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Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam

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ClinicalTrials.gov Identifier: NCT03587974
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Family Caregivers Behavioral: REACH-VIETNAM Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam
Actual Study Start Date : June 10, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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



Primary Outcome Measures :
  1. Caregiving burden [ Time Frame: 3 months ]
    Zarit Burden Inventory (4 items)


Secondary Outcome Measures :
  1. Depressive symptoms [ Time Frame: 3 months ]
    PHQ-4

  2. Alzheimer's disease knowledge [ Time Frame: 3 months ]
    AD knowledge scale



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Family member providing care to someone in household with Alzheimer's disease or a related dementia

Exclusion Criteria:

  • Cognitively impaired

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): NCT03587974


Contacts
Contact: Ladson Hinton, MD 916-734-3485 lwhinton@ucdavis.edu

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
Investigators
Principal Investigator: Ladson Hinton, MD UC Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03587974     History of Changes
Other Study ID Numbers: 1190832
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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