A Phone Intervention for Family Dementia Caregivers in Vietnam

Sponsor

University of California, Davis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05481320

Collaborator

University of Minnesota (Other), Vietnam National Geriatric Hospital (Other)

Enrollment

Location

Arms

5.7

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: REACH VN Phone Intervention Behavioral: Enhanced Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

A Phone Intervention for Family Dementia Caregivers in Vietnam

Anticipated Study Start Date :

Aug 10, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: REACH VN Phone Intervention 4-6 intervention sessions delivered via phone over the course of 1-3 months.
Placebo Comparator: Enhanced control A single phone session focused on education about the nature of dementia.	Behavioral: Enhanced Control A single phone session providing education about dementia.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: REACH VN Phone Intervention

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

Placebo Comparator: Enhanced control

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

Behavioral: Enhanced Control

A single phone session providing education about dementia.

Outcome Measures

Primary Outcome Measures

Zarit Burden Interview-6 (ZBI-6) [Baseline, 3 months]
Change in caregiver burden related to caregiving

Secondary Outcome Measures

Patient Health Questionnaire-4 (PHQ-4) [Baseline, 3 months]
Change in caregiver psychological distress

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 5 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