ClinicalTrials.gov
ClinicalTrials.gov Menu

Alzheimer's Family Caregiver Intervention in Vietnam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03100617
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimers Behavioral: Psychosocial caregiver intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm Study of Modified REACH-VA Alzheimer's Caregiver Intervention in Vietnam
Actual Study Start Date : August 26, 2017
Estimated Primary Completion Date : June 18, 2018
Estimated Study Completion Date : June 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.




Primary Outcome Measures :
  1. Caregiver burden [ Time Frame: Change from baseline Zarit burden scale score to 3 months. ]
    Zarit burden scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary adult family caregiver of person with dementia

Exclusion Criteria:

  • Caregivers of persons with dementia who are institutionalized

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100617


Locations
Vietnam
Vietnam National Geriatric Hospital Recruiting
Hanoi, Vietnam
Contact: Ladson Hinton, MD    916-734-3485    lwhinton@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
University of South Carolina

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03100617     History of Changes
Other Study ID Numbers: 1084736
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
Family caregiver

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases