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

NCT ID: NCT03587974

Last Updated: 2020-07-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-10

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Family Caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

REACH-VIETNAM

Intervention Type BEHAVIORAL

Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease

Enhanced control

Single session with education about nature of dementia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REACH-VIETNAM

Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cognitively impaired
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ladson Hinton, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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Vietnam National Geriatric Hospital

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

References

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Nguyen TA, Nguyen H, Pham T, Nguyen TH, Hinton L. A cluster randomized controlled trial to test the feasibility and preliminary effectiveness of a family dementia caregiver intervention in Vietnam: The REACH VN study protocol. Medicine (Baltimore). 2018 Oct;97(42):e12553. doi: 10.1097/MD.0000000000012553.

Reference Type DERIVED
PMID: 30334942 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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1223433

Identifier Type: -

Identifier Source: org_study_id

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