Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
REACH VN	REACH VN	A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months.
Enhanced control	Enhanced control	A single session focused on education about the nature of dementia.

Primary Outcome Measures

Name	Time	Method
Zarit Burden Interview-12 (ZBI-12)	Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months	The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden.
Patient Health Questionnaire-4 (PHQ-4)	Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months	Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS-10)	Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months	In the Perceived Stress Scale-10 (PSS-10), caregivers were asked to rate on a scale of 0 (never) to 4 (very often) how often they have felt a certain way (e.g., been upset because of something that happened unexpectedly) within the past month (total score range: 0-40). A higher sore indicates a higher perceived stress.
Patient Health Questionnaire-15 (PHQ-15)	Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months	In the Patient Health Questionnaire-15 (PHQ-15), caregivers were asked to rate on a 3-point scale (0 = not bothered at all, 1 = bothered a little, 2 = bothered a lot) how much they have been bothered by somatic symptoms (e.g., stomach pain, headaches) during the past seven days (total score range: 0-30). A higher score indicates a greater severity.