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The global cost of dementia is over 818 billion, and a further rise is expected in the next decade. While family caregiving is the backbone of the formal care service, promoting "living well with dementia" needs to extend to a dyadic perspective to address the needs of persons with dementia (PwD) and their caregivers. Unique to dementia caregiving, imbalanced exchange in the assistance, interaction, relationship and autonomy between the partners in a care dyad always challenges their social interaction and relationships. Such eroding dyadic dynamics not only worsens the mental health of caregivers, but also compromises the quality of caregiving, fosters more dementia deterioration, and eventually complicates the caregiving process. Nevertheless, least attention is directed to dyadic dynamics in promoting living well with dementia. Partner exercise is designed in a way which requires collaboration of two members to enable the workout of each other. In addition to the benefits of exercise on dementia symptom control and caregiver's stress management, partner exercise provides a meaningful encounter to encourage reciprocity, collaboration and relationship closeness within the care dyad.
This is a sequential mixed-method study including a multicenter RCT to evaluate the effects of the 16-week enhanced BUDPA and a descriptive qualitative study to explore the care dyad's overall engagement experience and perceptions. The study will be conducted in 8 elderly community centres operated by four NGOs.
The primary aim of the study investigates the effects of a 16-week enhanced BUDPA program on the health and dyadic dynamic of the persons with dementia and their family caregivers (Objective 1-3). The secondary aim explores dyads' overall experience in program engagement, particularly in terms of perceived benefits, challenges, and experience in self-directed practice (Objective 4). The primary outcomes include PwD's cognitive function and caregivers' mood status.
We hypothesize that the 16-week enhanced BUDPA program will be more effective than usual care immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) in:
The global cost of dementia is over 818 billion, and a further rise is expected in the next decade. While family caregiving is the backbone of the formal care service, promoting "living well with dementia" needs to extend to a dyadic perspective to address the needs of persons with dementia (PwD) and their caregivers. Unique to dementia caregiving, imbalanced exchange in the assistance, interaction, relationship and autonomy between the partners in a care dyad always challenges their social interaction and relationships. Such eroding dyadic dynamics not only worsens the mental health of caregivers, but also compromises the quality of caregiving, fosters more dementia deterioration, and eventually complicates the caregiving process. Nevertheless, least attention is directed to dyadic dynamics in promoting living well with dementia. Partner exercise is designed in a way which requires collaboration of two members to enable the workout of each other. In addition to the benefits of exercise on dementia symptom control and caregiver's stress management, partner exercise provides a meaningful encounter to encourage reciprocity, collaboration and relationship closeness within the care dyad.
This is a sequential mixed-method study including a multicenter RCT to evaluate the effects of the 16-week enhanced BUDPA and a descriptive qualitative study to explore the care dyad's overall engagement experience and perceptions. The study will be conducted in 8 elderly community centres operated by four NGOs.
The primary aim of the study investigates the effects of a 16-week enhanced BUDPA program on the health and dyadic dynamic of the persons with dementia and their family caregivers. The secondary aim explores dyads' overall experience in program engagement, particularly in terms of perceived benefits, challenges, and experience in self-directed practice. The primary outcomes include PwD's cognitive function and caregivers' mood status.
We hypothesize that the 16-week enhanced BUDPA program will be more effective than usual care immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) in:
This sequential mixed-method study will recruit 236 care dyads (including 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUDPA program | Experimental | 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 waitlist control | Other | The usual care such as dementia or caregiver support services, will be provided by the elderly community centres with a waitlist execute after the last assessment time point T3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buddy-Up Dyadic Physical Activity (BUDPA) program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog) | evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function. | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| The International Positive and Negative Affect Schedule - Short-Form (PNAS-SF) | evaluate caregiver's mood status, scales from 20 to 100, with higher score indicating higher mood change | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| The Color-Trails Test (CTT) | evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions. | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| The digit span-forward and backward test | evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Outcomes Study Short Form Health Survey (SF-12) | evaluates the health-related quality of life (HRQL) of the family caregiver, scales from 12 to 60, with higher score indicating better HRQL | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
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Eligibility for person with dementia (PwD) includes i) a confirmed diagnosis of dementia and ii) an HK-MoCA score of 8-19 to indicate mild to early moderate dementia.
The caregivers will have to i) live with the participant with dementia ii) self-identify as the primary family caregiver iii) providing care for ≥ 4 hours/day iv) has a smartphone for FaceTime
The exclusion criteria are i) engaging in ≥60 min/week of moderate or vigorous exercise in the past six months ii) having acute muscular-skeletal problems, cerebro-cardio-respiratory disease or condition contradictory to exercise training
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SAU FUNG DORIS YU, PhD | Contact | 852-39176319 | dyu1@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| SAU FUNG DORIS YU, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32838809 | Background | 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. | |
| 28798612 | Background | 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. |
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There is not a plan to make individual participant data (IPD) available.
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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-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.
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The outcome assessor who is blinded to group allocation will collect the posttest data
|
|
| Usual care with waitlist control | Other | The usual care such as dementia or caregiver support services, will be provided by the elderly community centres with a waitlist execute after the last assessment time point T3 |
|
| The Dyadic Relationship Scale (DRS) |
evaluate the dyadic dynamic in terms of negative relationship strain and positive interaction within the care dyad, scales from 11 to 44, with higher score indicating higher levels of dyadic strain |
| baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| Positive Aspect of Caregiving Scale (PAC) | evaluate caregiver's gain in terms of self -affirmation and outlook on life, scales from 0 to 44, with higher scores indicating more positive caregiving gain | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| Quality of Life-Alzheimer's Disease (QoL-AD) | evaluate the health-related quality of life (HR) covering physical, functional, psychosocial, interpersonal, and environmental status of the patient with dementia, scales 13 to 52, with higher score indicating better HRQL | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| The Neuro-psychiatric Inventory (NPI) | evaluate the neuro-psychiatric symptoms of the patient with dementia reported by the caregiver, scales from 12 to 96 with higher scores indicating higher severity | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| The Zarit Burden Interview (ZBI) | evaluate the perceived caregiving burden among the caregivers, scales from 0 to 88, with higher score indicating higher perceived burden of caregivers | baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) |
| 27458254 | Background | 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. |
| 22548375 | Background | 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. |
| 23097740 | Background | 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. |
| 25161263 | Background | 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. |
| 30536383 | Background | 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. |
| 31843427 | Background | 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. |
| 34261027 | Background | 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. |
| 23970459 | Background | 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. |
| 11536346 | Background | 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. |
| 18515696 | Background | 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. |
| 30450924 | Background | 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. |
| 15892443 | Background | 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. |
| 18192628 | Background | 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. |
| 25488014 | Background | 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. |
| 21287107 | Background | 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. |
| 18352969 | Background | 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. |
| 12878896 | Background | Wolf ZR. Exploring the audit trail for qualitative investigations. Nurse Educ. 2003 Jul-Aug;28(4):175-8. doi: 10.1097/00006223-200307000-00008. |
| 31713252 | Background | 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. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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