Clinical trial NCT05481320: A Phone Intervention for Family Dementia Caregivers in Vietnam
Official title: A Phone Intervention for Family Dementia Caregivers in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
family caregiving
phone intervention
non-pharmacological intervention
dementia caregivers
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: National Geriatric Hospital
name: National Institute on Aging (NIA)
First posted: 2022-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Zarit Burden Interview-6 (ZBI-6)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Geriatric Hospital
Study officials:
References: