- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03587974
Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam
July 7, 2020 updated by: University of California, Davis
Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hanoi, Vietnam
- Vietnam National Geriatric Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Family member providing care to someone in household with Alzheimer's disease or a related dementia
Exclusion Criteria:
- Cognitively impaired
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: REACH-VN
In-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
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Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease
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No Intervention: Enhanced control
Single session with education about nature of dementia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Zarit Burden Inventory-4
Time Frame: 3 months
|
Measure of caregiver burden.
Range is 0-16.
Higher score indicates worse outcome (i.e., more burden).
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-4
Time Frame: 3 months
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Depressive and anxiety symptoms.
Range is 0-12.
Higher score indicates worse outcome (i.e., greater symptom severity).
|
3 months
|
Alzheimer's Disease Knowledge Scale
Time Frame: 3 months
|
Scale that assess knowledge of Alzheimer's disease.
Range is 0-30.
Higher score is better outcome (i.e., more accurate knowledge).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ladson Hinton, MD, UC Davis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2018
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
October 31, 2018
Study Registration Dates
First Submitted
July 3, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (Actual)
July 16, 2018
Study Record Updates
Last Update Posted (Actual)
July 22, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 1223433
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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