4th week) is the preparatory phase to introduce exercise movements in group training.
ii) Consolidating Phase (5th -12th week) is the training phase for group-based exercise. Each exercise training session will be followed by a 20-minutes debriefing and goal-setting session. Self-practice will be recorded on a simple logbook.
iii) Habituating phase (13th-16th week) aims at supporting the care dyad to integrate the partner exercises into their daily lifestyle. A video call meeting with the care dyad in week 13 and week 15 will be scheduled to offer the support.
TREATMENT
SINGLE
Study Groups
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BUDPA program
BUDPA program is an overall 16-week training which comprises three phases: the conditioning, consolidating and habituating phases.
i) Conditioning Phase (1st - 4th week) is the preparatory phase to introduce exercise movements in group training.
ii) Consolidating Phase (5th -12th week) is the training phase for group-based exercise. Each exercise training session will be followed by a 20-min debriefing and goal-setting session. Self-practice will be recorded on a simple logbook.
iii) Habituating phase (13th-16th week) aims at supporting the care dyad to integrate the partner exercises into their daily lifestyle. A video call meeting with the care dyad in week 13 and week 15 will be scheduled to offer the support.
Buddy-Up Dyadic Physical Activity (BUDPA) program
BUDPA program is an overall 16-week training which comprises three phases: the conditioning, consolidating and habituating phases.
i) Conditioning Phase (1st - 4th week) is the preparatory phase to introduce exercise movements in group training.
ii) Consolidating Phase (5th -12th week) is the training phase for group-based exercise. Each exercise training session will be followed by a 20-min debriefing and goal-setting session. Self-practice will be recorded on a simple logbook.
iii) Habituating phase (13th-16th week) aims at supporting the care dyad to integrate the partner exercises into their daily lifestyle. A video call meeting with the care dyad in week 13 and week 15 will be scheduled to offer the support.
Usual care
Usual care will be provided in the elderly centres. Usual care group will be put on a waiting list to receive the intervention (BUDPA program) after 24-weeks (T2) the second evaluation timepoint.
Usual care with waiting list
Usual care group will be put on a waiting list to receive the intervention (BUDPA program) after 24-weeks (T2) the second evaluation timepoint.
Interventions
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Buddy-Up Dyadic Physical Activity (BUDPA) program
BUDPA program is an overall 16-week training which comprises three phases: the conditioning, consolidating and habituating phases.
i) Conditioning Phase (1st - 4th week) is the preparatory phase to introduce exercise movements in group training.
ii) Consolidating Phase (5th -12th week) is the training phase for group-based exercise. Each exercise training session will be followed by a 20-min debriefing and goal-setting session. Self-practice will be recorded on a simple logbook.
iii) Habituating phase (13th-16th week) aims at supporting the care dyad to integrate the partner exercises into their daily lifestyle. A video call meeting with the care dyad in week 13 and week 15 will be scheduled to offer the support.
Usual care with waiting list
Usual care group will be put on a waiting list to receive the intervention (BUDPA program) after 24-weeks (T2) the second evaluation timepoint.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HK-MoCA score of 8-19 to indicate mild to early moderate dementia
* live with the PwD in the same household
* self-identified as the primary family caregiver of the PwD
* not self-identified as the primary family caregiver of the PwD
Exclusion Criteria
* acute muscular-skeletal problems, stroke or cardio-respiratory disease
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Locations
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The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Liu JD, You RH, Liu H, Chung PK. Chinese version of the international positive and negative affect schedule short form: factor structure and measurement invariance. Health Qual Life Outcomes. 2020 Aug 24;18(1):285. doi: 10.1186/s12955-020-01526-6.
Martin M, Peter-Wight M, Braun M, Hornung R, Scholz U. The 3-phase-model of dyadic adaptation to dementia: why it might sometimes be better to be worse. Eur J Ageing. 2009 Sep 29;6(4):291. doi: 10.1007/s10433-009-0129-5. eCollection 2009 Dec.
Laver K, Milte R, Dyer S, Crotty M. A Systematic Review and Meta-Analysis Comparing Carer Focused and Dyadic Multicomponent Interventions for Carers of People With Dementia. J Aging Health. 2017 Dec;29(8):1308-1349. doi: 10.1177/0898264316660414. Epub 2016 Jul 25.
