Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

University of California (UC) Davis

Status: Completed

Conditions: Dementia

Treatments: Behavioral: REACH VN; Behavioral: Enhanced control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04542317

TR001860 (Other Grant/Funding Number)

1574137

R01AG064688 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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350 participants in 2 patient groups, including a placebo group

REACH VN

Experimental group

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.

Treatment:

Behavioral: REACH VN

Enhanced control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Enhanced control