Abstract
Background
Alzheimer’s disease and related dementias (AD/ADRD) are a public health challenge for Vietnam because of its rapidly aging population. However, very few community-based programs exist to support people living with AD/ADRD and their family caregivers. Resources for Enhancing Alzheimer’s Caregiver Health in Vietnam (REACH VN) is a culturally adapted family caregiver intervention shown in a pilot study to be feasible and promising in terms of preliminary efficacy. We describe the protocol for a larger cluster randomized controlled trial (RCT) to test the efficacy of REACH VN among family caregivers of people living with dementia in a semi-rural area outside of Hanoi, Vietnam.
Methods
Thirty-two clusters with approximately 350 caregivers will be randomized to either REACH VN intervention or enhanced usual care. REACH VN is a multicomponent intervention delivered in-home or by phone over the course of 2 to 3 months. To be eligible, family caregivers need to be ≥18 years old, be the person who provides the most day-to-day care for people living with dementia, and have a score ≥ 6 on the Zarit Burden Interview-4. The primary outcomes are caregiver burden (Zarit Burden Interview-12) and psychological distress (Patient Health Questionnaire-4). Secondary outcomes include caregiver somatic symptoms (Patient Health Questionnaire-15) and perceived stress (Perceived Stress Scale-10). These outcomes will be assessed at baseline, 3 months, and 6 months. Exploratory analyses to examine potential mediators of primary outcomes are also planned.
Discussion
To our knowledge, this is the first large-scale study to test the efficacy of a community-based family dementia caregiver intervention in Vietnam. Results from this study will help inform efforts to widely deliver the REACH VN intervention or similar community-based family dementia caregiver support programs in Vietnam and other low- and middle-income countries (LMIC).
Trial registration
ClinicalTrials.govNCT04542317. Registered on 9 September 2020
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Details
1 University of California, Davis, Department of Neurology, Sacramento, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)
2 University of Minnesota, School of Nursing, Minneapolis, USA (GRID:grid.17635.36) (ISNI:0000000419368657)
3 National Geriatric Hospital, Hanoi, Vietnam (GRID:grid.17635.36); Hanoi Medical University, Hanoi, Vietnam (GRID:grid.56046.31) (ISNI:0000 0004 0642 8489)
4 National Geriatric Hospital, Hanoi, Vietnam (GRID:grid.56046.31); Hanoi Medical University, Hanoi, Vietnam (GRID:grid.56046.31) (ISNI:0000 0004 0642 8489)
5 National Geriatric Hospital, Hanoi, Vietnam (GRID:grid.56046.31)
6 Hai Duong Provincial General Hospital, Hai Duong, Vietnam (GRID:grid.56046.31)
7 University of California, Davis, Department of Public Health Sciences, Davis, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)
8 Drexel University, College of Nursing and Health Professions, Philadelphia, USA (GRID:grid.166341.7) (ISNI:0000 0001 2181 3113)
9 University of California, Davis, Department of Psychiatry and Behavioral Sciences, Sacramento, USA (GRID:grid.27860.3b) (ISNI:0000 0004 1936 9684)




