Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Behavioral: REACH VN
* Behavioral: Enhanced control


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH VN<br>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<br>* 4-6 sessions delivered over the course of 2-3 months.<br>|
| Placebo Comparator: Enhanced control<br>A single session focused on education about the nature of dementia. | Behavioral: Enhanced control<br>* A single session providing education about dementia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zarit Burden Interview-12 (ZBI-12) | Change in caregiver burden related to caregiving | Baseline, 3 months, 6 months | 
| Patient Health Questionnaire-4 (PHQ-4) | Change in caregiver psychological distress | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | Change in caregiver psychosocial stress | Baseline, 3 months, 6 months | 
| Patient Health Questionnaire-15 (PHQ-15) | Change in caregiver somatic symptoms | Baseline, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family caregiving