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NCT03587974 Clinical Trial

Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam

Family Caregivers Clinical Trial

Official title:
Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03587974
Other study ID # 1223433
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2018
Est. completion date October 31, 2018

Study information
Verified date July 2020
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a cluster randomized controlled trial to determine the feasibility and preliminary effectiveness of culturally adapted psychosocial intervention for Alzheimer's family caregivers in Vietnam. The psychosocial intervention is being compared with an enhance control condition.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Family member providing care to someone in household with Alzheimer's disease or a related dementia

Exclusion Criteria:

- Cognitively impaired

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• REACH-VIETNAM
Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease

Locations
Country Name City State
Vietnam Vietnam National Geriatric Hospital Hanoi

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary Zarit Burden Inventory-4 Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden). 3 months
Secondary Patient Health Questionnaire-4 Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity). 3 months
Secondary Alzheimer's Disease Knowledge Scale Scale that assess knowledge of Alzheimer's disease. Range is 0-30. Higher score is better outcome (i.e., more accurate knowledge). 3 months
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