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

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Driving Behavior Interview
Clinical Driving Assessment
Propensity for Angry Driving Scale
Community Integration Questionnaire
Satisfaction with Life
Fitness-to-Drive Screening Measure (FTDS)
Simulated Driving Evaluation
Driving Safety Education
Occupational Therapy Driving Intervention (OT-DI)
On-road driving test
Driving triggers evaluation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury (TBI) focused on measuring Combat Veterans, Automobile Driving, Fitness to Drive

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Malcom Randall VA Medical Center
  • University of Florida, Occupational Therapy Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control Group

Experimental Group

Caregiver Control Group

Caregiver Experimental Group

On-road driving Group

Simulator-drives Evaluation Group

Arm Description

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.

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.

Caregiver control group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 5, 2016
Last Updated
October 24, 2022
Sponsor
University of Florida
Collaborators
United States Department of Defense, VA Office of Research and Development, University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02765672
Brief Title
Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
Official Title
Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 22, 2022 (Actual)
Study Completion Date
July 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
United States Department of Defense, VA Office of Research and Development, University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury (TBI), Post Traumatic Stress Disorder (PTSD)
Keywords
Combat Veterans, Automobile Driving, Fitness to Drive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Caregiver Control Group
Arm Type
Active Comparator
Arm Description
Caregiver control group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.
Arm Title
Caregiver Experimental Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
On-road driving Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Simulator-drives Evaluation Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Driving Behavior Interview
Intervention Description
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
Intervention Type
Other
Intervention Name(s)
Clinical Driving Assessment
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Propensity for Angry Driving Scale
Intervention Description
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
Intervention Type
Behavioral
Intervention Name(s)
Community Integration Questionnaire
Intervention Description
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
Intervention Type
Behavioral
Intervention Name(s)
Satisfaction with Life
Intervention Description
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1
Intervention Type
Behavioral
Intervention Name(s)
Fitness-to-Drive Screening Measure (FTDS)
Intervention Description
Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study
Intervention Type
Procedure
Intervention Name(s)
Simulated Driving Evaluation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Driving Safety Education
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Occupational Therapy Driving Intervention (OT-DI)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
On-road driving test
Intervention Description
This involves and on-road driving test supervised by Driving Rehabilitation Specialist. To be completed at baseline and at month 5
Intervention Type
Procedure
Intervention Name(s)
Driving triggers evaluation
Intervention Description
The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing
Primary Outcome Measure Information:
Title
Simulator driving errors changes within the experimental and control groups at baseline, months 2 and 5
Description
Simulator driving errors will be quantified at baseline and at month 2 and 5 for the experimental and control groups.
Time Frame
Changes in baseline at months 2 and 5
Secondary Outcome Measure Information:
Title
On-road driving errors changes within the experimental and control groups at baseline and month 5
Description
Driving errors will be calculated during an on-road test at baseline and at month 5, for the experimental and control groups.
Time Frame
Changes in baseline at months 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherrilene Classen, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida, Occupational Therapy Department
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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