Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2024-02-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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REACH VN

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.

Group Type EXPERIMENTAL

REACH VN

Intervention Type BEHAVIORAL

4-6 sessions delivered over the course of 2-3 months.

Enhanced control

A single session focused on education about the nature of dementia.

Group Type PLACEBO_COMPARATOR

Enhanced control

Intervention Type BEHAVIORAL

A single session providing education about dementia

Interventions

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REACH VN

4-6 sessions delivered over the course of 2-3 months.

Intervention Type BEHAVIORAL

Enhanced control

A single session providing education about dementia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.