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Clinical Trials/NCT04969796
NCT04969796
Active, Not Recruiting
N/A

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

Memphis VA Medical Center1 site in 1 country110 target enrollmentFebruary 2, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dementia, Mixed
Sponsor
Memphis VA Medical Center
Enrollment
110
Locations
1
Primary Endpoint
Change from baseline Burden at three months
Status
Active, Not Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2021
End Date
August 14, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change from baseline Burden at three months

Time Frame: three months

Measured by the Zarit Burden Inventory- 12

Change from baseline Burden at six months

Time Frame: six months

Measured by the Zarit Burden Inventory- 12

Secondary Outcomes

  • Change from baseline Anxiety at three months(Three months)
  • Change from baseline Caregiving self-efficacy at three months(three months)
  • Change from baseline Depression at three months(Three months)
  • Change from baseline Depression at six months(Six months)
  • Change from baseline Anxiety at six months(six months)
  • Change from baseline Caregiving self-efficacy at six months(six months)

Study Sites (1)

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