Back to resultsEfficacy of a Dementia Family Caregiver Support Intervention in Vietnam
Primary Purpose
Dementia
Status
Active
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
REACH VN
Enhanced control
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Family caregiving
Eligibility Criteria
Inclusion Criteria:
- To be eligible for the cluster RCT, the family member will need to be the identified adult (age 18 and above) primary caregiver (i.e. the person spending who provides the most time day-to-day providing care) to an older adult with dementia who is living in the community. In the event that the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) to the older adult with dementia will be eligible.
- Caregivers will need to score ≥ 6 on the Zarit Burden Inventory 4-item version.
- All participants will be living in designated clusters in Hai Duong, Vietnam.
- To be eligible, clusters will have a minimum of 5 participants and a maximum of 15 participants. Clusters will be defined as geographic areas serving local health stations.
Exclusion Criteria:
- Significant cognitive impairment or sensory deficit.
Sites / Locations
- Vietnam National Geriatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
REACH VN
Enhanced control
Arm Description
A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months.
A single session focused on education about the nature of dementia.
Outcomes
Primary Outcome Measures
Zarit Burden Interview-12 (ZBI-12)
Change in caregiver burden related to caregiving
Patient Health Questionnaire-4 (PHQ-4)
Change in caregiver psychological distress
Secondary Outcome Measures
Perceived Stress Scale
Change in caregiver psychosocial stress
Patient Health Questionnaire-15 (PHQ-15)
Change in caregiver somatic symptoms
Full Information
NCT ID
NCT04542317
First Posted
August 31, 2020
Last Updated
August 30, 2023
Sponsor
University of California, Davis
Collaborators
National Geriatric Hospital, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04542317
Brief Title
Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam
Official Title
Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Geriatric Hospital, University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in Vietnam.
Detailed Description
The objective of this study is to conduct a cluster randomized controlled trial (RCT) to test the efficacy of a psychosocial intervention to support Alzheimer's family caregivers in Vietnam. The cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower psychological distress and lower caregiver burden compared with those in the control group (primary outcomes). In addition, we will conduct secondary analyses to examine whether the intervention group has lower perceived stress and somatic symptoms. Exploratory analyses will be conducted to determine if intervention effects are mediated by caregiver self-efficacy or knowledge gain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Family caregiving
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The active treatment is REACH VN, a culturally adapted version of REACH VA, a multi-component dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REACH VN
Arm Type
Experimental
Arm Description
A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months.
Arm Title
Enhanced control
Arm Type
Placebo Comparator
Arm Description
A single session focused on education about the nature of dementia.
Intervention Type
Behavioral
Intervention Name(s)
REACH VN
Intervention Description
4-6 sessions delivered over the course of 2-3 months.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced control
Intervention Description
A single session providing education about dementia
Primary Outcome Measure Information:
Title
Zarit Burden Interview-12 (ZBI-12)
Description
Change in caregiver burden related to caregiving
Time Frame
Baseline, 3 months, 6 months
Title
Patient Health Questionnaire-4 (PHQ-4)
Description
Change in caregiver psychological distress
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
Change in caregiver psychosocial stress
Time Frame
Baseline, 3 months, 6 months
Title
Patient Health Questionnaire-15 (PHQ-15)
Description
Change in caregiver somatic symptoms
Time Frame
Baseline, 3 months, 6 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible for the cluster RCT, the family member will need to be the identified adult (age 18 and above) primary caregiver (i.e. the person spending who provides the most time day-to-day providing care) to an older adult with dementia who is living in the community. In the event that the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) to the older adult with dementia will be eligible.
Caregivers will need to score ≥ 6 on the Zarit Burden Inventory 4-item version.
All participants will be living in designated clusters in Hai Duong, Vietnam.
To be eligible, clusters will have a minimum of 5 participants and a maximum of 15 participants. Clusters will be defined as geographic areas serving local health stations.
Exclusion Criteria:
- Significant cognitive impairment or sensory deficit.
Facility Information:
Facility Name
Vietnam National Geriatric Hospital
City
Hanoi
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35534904
Citation
Tran D, Nguyen H, Pham T, Nguyen AT, Nguyen HT, Nguyen NB, Nguyen BH, Harvey D, Gitlin L, Hinton L. Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam. Trials. 2022 May 9;23(1):377. doi: 10.1186/s13063-022-06228-6.
Results Reference
derived
Learn more about this trial
Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam
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