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Occupational Therapy Driving Intervention for Returning Combat Veterans.

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Driving Behavior Interview
Fitness-to-Drive Screening Measure
Clinical Driving Assessment
Propensity for Angry Driving Scale
Community Integration Questionnaire
Satisfaction with Life Questionnaire
Driving simulator evaluation
Focus Group Discussion Interview Guide
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:

  • A combat veteran with polytrauma (mild traumatic brain injury/with an accompanying post traumatic stress disorder (PTSD), traumatic limb amputation/ fractures), who drove prior to the injury/condition;
  • have a valid driver's license or are eligible for a driver's license;
  • are community dwelling;
  • may experience self, physician or other clinical staff identified issues with driving behaviors;
  • have a history of citations, violations or other driving mishaps in real world driving;
  • have potential for following driving safety recommendations (Mini Mental State Examination, (MMSE 24/30);
  • have potential for following community integration strategies (MMSE 24/30);
  • are able to participate in driving evaluation battery.

Exclusion Criteria:

  • A combat veteran diagnosed with a severe psychiatric (psychoses) or physical conditions (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, irremediable medical conditions (severe TBI) as per the consulting physician;
  • pregnant females (as determined by a urine test) or those planning pregnancy;
  • VA Employees; and
  • veterans who have received rehabilitation services for TBI/PTSD and who show, as per the screening of the driving rehabilitation specialist, a poor prognosis for improvement based on a driving intervention.

Inclusion Criteria for Caregivers:

  • ability to complete a driving questionnaire pre and post intervention.

Exclusion Criteria for Caregivers:

  • the presence of a cognitive or physical impairment that would hinder participants ability to complete the questionnaires or make an active contribution.

Sites / Locations

  • Malcom Randall VA Medical Center
  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Active Comparator

Active Comparator

Other

Arm Label

Control Group

Experimental Group

Caregiver Control Group

Caregiver Experimental Group

Focus Group Discussion Interview Guide

Arm Description

Participants in this group will have the following performed: Institute of Mobility Activity and Participation (I-MAP's) clinical battery of tests and a simulated driving test, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, and a Satisfaction with Life Questionnaire. Driving safety professional, three x 1 hour sessions to discuss traffic safety, rules of the road, defensive driving, driving under influence, driver attitudes and safety. Additionally, the study will obtain real world driving data from the Department of Motor Vehicles (public records) which will include citations, violations, and recorded collisions/ crashes.

Participants in this group will have the following performed: Institute of Mobility Activity and Participation (I-MAP's) clinical battery of tests and a simulated driving test, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, 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 driving simulator with feedback. The study will also obtain real world driving data from the Department of Motor Vehicles (public records) which includes citations, violations, and recorded collisions/crashes.

Participants in this group will perform the following: Fitness-to-Drive Screening Measure(FTDS) will be filled out at baseline and again at the end of the study.

Participants in this group will perform the following: Fitness-to-Drive Screening Measure(FTDS) will be filled out at baseline and again at the end of the study.

This group will comprise of a subset of the control and experimental groups. A focus group with 8 participants (4 with Traumatic Brain Injury/Post Traumatic Stress Disorder and 4 with orthopedic conditions). The focus group will meet once for a discussion which will be guided with a semi-structured interview that will explore the driving behavior prior to war, during war and post-deployment. Responses will be outlined in an intervention matrix.

Outcomes

Primary Outcome Measures

Driving errors changes between the groups at baseline, months 2 and 3
Determine if the Occupational Therapy Driving Intervention (OT-DI) reduces driving errors in the intervention group.

Secondary Outcome Measures

Perceptions of Combat Veterans regarding driving performance
Semi-structured interview questions will be used to guide the focus group discussions. The results will be outlined in an intervention matrix which will be used to address specific driving errors and the behavior underlying those errors in the intervention process.
Change in driving records from baseline and at 11months
Driving records from the Department of Motor Vehicle will be collected to determine if driving errors have reduced.

