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

Traumatic Brain Injury (TBI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765672
• Other study ID #: IRB201500871
• Secondary ID: JW 140063
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 20, 2023

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 20, 2023
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury (TBI)

Intervention

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)
• Community Integration Questionnaire
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
• Satisfaction with Life
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1
• 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.
• 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
• 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.
• 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
• Driving triggers evaluation
The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	University of Florida, Occupational Therapy Department	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	United States Department of Defense, University of Western Ontario, Canada, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simulator driving errors changes within the experimental and control groups at baseline, months 2 and 5	Simulator driving errors will be quantified at baseline and at month 2 and 5 for the experimental and control groups.	Changes in baseline at months 2 and 5
Secondary	On-road driving errors changes within the experimental and control groups at baseline and month 5	Driving errors will be calculated during an on-road test at baseline and at month 5, for the experimental and control groups.	Changes in baseline at months 5