Fauth E, Hess K, Piercy K, Norton M, Corcoran C, Rabins P, Lyketsos C, Tschanz J. Caregivers' relationship closeness with the person with dementia predicts both positive and negative outcomes for caregivers' physical health and psychological well-being. Aging Ment Health. 2012;16(6):699-711. doi: 10.1080/13607863.2012.678482.
Yu R, Chau PH, McGhee SM, Cheung WL, Chan KC, Cheung SH, Woo J. Trends in prevalence and mortality of dementia in elderly Hong Kong population: projections, disease burden, and implications for long-term care. Int J Alzheimers Dis. 2012;2012:406852. doi: 10.1155/2012/406852. Epub 2012 Oct 14.
Dassel KB, Carr DC. Does Dementia Caregiving Accelerate Frailty? Findings From the Health and Retirement Study. Gerontologist. 2016 Jun;56(3):444-50. doi: 10.1093/geront/gnu078. Epub 2014 Aug 26.
Stall NM, Kim SJ, Hardacre KA, Shah PS, Straus SE, Bronskill SE, Lix LM, Bell CM, Rochon PA. Association of Informal Caregiver Distress with Health Outcomes of Community-Dwelling Dementia Care Recipients: A Systematic Review. J Am Geriatr Soc. 2019 Mar;67(3):609-617. doi: 10.1111/jgs.15690. Epub 2018 Dec 10.
Law CK, Lam FM, Chung RC, Pang MY. Physical exercise attenuates cognitive decline and reduces behavioural problems in people with mild cognitive impairment and dementia: a systematic review. J Physiother. 2020 Jan;66(1):9-18. doi: 10.1016/j.jphys.2019.11.014. Epub 2019 Dec 13.
Baik D, Song J, Tark A, Coats H, Shive N, Jankowski C. Effects of Physical Activity Programs on Health Outcomes of Family Caregivers of Older Adults with Chronic Diseases: A Systematic Review. Geriatr Nurs. 2021 Sep-Oct;42(5):1056-1069. doi: 10.1016/j.gerinurse.2021.06.018. Epub 2021 Jul 11.
Yu HM, He RL, Ai YM, Liang RF, Zhou LY. Reliability and validity of the quality of life-Alzheimer disease Chinese version. J Geriatr Psychiatry Neurol. 2013 Dec;26(4):230-6. doi: 10.1177/0891988713500586. Epub 2013 Aug 22.
Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory (CNPI). Int J Geriatr Psychiatry. 2001 Aug;16(8):789-93. doi: 10.1002/gps.427.
Ko KT, Yip PK, Liu SI, Huang CR. Chinese version of the Zarit caregiver Burden Interview: a validation study. Am J Geriatr Psychiatry. 2008 Jun;16(6):513-8. doi: 10.1097/JGP.0b013e318167ae5b.
Moyle W, Jones C, Dwan T, Ownsworth T, Sung B. Using telepresence for social connection: views of older people with dementia, families, and health professionals from a mixed methods pilot study. Aging Ment Health. 2019 Dec;23(12):1643-1650. doi: 10.1080/13607863.2018.1509297. Epub 2018 Nov 17.
Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3.
Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.
Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.
Vallejo G, Fernandez MP, Livacic-Rojas PE, Tuero-Herrero E. Selecting the best unbalanced repeated measures model. Behav Res Methods. 2011 Mar;43(1):18-36. doi: 10.3758/s13428-010-0040-1.
Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
Wolf ZR. Exploring the audit trail for qualitative investigations. Nurse Educ. 2003 Jul-Aug;28(4):175-8. doi: 10.1097/00006223-200307000-00008.
Younas A, Pedersen M, Durante A. Characteristics of joint displays illustrating data integration in mixed-methods nursing studies. J Adv Nurs. 2020 Feb;76(2):676-686. doi: 10.1111/jan.14264. Epub 2019 Nov 25.
Other Identifiers
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BUDPA-RCT
Identifier Type: -
Identifier Source: org_study_id
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