A Phone Intervention for Family Dementia Caregivers in Vietnam

University of California (UC) Davis

Status: Completed

Conditions: Dementia

Treatments: Behavioral: Enhanced Control; Behavioral: REACH VN Phone Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05481320

1937464

R01AG064688 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

REACH VN Phone Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: REACH VN Phone Intervention

Enhanced control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Control