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

Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: TBI (Traumatic Brain Injury); Dementia, Mixed; Dementia of Alzheimer Type
• Intervention / Treatment: Other: REACH Hope

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolyn Clark, MA; Phone Number: 901 577-7485; Email: vhamemreach@va.gov

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Caregiver Center, VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REACH Hope; Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.	Other: 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.
Active Comparator: Wait list control; Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Burden at three months	Measured by the Zarit Burden Inventory- 12	three months
Change from baseline Burden at six months	Measured by the Zarit Burden Inventory- 12	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Depression at three months	As measured with the Patient Health Questionnaire-9	Three months
Change from baseline Depression at six months	As measured with the Patient Health Questionnaire-9	Six months
Change from baseline Anxiety at three months	As measured with the General Anxiety Disorders-7	Three months
Change from baseline Anxiety at six months	As measured with the General Anxiety Disorders-7	six months
Change from baseline Caregiving self-efficacy at three months	As measured with the Caregiving Self-Efficacy scale	three months
Change from baseline Caregiving self-efficacy at six months	As measured with the Caregiving Self-Efficacy scale	six months

Collaborators and Investigators

• Sponsor: Memphis VA Medical Center
• Collaborators: Virginia Commonwealth University; University of Tennessee
• Investigators: Principal Investigator: Linda O Nichols, PhD, US Department of Veterans Affairs; Principal Investigator: Paul Perrin, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 14, 2023

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Tauopathies; Brain Injuries; Dementia; Brain Injuries, Traumatic; Alzheimer Disease
• Other Study ID Numbers: AZ190094

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No