Clinical trial NCT04969796: REACH Hope Intervention for Dementia and TBI Caregivers
Official title: Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia, Mixed
Dementia of Alzheimer Type
TBI (Traumatic Brain Injury)
Lead sponsor: Memphis VA Medical Center
Sponsor class: FED
Collaborators: name: Virginia Commonwealth University
name: University of Tennessee
First posted: 2021-07-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a wait list control design.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline Burden at three months
timeFrame: three months
measure: Change from baseline Burden at six months
timeFrame: six months
Secondary outcomes:
measure: Change from baseline Depression at three months
timeFrame: Three months
measure: Change from baseline Depression at six months
timeFrame: Six months
measure: Change from baseline Anxiety at three months
timeFrame: Three months
measure: Change from baseline Anxiety at six months
timeFrame: six months
measure: Change from baseline Caregiving self-efficacy at three months
timeFrame: three months
measure: Change from baseline Caregiving self-efficacy at six months
timeFrame: six months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Caregiver Center, VA Medical Center
state: Tennessee
Study officials:
affiliation: US Department of Veterans Affairs
name: Linda O Nichols, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Paul Perrin, PhD
role: PRINCIPAL_INVESTIGATOR
References: