Alzheimer's Family Caregiver Intervention in Vietnam

August 20, 2020 updated by: University of California, Davis

Single Arm Study of Modified REACH-VA Alzheimer's Caregiver Intervention in Vietnam

This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a Alzheimer's family caregiver intervention in Vietnam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a modified version of the REACH-VA caregiver intervention in Vietnam. The REACH-VA caregiver intervention is an evidence-based intervention that has been shown to be effective in multicultural populations in the US. The model has been modified for use in Vietnam. This study will test the modified model in Vietnam. Participants in this study will be adult family caregivers of non-institutionalized persons with dementia who are living in Hanoi, Vietnam. They will receive 4-6 sessions delivered over the course of 2-3 months that will included the following components: 1) education about the nature of the disease, 2) risk assessment, 3) enhancing caregiver skills and problem-solving, and 4) caregiver stress reduction. The intervention will be delivered by a social worker or nurse using a Vietnamese language versions of the REACH-VA protocol and caregiver intervention notebook.

Study Type

Interventional

Enrollment (Actual)

6

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary adult family caregiver of person with dementia

Exclusion Criteria:

  • Caregivers of persons with dementia who are institutionalized

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REACH-VA family caregiver intervention
Behavioral intervention with several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction.
Behavioral: Psychosocial caregiver intervention
Modified version of the REACH-VA intervention for family caregivers of persons with dementia. The intervention has several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Burden
Time Frame: Change from baseline Zarit burden scale score to 3 months.
Zarit Burden scale
Change from baseline Zarit burden scale score to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

University of South Carolina

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)

August 26, 2017

Primary Completion (Actual)

June 18, 2018

Study Completion (Actual)

June 18, 2018

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1084736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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