Traumatic Brain Injury (TBI) Clinical Trial
Official title:
Efficacy of a Driving Program on Safe Community Mobility for Combat Veterans
Verified date | December 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Driving is a portal into general life functioning, and impaired driving skill can pose a serious threat to the combat veterans (CV), passengers and others; and involves increased risk of subsequent injuries, medical expenses and legal sequelae. Motor vehicle crashes (MVC) among post deployed CV are one of the top four causes of injury and disability, hospitalization, and outpatient visits across the military, and are a leading cause of death among Army service members. The risk of motor vehicle (MV) death is significantly increased in years immediately following return from the battlefield. In sum, the effects of Traumatic Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and other blast related injuries, combined with the "battlefield" mindset and lack of community reintegration programs place CV at risk for MVC and fatalities. On-road assessments, the gold standard, presents a risk for crash or adverse advents in this population of CV. Alternately, simulated driving evaluation measures driving performance in a safe, accurate and objective manner with evidence of absolute and relative validity when compared to real world (on-road) driving. Knowing participants can or cannot safely resume driving, and providing rehabilitation for those with a potential for resuming safe driving could result in: increased safe driving behaviors; avoidance of injuries, collisions, citations and participants residua; and resuming safe driving with its attendant benefits in the realms of family functioning, participation in society and satisfaction with life. The overarching objective of this proposal is to discern, after clinical and simulated driving performance testing , if Occupational Therapy Driving Intervention (OT-DI) can improve the safe driving performance (less errors) over the short term (immediately following intervention) and intermediate term (3 months).
Status | Completed |
Enrollment | 66 |
Est. completion date | November 2018 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - A combat veteran with polytrauma (mild traumatic brain injury/with an accompanying post traumatic stress disorder (PTSD), traumatic limb amputation/ fractures), who drove prior to the injury/condition; - have a valid driver's license or are eligible for a driver's license; - are community dwelling; - may experience self, physician or other clinical staff identified issues with driving behaviors; - have a history of citations, violations or other driving mishaps in real world driving; - have potential for following driving safety recommendations (Mini Mental State Examination, (MMSE 24/30); - have potential for following community integration strategies (MMSE 24/30); - are able to participate in driving evaluation battery. Exclusion Criteria: - A combat veteran diagnosed with a severe psychiatric (psychoses) or physical conditions (missing both arms and/or legs) that will limit ability to drive; - have multiple psychotropic medications that may impact mental or physical (due to side-effects) functioning as per the consulting physician; - have severe, irremediable medical conditions (severe TBI) as per the consulting physician; - pregnant females (as determined by a urine test) or those planning pregnancy; - VA Employees; and - veterans who have received rehabilitation services for TBI/PTSD and who show, as per the screening of the driving rehabilitation specialist, a poor prognosis for improvement based on a driving intervention. Inclusion Criteria for Caregivers: - ability to complete a driving questionnaire pre and post intervention. Exclusion Criteria for Caregivers: - the presence of a cognitive or physical impairment that would hinder participants ability to complete the questionnaires or make an active contribution. |
Country | Name | City | State |
---|---|---|---|
United States | Malcom Randall VA Medical Center | Gainesville | Florida |
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | United States Department of Defense, University of Western Ontario, Canada, US Department of Veterans Affairs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Driving errors changes between the groups at baseline, months 2 and 3 | Determine if the Occupational Therapy Driving Intervention (OT-DI) reduces driving errors in the intervention group. | Changes in baseline months 2 and 3 | |
Secondary | Perceptions of Combat Veterans regarding driving performance | Semi-structured interview questions will be used to guide the focus group discussions. The results will be outlined in an intervention matrix which will be used to address specific driving errors and the behavior underlying those errors in the intervention process. | Occurs approximately 2 months after baseline (75 minutes) | |
Secondary | Change in driving records from baseline and at 11months | Driving records from the Department of Motor Vehicle will be collected to determine if driving errors have reduced. | From baseline (approximately 11months) |
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