NCT02765672

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This research study is being done to determine if Occupational Therapy Driving intervention (OT-DI) can improve the safe driving performance immediately following intervention and intermediate term (3months). Baseline testing to post test1 will include Clinical battery of tests and a Simulated Driving test, a Brief Driving Questionnaire, Community Integration Questionnaire, and Satisfaction with Life Questionnaire. Caregivers/family member will rate the participants' driving behaviors using a Fitness-to-Drive Screening Measure (FTDS). After baseline testing the 260 participants (and associated caregivers) will be randomly assigned to balanced intervention and control groups. The intervention group receives Occupational Therapy Driving Intervention (OT-DI) consisting of three x 1hour sessions will include Sessions1: Driving evaluator reviews explicit driving errors with participants; Session 2: Driving evaluator provides tailored strategies to mitigate errors; Session 3: Participants drive simulator with targeted feedback from driving evaluator. The control group will receive from a driving safety professional, three x 1 hour general safety sessions (session 1: general traffic safety discussion; Session 2: Rules of the road and acknowledgement of the road discussion; Session 3: drive the simulator without any feedback from a driving safety professional). Immediately after session 3, Post test1 will occur using the same standardized protocol outline for baseline testing. Post test2: will consist of testing with the same standardized protocol as administered during baseline testing. Caregivers/family members will rate the participants driving behavior using FTDS in addition the investigators will obtain driving data from the Department of Motor Vehicles which include citations, violations, driving mishaps that have occurred for each participant. To ascertain impact of the OT-DI and driving safety education on real world driving, a subset of 30 participants will be created from the control and intervention groups to perform on-road driving test. The results from this test will be compared with driving performance on the simulated drives.

Conditions

• Traumatic Brain Injury (TBI)
• Post Traumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
BEHAVIORAL	Driving Behavior Interview	This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
OTHER	Clinical Driving Assessment	Clinical Driving Assessment includes Optec vision screening, Useful Field of View, Range of Motion, Mini-Mental State Examination (MMSE) and Strength tests. This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
BEHAVIORAL	Propensity for Angry Driving Scale	This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
BEHAVIORAL	Community Integration Questionnaire	This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
BEHAVIORAL	Satisfaction with Life	This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1
BEHAVIORAL	Fitness-to-Drive Screening Measure (FTDS)	Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study
PROCEDURE	Simulated Driving Evaluation	This involves driving a simulator fitted simulated drives engineered to to address Veteran's driving concerns such as reactions to other drivers and road conditions(e.g. debris). The simulator is used at baseline and at post-test1 and 2. The intervention and traffic safety education session 3 also occurs using the driving simulator.
PROCEDURE	Driving Safety Education	This involves the following: Session1: general traffic safety discussion; Session 2: Rules of the road and acknowledgement of the road discussion and Session 3: driving the simulator without any feedback from traffic safety professional
PROCEDURE	Occupational Therapy Driving Intervention (OT-DI)	This has three sessions: 1. Driving evaluator reviews explicit driving errors with Combat Veteran; 2. driving evaluator provide tailored strategies to mitigate errors; Combat Veteran drives simulator with targeted feedback from driving evaluator.
PROCEDURE	On-road driving test	This involves and on-road driving test supervised by Driving Rehabilitation Specialist. To be completed at baseline and at month 5
PROCEDURE	Driving triggers evaluation	The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-07-22
• Completion: 2023-12-20
• First posted: 2016-05-06
• Last updated: 2024-01-19

Locations

2 sites across 1 country: United States