Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542317
• Other study ID #: 1574137
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: February 27, 2024

Study information

• Verified date: March 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• REACH VN
4-6 sessions delivered over the course of 2-3 months.
• Enhanced control
A single session providing education about dementia

Locations

Country	Name	City	State
Vietnam	Vietnam National Geriatric Hospital	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	National Geriatric Hospital, University of Minnesota

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zarit Burden Interview-12 (ZBI-12)	Change in caregiver burden related to caregiving	Baseline, 3 months, 6 months
Primary	Patient Health Questionnaire-4 (PHQ-4)	Change in caregiver psychological distress	Baseline, 3 months, 6 months
Secondary	Perceived Stress Scale	Change in caregiver psychosocial stress	Baseline, 3 months, 6 months
Secondary	Patient Health Questionnaire-15 (PHQ-15)	Change in caregiver somatic symptoms	Baseline, 3 months, 6 months