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Alzheimer's Family Caregiver Intervention in Vietnam

Primary Purpose

Dementia Alzheimers

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Psychosocial caregiver intervention
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia Alzheimers focused on measuring Family caregiver

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary adult family caregiver of person with dementia

Exclusion Criteria:

  • Caregivers of persons with dementia who are institutionalized

Sites / Locations

  • Vietnam National Geriatric Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REACH-VA family caregiver intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Caregiver Burden
Zarit Burden scale

Secondary Outcome Measures

Full Information

First Posted
March 24, 2017
Last Updated
August 20, 2020
Sponsor
University of California, Davis
Collaborators
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03100617
Brief Title
Alzheimer's Family Caregiver Intervention in Vietnam
Official Title
Single Arm Study of Modified REACH-VA Alzheimer's Caregiver Intervention in Vietnam
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2017 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
June 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimers
Keywords
Family caregiver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REACH-VA family caregiver intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial caregiver intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caregiver Burden
Description
Zarit Burden scale
Time Frame
Change from baseline Zarit burden scale score to 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary adult family caregiver of person with dementia Exclusion Criteria: Caregivers of persons with dementia who are institutionalized
Facility Information:
Facility Name
Vietnam National Geriatric Hospital
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alzheimer's Family Caregiver Intervention in Vietnam

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