A Phone Intervention for Family Dementia Caregivers in Vietnam

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phone Intervention for Family Dementia Caregivers in Vietnam

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: REACH VN Phone Intervention
* Behavioral: Enhanced Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH VN Phone Intervention<br>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. | Behavioral: REACH VN Phone Intervention<br>* 4-6 intervention sessions delivered via phone over the course of 1-3 months.<br>|
| Placebo Comparator: Enhanced control<br>A single phone session focused on education about the nature of dementia. | Behavioral: Enhanced Control<br>* A single phone session providing education about dementia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zarit Burden Interview-6 (ZBI-6) | Change in caregiver burden related to caregiving | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-4 (PHQ-4) | Change in caregiver psychological distress | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, family caregiving, phone intervention, non-pharmacological intervention, dementia caregivers