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

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ClinicalTrials.gov Identifier: NCT02765672
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : July 27, 2018
Sponsor:
Collaborators:
United States Department of Defense
VA Office of Research and Development
University of Western Ontario, Canada
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury (TBI) Post Traumatic Stress Disorder (PTSD) Behavioral: Driving Behavior Interview Other: Clinical Driving Assessment Behavioral: Propensity for Angry Driving Scale Behavioral: Community Integration Questionnaire Behavioral: Satisfaction with Life Behavioral: Fitness-to-Drive Screening Measure (FTDS) Procedure: Simulated Driving Evaluation Procedure: Driving Safety Education Procedure: Occupational Therapy Driving Intervention (OT-DI) Procedure: On-road driving test Procedure: Driving triggers evaluation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
Study Start Date : December 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Active Comparator: Control Group
Participants 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.
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

Experimental: Experimental Group
Participants 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.
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: 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.

Active Comparator: Caregiver Control Group
Caregiver control group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.
Behavioral: Fitness-to-Drive Screening Measure (FTDS)
Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study

Active Comparator: Caregiver Experimental Group
Caregivers of the experimental group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.
Behavioral: Fitness-to-Drive Screening Measure (FTDS)
Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study

Active Comparator: On-road driving Group
A 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
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

Active Comparator: Simulator-drives Evaluation Group
This 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
Procedure: Driving triggers evaluation
The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing




Primary Outcome Measures :
  1. Simulator driving errors changes within the experimental and control groups at baseline, months 2 and 5 [ Time Frame: Changes in baseline at months 2 and 5 ]
    Simulator driving errors will be quantified at baseline and at month 2 and 5 for the experimental and control groups.


Secondary Outcome Measures :
  1. On-road driving errors changes within the experimental and control groups at baseline and month 5 [ Time Frame: Changes in baseline at months 5 ]
    Driving errors will be calculated during an on-road test at baseline and at month 5, for the experimental and control groups.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765672


Contacts
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Contact: Sherrilene Classen, PhD (352) 273-6883 sclassen@phhp.ufl.edu
Contact: Abraham Yarney, MS (352) 273-6043 ayarney@phhp.ufl.edu

Locations
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United States, Florida
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Myers Keith, MD    352-376-1611    Keith.Myers2@va.gov   
Contact: Bruce Mueller    (352) 379-4129    bruce.mueller@va.gov   
Sub-Investigator: Charles Levy, MD         
Sub-Investigator: David Fitzgerld, MD         
University of Florida, Occupational Therapy Department Recruiting
Gainesville, Florida, United States, 32610
Contact: William Mann, PhD    352-273-6817    wmann@phhp.ufl.edu   
Contact: Rebecca Harty    (352) 273-6817    rharty@phhp.ufl.edu   
Sub-Investigator: Babette Brumback, PhD         
Sub-Investigator: Michael Marsiske, PhD         
Principal Investigator: Sherrilene Classen, PhD         
Sponsors and Collaborators
University of Florida
United States Department of Defense
VA Office of Research and Development
University of Western Ontario, Canada
Investigators
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Principal Investigator: Sherrilene Classen, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02765672     History of Changes
Other Study ID Numbers: IRB201500871
JW 140063 ( Other Grant/Funding Number: US Army Med Res and Material Com )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Florida:
Combat Veterans
Automobile Driving
Fitness to Drive

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders