Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584110
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-31
Brief Title:
Buddy-Up Dyadic Physical Activity Program for Persons with Dementia and Family Caregivers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUDPA
Brief 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 caregivers 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
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
Detailed 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 caregivers 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 Alzheimers Disease Assessment Scale -Cognitive Subscale ADAS-Cog Color-Trails Test Quality of Life-Alzheimers DiseaseQoL-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
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 Alzheimers Disease Assessment Scale -Cognitive Subscale ADAS-Cog Color-Trails Test Quality of Life-Alzheimers DiseaseQoL-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None