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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• VA Office of Research and Development

  collaborator FED

• University of Western Ontario, Canada

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Sherrilene Classen, PhD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2022-07-22

Completion

2023-12-20

Countries

• United States

Study Locations