REACH Hope Intervention for Dementia and TBI Caregivers

TBI (Traumatic Brain Injury) Clinical Trial

— REACH Hope  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04969796
• Other study ID #: AZ190094
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: August 14, 2023

Study information

• Verified date: March 2023
• Source: Memphis VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: August 14, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Caregiver Center, VA Medical Center	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Memphis VA Medical Center	University of Tennessee, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Burden at three months	Measured by the Zarit Burden Inventory- 12	three months
Primary	Change from baseline Burden at six months	Measured by the Zarit Burden Inventory- 12	six months
Secondary	Change from baseline Depression at three months	As measured with the Patient Health Questionnaire-9	Three months
Secondary	Change from baseline Depression at six months	As measured with the Patient Health Questionnaire-9	Six months
Secondary	Change from baseline Anxiety at three months	As measured with the General Anxiety Disorders-7	Three months
Secondary	Change from baseline Anxiety at six months	As measured with the General Anxiety Disorders-7	six months
Secondary	Change from baseline Caregiving self-efficacy at three months	As measured with the Caregiving Self-Efficacy scale	three months
Secondary	Change from baseline Caregiving self-efficacy at six months	As measured with the Caregiving Self-Efficacy scale	six months