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; Huong Nguyen; Thang Pham; Anh T Nguyen; Hung T Nguyen; Ngoc B Nguyen; Bien H Nguyen; Danielle Harvey; Laura Gitlin; Ladson Hinton

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

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

Authors

Duyen Tran¹, Huong Nguyen², Thang Pham^{3

4}, Anh T Nguyen^{3

4}, Hung T Nguyen^{3

4}, Ngoc B Nguyen³, Bien H Nguyen⁵, Danielle Harvey⁶, Laura Gitlin⁷, Ladson Hinton⁸

Affiliations

¹ Department of Neurology, University of California, Davis, Sacramento, CA, USA.
² School of Nursing, University of Minnesota, Minneapolis, MN, USA.
³ National Geriatric Hospital, Hanoi, Vietnam.
⁴ Hanoi Medical University, Hanoi, Vietnam.
⁵ Hai Duong Provincial General Hospital, Hai Duong, Vietnam.
⁶ Department of Public Health Sciences, University of California, Davis, Davis, CA, USA.
⁷ College of Nursing and Health Professions, Drexel University, Philadelphia, PA, USA.
⁸ Department of Psychiatry and Behavioral Sciences, University of California, Davis, 2230 Stockton Blvd, Sacramento, CA, 95817, USA. lwhinton@ucdavis.edu.

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.

Publication types

Clinical Trial Protocol

MeSH terms

Adolescent
Aged
Alzheimer Disease* / diagnosis
Alzheimer Disease* / epidemiology
Alzheimer Disease* / therapy
Caregivers* / psychology
Humans
Quality of Life
Randomized Controlled Trials as Topic
Vietnam

Associated data

ClinicalTrials.gov/NCT04542317

Abstract

Publication types

MeSH terms

Associated data

Grants and funding