Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04969796
Other study ID # AZ190094
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04526639 - VR Cognitive Rehabiliation for Pediatric TBI N/A
Recruiting NCT05943756 - Evaluation of Well-being Interventions in Adults With TBI N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Completed NCT00760734 - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Phase 1
Not yet recruiting NCT06024122 - Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Completed NCT03896789 - Pediatric Guideline Adherence and Outcomes- Argentina N/A
Completed NCT03225768 - Guided Training for People With Cognitive Impairment N/A
Completed NCT04590911 - Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood N/A
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT04776304 - Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms N/A
Completed NCT00409058 - Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI N/A
Completed NCT00205491 - Pharmacological Intervention in Depression After Traumatic Brain Injury Phase 4
Completed NCT03490110 - Brain Markers of Improvements in Cognitive Functioning N/A
Active, not recruiting NCT02525432 - Autologous Stem Cell Study for Adult TBI (Phase 2b) Phase 2
Completed NCT02858544 - Concussion in Motor Vehicle Accidents: The Concussion Identification Index N/A
Completed NCT01728831 - Study of Cerebral Tissue Oxygenation During Transfusion in Traumatic Brain Injury N/A
Recruiting NCT06005194 - InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI N/A
Not yet recruiting NCT05340803 - Sedation of Ventilated Traumatic Brain Injury Patients With Midazolam Alone Versus Combination With Dexmedetomidine or Magnesium Sulfate; Monitored by Ultrasonograghic Optic Nerve Sheath Diameter Phase 3
Recruiting NCT06195345 - Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Recruiting NCT04279431 - Follow-up of mTBI Patients Discharged From the ED Using Standard Clinical Triage Including BrainScope One