Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
2 other identifiers
interventional
58
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedJanuary 19, 2024
January 1, 2024
5.6 years
May 5, 2016
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
On-road driving errors changes within the experimental and control groups at baseline and month 5
Changes in baseline at months 5
Study Arms (6)
Control Group
ACTIVE COMPARATORParticipants in this group will have the following performed: Institute of Mobility Activity and Participation's clinical battery tests and a simulated driving evaluation, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, Fitness-to-Drive Screening Measure (FTDS), and a Satisfaction with Life Questionnaire. Driving Safety Education by a traffic safety professional, three x 1 hour sessions to discuss traffic safety rules regarding person, vehicle, environmental factors.
Experimental Group
EXPERIMENTALParticipants in this group will have the following performed: Institute of Mobility Activity and Participation's clinical battery tests and a simulated driving tests, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, Fitness-to-Drive Screening Measure(FTDS), and a Satisfaction with Life Questionnaire. Occupational Therapy Driving Intervention (OT-DI) consisting of three x 1 hour sessions to review explicit driving errors, strategies to mitigate errors and receiving feedback from the evaluator after driving the simulator.
Caregiver Control Group
ACTIVE COMPARATORCaregiver control group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.
Caregiver Experimental Group
ACTIVE COMPARATORCaregivers of the experimental group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.
On-road driving Group
ACTIVE COMPARATORA subset of 30 Combat Veterans will be drawn from the control group (15 no.) and experimental group (15 no.). This group of Combat Veterans will will undergo an on-road driving test at baseline and month 5
Simulator-drives Evaluation Group
ACTIVE COMPARATORThis group will comprise of 30 Combat Veterans who will be drawn outside of the randomized experimental and and control groups participants. This group will only perform simulator driving triggers evaluation
Interventions
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
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)
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1
Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study
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.
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
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.
This involves and on-road driving test supervised by Driving Rehabilitation Specialist. To be completed at baseline and at month 5
The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- United States Department of Defensecollaborator
- VA Office of Research and Developmentcollaborator
- University of Western Ontario, Canadacollaborator
Study Sites (2)
Malcom Randall VA Medical Center
Gainesville, Florida, 32608, United States
University of Florida, Occupational Therapy Department
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sherrilene Classen, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 6, 2016
Study Start
December 1, 2016
Primary Completion
July 22, 2022
Study Completion
December 20, 2023
Last Updated
January 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share