Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam
Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2018
CompletedFirst Submitted
Initial submission to the registry
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedResults Posted
Study results publicly available
July 22, 2020
CompletedJuly 22, 2020
July 1, 2020
5 months
July 3, 2018
April 21, 2020
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Zarit Burden Inventory-4
Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden).
3 months
Secondary Outcomes (2)
Patient Health Questionnaire-4
3 months
Alzheimer's Disease Knowledge Scale
3 months
Study Arms (2)
REACH-VN
EXPERIMENTALIn-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months
Enhanced control
NO INTERVENTIONSingle session with education about nature of dementia
Interventions
Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease
Eligibility Criteria
You may qualify if:
- Family member providing care to someone in household with Alzheimer's disease or a related dementia
You may not qualify if:
- Cognitively impaired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vietnam National Geriatric Hospital
Hanoi, Vietnam
Related Publications (1)
Nguyen TA, Nguyen H, Pham T, Nguyen TH, Hinton L. A cluster randomized controlled trial to test the feasibility and preliminary effectiveness of a family dementia caregiver intervention in Vietnam: The REACH VN study protocol. Medicine (Baltimore). 2018 Oct;97(42):e12553. doi: 10.1097/MD.0000000000012553.
PMID: 30334942DERIVED
Results Point of Contact
- Title
- Dr. Ladson Hinton
- Organization
- UCaliforniaDavis
Study Officials
- PRINCIPAL INVESTIGATOR
Ladson Hinton, MD
UC Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2018
First Posted
July 16, 2018
Study Start
June 10, 2018
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
July 22, 2020
Results First Posted
July 22, 2020
Record last verified: 2020-07