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REACH Hope Intervention for Dementia and TBI Caregivers (REACH Hope)

Primary Purpose

Dementia, Mixed, Dementia of Alzheimer Type, TBI (Traumatic Brain Injury)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REACH Hope
Sponsored by
Memphis VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia, Mixed

Eligibility Criteria

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

Inclusion Criteria:

  • primary caregiver for person with diagnosis of TBI and subsequent dementia
  • at least one activity of daily living limitation or 2 or more instrumental activity of daily living limitation
  • provide 4 or more hours of care per day for at least 6 months
  • endorse a score of at least high burden (>8) on the Zarit Burden Inventory-4

Exclusion Criteria:

  • no mobile telephone or electronic device that can accept the Hope Box application
  • current diagnosis of schizophrenia or other major mental illness
  • auditory impairment that would make telephone use difficult

Sites / Locations

  • Caregiver Center, VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REACH Hope

Wait list control

Arm Description

Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.

Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.

Outcomes

Primary Outcome Measures

Change from baseline Burden at three months
Measured by the Zarit Burden Inventory- 12
Change from baseline Burden at six months
Measured by the Zarit Burden Inventory- 12

Secondary Outcome Measures

Change from baseline Depression at three months
As measured with the Patient Health Questionnaire-9
Change from baseline Depression at six months
As measured with the Patient Health Questionnaire-9
Change from baseline Anxiety at three months
As measured with the General Anxiety Disorders-7
Change from baseline Anxiety at six months
As measured with the General Anxiety Disorders-7
Change from baseline Caregiving self-efficacy at three months
As measured with the Caregiving Self-Efficacy scale
Change from baseline Caregiving self-efficacy at six months
As measured with the Caregiving Self-Efficacy scale

Full Information

First Posted
July 1, 2021
Last Updated
March 8, 2023
Sponsor
Memphis VA Medical Center
Collaborators
Virginia Commonwealth University, University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT04969796
Brief Title
REACH Hope Intervention for Dementia and TBI Caregivers
Acronym
REACH Hope
Official Title
Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memphis VA Medical Center
Collaborators
Virginia Commonwealth University, University of Tennessee

4. Oversight

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

5. Study Description

Brief Summary
This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. The study will combine and deliver two award-winning behavioral interventions - REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box, which we call REACH Hope. Both REACH and Hope Box have evidence of effectiveness individually but have not been delivered together for caregivers supporting veterans with complex neurodegenerative diagnoses and health conditions. Our primary hypothesis is that REACH Hope will improve caregivers' quality of life as measured by reduced burden.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mixed, Dementia of Alzheimer Type, TBI (Traumatic Brain Injury)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a wait list control design.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REACH Hope
Arm Type
Experimental
Arm Description
Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.
Arm Title
Wait list control
Arm Type
Active Comparator
Arm Description
Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.
Intervention Type
Other
Intervention Name(s)
REACH Hope
Intervention Description
REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box. For REACH Hope, as the caregiver and interventionist work on strategies one-on-one, these will be integrated into the Hope Box for the caregiver to use between and after sessions.
Primary Outcome Measure Information:
Title
Change from baseline Burden at three months
Description
Measured by the Zarit Burden Inventory- 12
Time Frame
three months
Title
Change from baseline Burden at six months
Description
Measured by the Zarit Burden Inventory- 12
Time Frame
six months
Secondary Outcome Measure Information:
Title
Change from baseline Depression at three months
Description
As measured with the Patient Health Questionnaire-9
Time Frame
Three months
Title
Change from baseline Depression at six months
Description
As measured with the Patient Health Questionnaire-9
Time Frame
Six months
Title
Change from baseline Anxiety at three months
Description
As measured with the General Anxiety Disorders-7
Time Frame
Three months
Title
Change from baseline Anxiety at six months
Description
As measured with the General Anxiety Disorders-7
Time Frame
six months
Title
Change from baseline Caregiving self-efficacy at three months
Description
As measured with the Caregiving Self-Efficacy scale
Time Frame
three months
Title
Change from baseline Caregiving self-efficacy at six months
Description
As measured with the Caregiving Self-Efficacy scale
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary caregiver for person with diagnosis of TBI and subsequent dementia at least one activity of daily living limitation or 2 or more instrumental activity of daily living limitation provide 4 or more hours of care per day for at least 6 months endorse a score of at least high burden (>8) on the Zarit Burden Inventory-4 Exclusion Criteria: no mobile telephone or electronic device that can accept the Hope Box application current diagnosis of schizophrenia or other major mental illness auditory impairment that would make telephone use difficult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda O Nichols, PhD
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Perrin, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caregiver Center, VA Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

REACH Hope Intervention for Dementia and TBI Caregivers

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