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. 2022 May 9;23(1):377.
doi: 10.1186/s13063-022-06228-6.

Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam

Duyen Tran  1 , Huong Nguyen  2 , Thang Pham  3   4 , Anh T Nguyen  3   4 , Hung T Nguyen  3   4 , Ngoc B Nguyen  3 , Bien H Nguyen  5 , Danielle Harvey  6 , Laura Gitlin  7 , Ladson Hinton  8
Affiliations

Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam

Duyen Tran et al. Trials. .

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.gov NCT04542317 . Registered on 9 September 2020.

Keywords: Alzheimer’s; Dementia; Family caregiving; Global health; Non-pharmacological caregiving intervention; Vietnam.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram of REACH VN
Fig. 2
Fig. 2
REACH VN impacts on caregiver outcomes and potential intervention mechanisms
Fig. 3
Fig. 3
Participant timeline
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