A Phone Intervention for Family Dementia Caregivers in Vietnam

Dementia Clinical Trial

Official title:

A Phone Intervention for Family Dementia Caregivers in Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481320
• Other study ID #: 1937464
• Status: Completed
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: August 28, 2023

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• REACH VN Phone Intervention
4-6 intervention sessions delivered via phone over the course of 1-3 months.
• Enhanced Control
A single phone session providing education about dementia.

Locations

Country	Name	City	State
Vietnam	Vietnam National Geriatric Hospital	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	National Geriatric Hospital, University of Minnesota

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zarit Burden Interview-6 (ZBI-6)	Change in caregiver burden related to caregiving	Baseline, 3 months
Secondary	Patient Health Questionnaire-4 (PHQ-4)	Change in caregiver psychological distress	Baseline, 3 months