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Completed

NCT Number: NCT04542317

Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vietnam National Geriatric Hospital

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REACH VN

Behavioral

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

Enhanced Control

Behavioral

A single session providing education about dementia

Primary outcomes

  1. Zarit Burden Interview-12 (ZBI-12)

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

    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.

  2. Patient Health Questionnaire-4 (PHQ-4)

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

    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.

Secondary outcomes

  1. Perceived Stress Scale (PSS-10)

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

    In the Perceived Stress Scale-10 (PSS-10), caregivers were asked to rate on a scale of 0 (never) to 4 (very often) how often they have felt a certain way (e.g., been upset because of something that happened unexpectedly) within the past month (total score range: 0-40). A higher sore indicates a higher perceived stress.

  2. Patient Health Questionnaire-15 (PHQ-15)

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

    In the Patient Health Questionnaire-15 (PHQ-15), caregivers were asked to rate on a 3-point scale (0 = not bothered at all, 1 = bothered a little, 2 = bothered a lot) how much they have been bothered by somatic symptoms (e.g., stomach pain, headaches) during the past seven days (total score range: 0-30). A higher score indicates a greater severity.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Geriatric Hospital
  • National Institute on Aging (NIA)
  • University of Minnesota

Registry information

Official study title

Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2020
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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