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Clinical Trials/NCT05481320
NCT05481320
Completed
Not Applicable

A Phone Intervention for Family Dementia Caregivers in Vietnam

University of California, Davis1 site in 1 country60 target enrollmentOctober 27, 2022
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
University of California, Davis
Enrollment
60
Locations
1
Primary Endpoint
Zarit Burden Interview-6 (ZBI-6)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 27, 2022
End Date
August 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Zarit Burden Interview-6 (ZBI-6)

Time Frame: Baseline, 3 months

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

Secondary Outcomes

  • Patient Health Questionnaire-4 (PHQ-4)(Baseline, 3 months)

Study Sites (1)

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