A Phone Intervention for Family Dementia Caregivers in Vietnam

NCT05481320 | Completed Results

• 2 other identifiers: 1937464R01AG064688
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

dementia; family caregiving; phone intervention; non-pharmacological intervention; dementia caregivers

Outcome Measures

Primary Outcomes (1)

• Zarit Burden Interview-6 (ZBI-6)

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

  Baseline, 3 months

Secondary Outcomes (1)

• Patient Health Questionnaire-4 (PHQ-4)

  Baseline, 3 months

Study Arms (2)

REACH VN Phone Intervention

EXPERIMENTAL

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.

Behavioral: REACH VN Phone Intervention

Enhanced control

PLACEBO COMPARATOR

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

Behavioral: Enhanced Control

Interventions

REACH VN Phone Intervention BEHAVIORAL

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

REACH VN Phone Intervention

Enhanced Control BEHAVIORAL

A single phone session providing education about dementia.

Enhanced control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• University of Minnesota: collaborator
• National Geriatric Hospital: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Vietnam National Geriatric Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Ladson Hinton, MD
• Organization: UC Davis

lwhinton@ucdavis.edu

9167343485

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The active treatment is a REACH VN phone intervention, a culturally adapted version of REACH VA, a multicomponent dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: October 27, 2022
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)