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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
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:
- improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
- improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
- improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.
详细描述
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:
- improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia.
- improving the affect, positive aspects of caregiving, and HRQL of family caregivers.
- improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor who is blinded to group allocation will collect the posttest data
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Buddy-Up Dyadic Physical Activity (BUDPA) program (Other)
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
干预措施: Usual care with waitlist control (Other)
结局指标
主要结局
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
时间窗: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
The International Positive and Negative Affect Schedule - Short-Form (PNAS-SF)
时间窗: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate caregiver's mood status, scales from 20 to 100, with higher score indicating higher mood change
The Color-Trails Test (CTT)
时间窗: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions.
The digit span-forward and backward test
时间窗: baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42)
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
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
时间窗: 24-weeks (T2) after baseline
evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
Quality of Life-Alzheimer's Disease (QoL-AD)
时间窗: 24-weeks (T2) after baseline
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
The Neuro-psychiatric Inventory (NPI)
时间窗: 24-weeks (T2) after baseline
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
The Zarit Burden Interview (ZBI)
时间窗: 24-weeks (T2) after baseline
evaluate the perceived caregiving burden among the caregivers, scales from 0 to 88, with higher score indicating higher perceived burden of caregivers
The International Positive and Negative Affect Schedule - Short-Form (PNAS-SF)
时间窗: 24-weeks (T2) after baseline
evaluate caregiver's mood status, scales from 20 to 100, with higher score indicating higher mood change
The Color-Trails Test (CTT)
时间窗: 24-weeks (T2) after baseline
evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions.
The digit span-forward and backward test
时间窗: 24-weeks (T2) after baseline
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
次要结局
- Medical Outcomes Study Short Form Health Survey (SF-12)(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)(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)(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)(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)(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)(baseline (T0), immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42))
- Medical Outcomes Study Short Form Health Survey (SF-12)(24-weeks (T2) after baseline)
- The Dyadic Relationship Scale (DRS)(24-weeks (T2) after baseline)
- Positive Aspect of Caregiving Scale (PAC)(24-weeks (T2) after baseline)
研究者
Prof. Yu, Doris Sau Fung
Professor
The University of Hong Kong