A cluster randomized controlled trial to test the feasibility and preliminary effectiveness of a family dementia caregiver intervention in Vietnam: The REACH VN study protocol

BACKGROUND: Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA) is an evidence-based intervention supporting family dementia caregivers that has been shown to improve caregiver outcomes for culturally diverse populations in the United States. However, this model has not been tested in low- and middle-income countries (LMICs) including Vietnam, where community-based psychosocial interventions are urgently needed. The objectives of this study are to assess the feasibility and preliminary effectiveness of a culturally adapted version of the Resources for Enhancing All Caregivers Health in Vietnam (REACH VN). METHODS: A cluster randomized controlled trial (RCT) will be conducted over a 6-month period in Soc Son district located in Hanoi. An expected sample of 10 to 12 communes, representing approximately 50 dementia primary caregivers, will be randomized to either the REACH VN intervention or an enhanced control condition. Inclusion criteria for the caregiver include age ≥18, family member who provides the most day-to-day care for person with dementia, and a total score for the brief (4 item) Zarit Burden Scale of ≥6. Over the course of 2 to 3 months, each participant in the intervention group will receive the REACH VN intervention comprised of 4 core sessions on problem solving, mood management/cognitive restructuring, stress management, and communication, and up to 2 additional sessions based on caregiver's needs. The enhanced control group will receive a single session that provides verbal and written information on dementia. Caregiver outcomes will be assessed at baseline (i.e., time of enrolment) and 3 months. The feasibility will be assessed with regard to recruitment, retention, treatment adherence, treatment fidelity, and assessment processes. For preliminary effectiveness, we will examine caregiver burden as the primary outcome and changes in caregiver depressive symptoms and in Alzheimer disease knowledge as secondary outcomes. DISCUSSION: This is the first study to test community-based family dementia caregiver intervention in Vietnam. Results from this study will provide the foundation for a larger effectiveness trial and broader dissemination in Vietnam and may help inform efforts to develop similar community-based family dementia caregiver support programs in other LMICs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03587974. Published online July 16, 2018