Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

University of California, Davis350 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

350

Conditions

Dementia

Interventions

REACH VNBEHAVIORAL

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

Enhanced controlBEHAVIORAL

A single session providing education about dementia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vietnam National Geriatric Hospital

Hanoi, Vietnam

Outcomes

Primary Outcomes

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.

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)

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.

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

Secondary Outcomes

Perceived Stress Scale (PSS-10)

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.

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

Patient Health Questionnaire-15 (PHQ-15)

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.

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

Data from ClinicalTrials.gov

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