REACH Hope Intervention for Dementia and TBI Caregivers

Not Applicable

Active, not recruiting

• Conditions: Dementia, Mixed; TBI (Traumatic Brain Injury); Dementia of Alzheimer Type
• Interventions: Other: REACH Hope

• Registration Number: NCT04969796
• Lead Sponsor: Memphis VA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REACH Hope	REACH Hope	Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.
Wait list control	REACH Hope	Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Caregiver Center, VA Medical Center; 🇺🇸 Memphis, Tennessee, United States