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

Status

Completed

Conditions

Intervention / Treatment

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

  • Vietnam
      • Hanoi, Vietnam
        • Vietnam National Geriatric Hospital

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
Behavioral: REACH-VIETNAM
Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease
No Intervention: Enhanced control
Single session with education about nature of dementia

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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-4
Time Frame: 3 months
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

University of California, Davis

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.

General Publications

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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