N/A
Completed N=350
Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam
Source: ClinicalTrials.gov NCT04542317 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Zarit Burden Interview-12 (ZBI-12) — 21.4; 22.0; 20.1; 22.3 score on a scale
Summary
This is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in Vietnam.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Zarit Burden Interview-12 (ZBI-12) |
21.4; 22.0; 20.1; 22.3; 19.2; 22.4 | — |
| PRIMARY Patient Health Questionnaire-4 (PHQ-4) |
3.7; 3.8; 2.9; 4.4; 3.4; 3.8 | — |
| SECONDARY Perceived Stress Scale (PSS-10) |
13.7; 14.1; 11.9; 14.1; 12.7; 13.7 | — |
| SECONDARY Patient Health Questionnaire-15 (PHQ-15) |
9.0; 9.0; 7.6; 9.5; 8.2; 8.8 | — |
Eligibility Criteria
Inclusion Criteria
- To be eligible for the cluster RCT, the family member will need to be the identified adult (age 18 and above) primary caregiver (i.e. the person spending who provides the most time day-to-day providing care) to an older adult with dementia who is living in the community. In the event that the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) to the older adult with dementia will be eligible.
- Caregivers will need to score ≥ 6 on the Zarit Burden Inventory 4-item version.
- All participants will be living in designated clusters in Hai Duong, Vietnam.
- To be eligible, clusters will have a minimum of 5 participants and a maximum of 15 participants. Clusters will be defined as geographic areas serving local health stations.
Exclusion Criteria
- Significant cognitive impairment or sensory deficit.
Data sourced from ClinicalTrials.gov (NCT04542317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.