NCT03100617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

August 26, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

March 24, 2017

Results QC Date

February 18, 2020

Last Update Submit

August 20, 2020

Conditions

Dementia Alzheimers

Keywords

Family caregiver

Outcome Measures

Primary Outcomes (1)

  • Caregiver Burden

    Zarit Burden scale

    Change from baseline Zarit burden scale score to 3 months.

Study Arms (1)

REACH-VA family caregiver intervention

EXPERIMENTAL

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

Interventions

Psychosocial caregiver interventionBEHAVIORAL

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.

REACH-VA family caregiver intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary adult family caregiver of person with dementia

You may not qualify if:

  • Caregivers of persons with dementia who are institutionalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnam National Geriatric Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Limitations and Caveats

This was a small case series to examine acceptability and feasibility of the intervention and no outcome data were collected from the 6 participants.

Results Point of Contact

Title
Dr. Ladson Hinton
Organization
UCaliforniaDavis
lwhinton@ucdavis.edu
9167343485

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 4, 2017

Study Start

August 26, 2017

Primary Completion

June 18, 2018

Study Completion

June 18, 2018

Last Updated

September 2, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)