TBI (Traumatic Brain Injury) Clinical Trial
— REACH HopeOfficial title:
Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention
Verified date | March 2023 |
Source | Memphis VA Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Caregiver Center, VA Medical Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Memphis VA Medical Center | University of Tennessee, Virginia Commonwealth University |
United States,
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 |
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