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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Enrolling

Conditions

Dementia, Mild
Cognitive Impairment, Mild

Treatments

Other: Buddy-Up Dyadic Physical Activity (BUDPA) program
Other: Usual care with waiting list

Study type

Interventional

Funder types

Other

Identifiers

NCT06584110
BUDPA-RCT

Details and patient eligibility

About

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.

Full description

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 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.

Enrollment

222 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for people with dementia (PwD):

  • confirmed diagnosis of dementia
  • HK-MoCA score of 8-19 to indicate mild to early moderate dementia

Inclusion Criteria for family caregivers:

  • live with the PwD in the same household
  • self-identified as the primary family caregiver of the PwD

Exclusion Criteria for people with dementia (PwD):

  • engaging in > 60 minutes per week of moderate or more vigorous exercise in the previous six months
  • acute muscular-skeletal problems, stroke or cardio-respiratory disease

Inclusion Criteria for family caregivers:

  • not self-identified as the primary family caregiver of the PwD

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

222 participants in 2 patient groups, including a placebo group

BUDPA program
Experimental group
Description:
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.
Treatment:
Other: Buddy-Up Dyadic Physical Activity (BUDPA) program
Usual care
Placebo Comparator group
Description:
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.
Treatment:
Other: Usual care with waiting list

Trial contacts and locations

1

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Central trial contact

SAU FUNG DORIS YU, PhD

Data sourced from clinicaltrials.gov

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