Clinical trial NCT04542317: Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam
Official title: Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Family caregiving
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Geriatric Hospital
name: University of Minnesota
name: National Institute on Aging (NIA)
First posted: 2020-09-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Zarit Burden Interview-12 (ZBI-12)
timeFrame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Geriatric Hospital
Study officials:
References:
citation: Tran D, Nguyen H, Pham T, Nguyen AT, Nguyen HT, Nguyen NB, Nguyen BH, Harvey D, Gitlin L, Hinton L. 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.