Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers

Официальное название

Effects of Buddy-Up Dyadic Physical Activity Program on Health Outcomes and Social Dynamic of Persons With Dementia and Family Caregivers: A Mixed Method Randomized Controlled Trial

Обзор

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: 1. improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia. 2. improving the affect, positive aspects of caregiving, and HRQL of family caregivers. 3. improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.

Подробное описание

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:

1. improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia. 2. improving the affect, positive aspects of caregiving, and HRQL of family caregivers. 3. improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.

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.

Вмешательства

• Другое 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) Habituat
• Другое Usual care with waitlist control
  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

Первичные конечные точки

• Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)]

Вторичные конечные точки (6)

• Medical Outcomes Study Short Form Health Survey (SF-12) [Срок оценки: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)]
• The Dyadic Relationship Scale (DRS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The University of Hong Kong — Гонконг

Публикации

• 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. PMID 32838809
• 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. PMID 28798612
• 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. PMID 27458254
• 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. PMID 22548375
• 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. PMID 23097740
• 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. PMID 25161263
• 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. PMID 30536383
• 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. PMID 31843427

Идентификаторы

NCT: NCT06584110 · BUDPA-RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