Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans

Completed · Not applicable

Conditions studied: Traumatic Brain Injury (TBI), Post Traumatic Stress Disorder (PTSD)

In brief

The main objective of this study is to discern if an Occupational Therapy Driving Intervention (OT-DI) improves fitness to drive abilities of Combat Veterans and also investigate if results leads to reduced driving errors on the driving simulator and an on-road test. The driving behavior of 260 Combat Veterans will be studied on a driving simulator at baseline after which they will be randomized into control and intervention groups. The intervention group will receive sessions of Occupational Therapy Driving Intervention by a trained driving rehabilitation specialist. The control group on the other hand will receive driving safety education sessions by a driving safety professional. Both groups will be evaluated for driving performance on the driving simulator to ascertain whether there have been changes in the number of driving errors at two and three months upon enrollment. Caregiver responses on driving behavior of Combat Veteran and public driving records from The Department of Motor Vehicles will be analyzed to for changes in number of driving errors.

Key facts

Study ID

NCT02765672

Run by

University of Florida

People needed

58

Starts

2016-12-01

Expected to finish

2023-12-20

Last updated by the study team

2024-01-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Combat Veterans with polytrauma (mild traumatic brain injury (TBI)/ with accompanying post-traumatic stress disorder (PTSD), traumatic limb amputation/fractures) who drove prior to injury/condition.
• Have a valid driver's license or are eligible for a driver's license.
• Are community dwelling.
• Combat Veterans without formal diagnoses who report driving issues (either formal such as violations, citations or motor vehicle crashes, or informal including risky driving or driving stress and/or anxiety)
• Have potential for following driving safety recommendations Mini-Mental State Examination (MMSE 24/30)
• Are able to participate in a driving evaluation battery.
• Inclusion criterion for caregivers is based on their ability to complete a driving questionnaire pre and post intervention.

You may not qualify if…

• Combat Veterans who have severe psychiatric (e.g., psychoses) or physical conditions (e.g., 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, un-remediable medical conditions (e.g., severe TBI) as per the consulting physician;
• Pregnant females or those planning pregnancy as determined by self-report.
• Exclusion criterion for caregivers is based on the presence of a cognitive or physical impairment that would hinder their ability to complete the questionnaires or make an active contribution.

Where it is running

• Malcom Randall VA Medical Center — Gainesville, Florida, United States
• University of Florida, Occupational Therapy Department — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.