Buddy-Up Dyadic Physical Activity Program for Persons with Dementia and Family Caregivers
NCT Number: NCT06584110
Acronym: BUDPA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Impairment, Mild|Dementia, Mild
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 222
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-06-30

Summary:
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 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 study aims to examine whether a 16-week theory-based partner exercise, named as Buddy-Up Dyadic Physical Activity (BUDPA) program, can improve dyadic dynamics and health outcomes of care dyads of mild to early-moderate dementia.

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.

Primary Outcome Measures: 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)|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., 16-weeks (T1) after baseline|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., 24-weeks (T2) after baseline|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)|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, 16-weeks (T1) after baseline|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, 24-weeks (T2) after baseline|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)|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, 16-weeks (T1) after baseline|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, 24-weeks (T2) after baseline|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)|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, 16-weeks (T1) after baseline|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, 24-weeks (T2) after baseline|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)|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, 16-weeks (T1) after baseline|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, 24-weeks (T2) after baseline|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)|The Color-Trails Test (CTT), evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions., 16-weeks (T1) after baseline|The Color-Trails Test (CTT), evaluate the complex attention, executive functions and task switching for the patient with dementia, higher score indicating poor functions., 24-weeks (T2) after baseline|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)|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, 16-weeks (T1) after baseline|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, 24-weeks (T2) after baseline
Secondary Outcome Measures: 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)|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, 16-weeks (T1) after baseline|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, 24-weeks (T2) after baseline|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)|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, 16-weeks (T1) after baseline|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, 24-weeks (T2) after baseline|Positive Aspect of Caregiving Scale (PAC), evaluate caregiver\&#39;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)|Positive Aspect of Caregiving Scale (PAC), evaluate caregiver\&amp;amp;#39;s gain in terms of self -affirmation and outlook on life, scales from 0 to 44, with higher scores indicating more positive caregiving gain, 16-weeks (T1) after baseline|Positive Aspect of Caregiving Scale (PAC), evaluate caregiver\&amp;amp;amp;#39;s gain in terms of self -affirmation and outlook on life, scales from 0 to 44, with higher scores indicating more positive caregiving gain, 24-weeks (T2) after baseline