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A Phone Intervention for Family Dementia Caregivers in Vietnam

Not Applicable
Completed
Conditions
Dementia
Interventions
Behavioral: Enhanced Control
Behavioral: REACH VN Phone Intervention
Registration Number
NCT05481320
Lead Sponsor
University of California, Davis
Brief Summary

This is a cluster randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving 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 examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN (Resources for Enhancing Alzheimer's Caregiver Health in Vietnam), a psychosocial culturally adapted Alzheimer's family caregiving intervention that will be delivered over the phone with an enhanced control as the comparison. The pilot cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower caregiver burden (primary outcome) and lower depressive/anxiety symptoms (secondary outcome) compared with those in the control group.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • To be eligible to participate, a family member will need to be the identified adult (i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) caregiver (i.e., the person who provides the most time day-to-day care) to an older adult (i.e., age 60 and above) with dementia living in the community. If the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 h/day) to an older adult with dementia will be eligible to participate.
  • In addition, caregivers will need to score ≥ 6 on the Zarit Burden Interview-4 (ZBI-4).
  • All participants will be living in clusters in Thach That District, a semi-rural area in Hanoi. Clusters will have a minimum of 3 participants and a maximum of 15 participants.
Exclusion Criteria
  • Caregivers with difficulties in the consent process due to cognitive impairment or severe sensory impairment (i.e., visual, hearing)
  • Caregivers don't have access to phone
  • Individuals who are not yet adults (i.e., infants, children, teenagers)
  • Prisoners

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Enhanced controlEnhanced ControlA single phone session focused on education about the nature of dementia.
REACH VN Phone InterventionREACH VN Phone InterventionA multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.
Primary Outcome Measures
NameTimeMethod
Zarit Burden Interview-6 (ZBI-6)Baseline, 3 months

Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.

Secondary Outcome Measures
NameTimeMethod
Patient Health Questionnaire-4 (PHQ-4)Baseline, 3 months

Change in caregiver psychological distress (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a greater level of psychological distress.

Trial Locations

Locations (1)

Vietnam National Geriatric Hospital

🇻🇳

Hanoi, Vietnam

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