REACH Hope Intervention for Dementia and TBI Caregivers

NCT ID: NCT04969796

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2023-08-14

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a wait list control design.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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REACH Hope

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

Group Type EXPERIMENTAL

REACH Hope

Intervention Type OTHER

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.

Wait list control

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

Group Type ACTIVE_COMPARATOR

REACH Hope

Intervention Type OTHER

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.

Interventions

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REACH Hope

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role collaborator

Memphis VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda O Nichols, PhD

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Paul Perrin, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Caregiver Center, VA Medical Center

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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Nichols LO, Martindale-Adams J, Seel RT, Zuber JK, Perera R, Perrin PB. Reducing burden and anxiety for caregivers of veterans with traumatic brain injury and dementia: Randomized controlled trial of the resources for enhancing all caregivers' health-Hope intervention. Rehabil Psychol. 2025 Jul 31:10.1037/rep0000632. doi: 10.1037/rep0000632. Online ahead of print.

Reference Type DERIVED
PMID: 40742769 (View on PubMed)

Other Identifiers

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AZ190094

Identifier Type: -

Identifier Source: org_study_id

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