Traumatic Brain Injury Clinical Trial
— REACH TBIOfficial title:
The REACH Intervention for Caregivers of Veterans and Service Members With TBI: Efficacy and Implementation Planning Across the VA Polytrauma System of Care
This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | August 2026 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: To be eligible for the study, the participant must: - identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior; - identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months; - provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI; - believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and - endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4. Exclusion Criteria: - no telephone; - current diagnosis of schizophrenia or other major mental illness; - auditory impairment that would make telephone use difficult; or - the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI. |
Country | Name | City | State |
---|---|---|---|
United States | Tampa VA Medical Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | James A. Haley Veterans Administration Hospital, University of Tennessee, University of Utah, Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TBI-CareQOL Caregiver Strain - Short Form 6a | It assesses caregiver strain in caregivers of individuals with TBI. Values range from 6-30, with higher scores indicating greater strain/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | |
Secondary | Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a | It assesses caregiver depression. Values range from 8-40, with higher scores indicating greater depression/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | |
Secondary | Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a | It assesses caregiver anxiety. Values range from 7-35, with higher scores indicating greater anxiety/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | |
Secondary | Patient-Reported Outcomes Measurement Information System - General Self-Efficacy | It assesses caregiver self-efficacy. Values from range 10-50, with higher scores indicating greater self-efficacy/better outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | |
Secondary | TBI-CareQOL Health Care Frustration - Self - Short Form 6a | It assesses frustrations a TBI caregiver has had with health care services. Values range from 6-30, with higher scores indicating greater frustration with services received/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Terminated |
NCT03698747 -
Myelin Imaging in Concussed High School Football Players
|
||
Recruiting |
NCT05130658 -
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
|
N/A | |
Recruiting |
NCT04560946 -
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
|
N/A | |
Completed |
NCT05160194 -
Gaining Real-Life Skills Over the Web
|
N/A | |
Recruiting |
NCT02059941 -
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
|
N/A | |
Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
Completed |
NCT04465019 -
Exoskeleton Rehabilitation on TBI
|
||
Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
Suspended |
NCT04244058 -
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
|
Early Phase 1 | |
Completed |
NCT03307070 -
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
|
N/A | |
Recruiting |
NCT04274777 -
The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
|
||
Withdrawn |
NCT04199130 -
Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
|
N/A | |
Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 |