Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

NCT04542317 | Completed Results

• 3 other identifiers: 1574137R01AG064688TR001860
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Family caregiving

Outcome Measures

Primary Outcomes (2)

• Zarit Burden Interview-12 (ZBI-12)

  The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden.

  Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months

• Patient Health Questionnaire-4 (PHQ-4)

  Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity.

  Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months

Secondary Outcomes (2)

• Perceived Stress Scale (PSS-10)

  Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months

• Patient Health Questionnaire-15 (PHQ-15)

  Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months

Study Arms (2)

REACH VN

EXPERIMENTAL

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.

Behavioral: REACH VN

Enhanced control

PLACEBO COMPARATOR

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

Behavioral: Enhanced control

Interventions

REACH VN BEHAVIORAL

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

REACH VN

Enhanced control BEHAVIORAL

A single session providing education about dementia

Enhanced control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Significant cognitive impairment or sensory deficit.

Sponsors & Collaborators

• University of California, Davis: lead
• National Geriatric Hospital: collaborator
• University of Minnesota: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Vietnam National Geriatric Hospital

Hanoi, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 35534904 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Ladson Hinton, MD
• Organization: University of California, Davis

lwhinton@ucdavis.edu

9167343485

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 9, 2020
• Study Start: October 15, 2020
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)