A Phone Intervention for Family Dementia Caregivers in Vietnam

NCT ID: NCT05481320

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-27
• Study Completion Date: 2023-08-28

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

REACH VN Phone Intervention

A 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.

Group Type: EXPERIMENTAL

REACH VN Phone Intervention

Intervention Type: BEHAVIORAL

4-6 intervention sessions delivered via phone over the course of 1-3 months.

Enhanced control

A single phone session focused on education about the nature of dementia.

Group Type: PLACEBO_COMPARATOR

Enhanced Control

Intervention Type: BEHAVIORAL

A single phone session providing education about dementia.

Interventions

REACH VN Phone Intervention

4-6 intervention sessions delivered via phone over the course of 1-3 months.

Intervention Type: BEHAVIORAL

Enhanced Control

A single phone session providing education about dementia.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

National Geriatric Hospital

OTHER_GOV

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vietnam National Geriatric Hospital

Hanoi, , Vietnam

Countries

Vietnam

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AG064688

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1937464

Identifier Type: -

Identifier Source: org_study_id