Back to resultsA Phone Intervention for Family Dementia Caregivers in Vietnam
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
REACH VN Phone Intervention
Enhanced Control
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring dementia, family caregiving, phone intervention, non-pharmacological intervention, dementia caregivers
Eligibility Criteria
Inclusion Criteria:
- To be eligible to participate, a family member will need to be the identified adult (i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) caregiver (i.e., the person who provides the most time day-to-day care) to an older adult (i.e., age 60 and above) with dementia living in the community. If the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 h/day) to an older adult with dementia will be eligible to participate.
- In addition, caregivers will need to score ≥ 6 on the Zarit Burden Interview-4 (ZBI-4).
- All participants will be living in clusters in Thach That District, a semi-rural area in Hanoi. Clusters will have a minimum of 5 participants and a maximum of 15 participants.
Exclusion Criteria:
- Caregivers with difficulties in the consent process due to cognitive impairment or severe sensory impairment (i.e., visual, hearing)
- Caregivers don't have access to phone
- Individuals who are not yet adults (i.e., infants, children, teenagers)
- Prisoners
Sites / Locations
- Vietnam National Geriatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
REACH VN Phone Intervention
Enhanced control
Arm Description
A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.
A single phone session focused on education about the nature of dementia.
Outcomes
Primary Outcome Measures
Zarit Burden Interview-6 (ZBI-6)
Change in caregiver burden related to caregiving
Secondary Outcome Measures
Patient Health Questionnaire-4 (PHQ-4)
Change in caregiver psychological distress
Full Information
NCT ID
NCT05481320
First Posted
July 28, 2022
Last Updated
August 30, 2023
Sponsor
University of California, Davis
Collaborators
University of Minnesota, National Geriatric Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05481320
Brief Title
A Phone Intervention for Family Dementia Caregivers in Vietnam
Official Title
A Phone Intervention for Family Dementia Caregivers in Vietnam
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
August 28, 2023 (Actual)
Study Completion Date
August 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of Minnesota, National Geriatric Hospital
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 examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving 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 examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN (Resources for Enhancing Alzheimer's Caregiver Health in Vietnam), a psychosocial culturally adapted Alzheimer's family caregiving intervention that will be delivered over the phone with an enhanced control as the comparison. The pilot cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower caregiver burden (primary outcome) and lower depressive/anxiety symptoms (secondary outcome) compared with those in the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, family caregiving, phone intervention, non-pharmacological intervention, dementia caregivers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The active treatment is a REACH VN phone intervention, a culturally adapted version of REACH VA, a multicomponent dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REACH VN Phone Intervention
Arm Type
Experimental
Arm Description
A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.
Arm Title
Enhanced control
Arm Type
Placebo Comparator
Arm Description
A single phone session focused on education about the nature of dementia.
Intervention Type
Behavioral
Intervention Name(s)
REACH VN Phone Intervention
Intervention Description
4-6 intervention sessions delivered via phone over the course of 1-3 months.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Control
Intervention Description
A single phone session providing education about dementia.
Primary Outcome Measure Information:
Title
Zarit Burden Interview-6 (ZBI-6)
Description
Change in caregiver burden related to caregiving
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-4 (PHQ-4)
Description
Change in caregiver psychological distress
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible to participate, a family member will need to be the identified adult (i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) caregiver (i.e., the person who provides the most time day-to-day care) to an older adult (i.e., age 60 and above) with dementia living in the community. If the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 h/day) to an older adult with dementia will be eligible to participate.
In addition, caregivers will need to score ≥ 6 on the Zarit Burden Interview-4 (ZBI-4).
All participants will be living in clusters in Thach That District, a semi-rural area in Hanoi. Clusters will have a minimum of 3 participants and a maximum of 15 participants.
Exclusion Criteria:
Caregivers with difficulties in the consent process due to cognitive impairment or severe sensory impairment (i.e., visual, hearing)
Caregivers don't have access to phone
Individuals who are not yet adults (i.e., infants, children, teenagers)
Prisoners
Facility Information:
Facility Name
Vietnam National Geriatric Hospital
City
Hanoi
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phone Intervention for Family Dementia Caregivers in Vietnam
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