Full Information

First Posted
April 18, 2016
Last Updated
December 14, 2018
Sponsor
University of Florida
Collaborators
United States Department of Defense, US Department of Veterans Affairs, University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02764983
Brief Title
Occupational Therapy Driving Intervention for Returning Combat Veterans.
Official Title
Efficacy of a Driving Program on Safe Community Mobility for Combat Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
United States Department of Defense, US Department of Veterans Affairs, University of Western Ontario, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Driving is a portal into general life functioning, and impaired driving skill can pose a serious threat to the combat veterans (CV), passengers and others; and involves increased risk of subsequent injuries, medical expenses and legal sequelae. Motor vehicle crashes (MVC) among post deployed CV are one of the top four causes of injury and disability, hospitalization, and outpatient visits across the military, and are a leading cause of death among Army service members. The risk of motor vehicle (MV) death is significantly increased in years immediately following return from the battlefield. In sum, the effects of Traumatic Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and other blast related injuries, combined with the "battlefield" mindset and lack of community reintegration programs place CV at risk for MVC and fatalities. On-road assessments, the gold standard, presents a risk for crash or adverse advents in this population of CV. Alternately, simulated driving evaluation measures driving performance in a safe, accurate and objective manner with evidence of absolute and relative validity when compared to real world (on-road) driving. Knowing participants can or cannot safely resume driving, and providing rehabilitation for those with a potential for resuming safe driving could result in: increased safe driving behaviors; avoidance of injuries, collisions, citations and participants residua; and resuming safe driving with its attendant benefits in the realms of family functioning, participation in society and satisfaction with life. The overarching objective of this proposal is to discern, after clinical and simulated driving performance testing , if Occupational Therapy Driving Intervention (OT-DI) can improve the safe driving performance (less errors) over the short term (immediately following intervention) and intermediate term (3 months).
Detailed Description
This research study is being done to determine if Occupational Therapy Driving Intervention (OT-DI) can improve the safe driving performance (less errors) over the short term (immediately following intervention) and intermediate term (3 months). Baseline testing-Pre-test 1-- will include clinical battery of tests and a simulated driving test, a Brief Driving Questionnaire, Community Integration Questionnaire, and a Satisfaction with Life Questionnaire. Caregivers/ family members will rate the participants' driving behaviors using a Fitness-to-Drive Screening Measure( FTDS). After baseline testing the 60 participants (and 60 associated caregivers) will be randomly assigned to a balanced intervention group (15 participants with Traumatic Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and 15 participants with orthopedic conditions and caregivers) and a control group (15 with TBI/PTSD and 15 with orthopedic conditions and caregivers). The intervention group receives Occupational Therapy Driving Intervention (OT-DI), consisting of three x 1 hour sessions will include: Session 1: Driving evaluator reviews explicit driving errors with participants; Session 2: Driving evaluator provide 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 knowledge of the road discussion; Session 3: drive the simulator without any feedback from traffic safety professional). Immediately after session 3, Post-test 1 will occur using the same standardized protocol outlined for baseline testing. Post-test 2 will consist of testing with the same standardized protocol as administered during baseline testing. Caregivers/ family members will rate the participant driving behaviors using the FTDS. In addition, the investigators will obtain driving data from the Department of Motor Vehicles which will include: citations, violations, driving mishaps, and crashes that have occurred for each participant.

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
66 (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 (I-MAP's) clinical battery of tests and a simulated driving test, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, and a Satisfaction with Life Questionnaire. Driving safety professional, three x 1 hour sessions to discuss traffic safety, rules of the road, defensive driving, driving under influence, driver attitudes and safety. Additionally, the study will obtain real world driving data from the Department of Motor Vehicles (public records) which will include citations, violations, and recorded collisions/ crashes.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants in this group will have the following performed: Institute of Mobility Activity and Participation (I-MAP's) clinical battery of tests and a simulated driving test, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, 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 driving simulator with feedback. The study will also obtain real world driving data from the Department of Motor Vehicles (public records) which includes citations, violations, and recorded collisions/crashes.
Arm Title
Caregiver Control Group
Arm Type
Active Comparator
Arm Description
Participants in this group will perform the following: Fitness-to-Drive Screening Measure(FTDS) will be filled out at baseline and again at the end of the study.
Arm Title
Caregiver Experimental Group
Arm Type
Active Comparator
Arm Description
Participants in this group will perform the following: Fitness-to-Drive Screening Measure(FTDS) will be filled out at baseline and again at the end of the study.
Arm Title
Focus Group Discussion Interview Guide
Arm Type
Other
Arm Description
This group will comprise of a subset of the control and experimental groups. A focus group with 8 participants (4 with Traumatic Brain Injury/Post Traumatic Stress Disorder and 4 with orthopedic conditions). The focus group will meet once for a discussion which will be guided with a semi-structured interview that will explore the driving behavior prior to war, during war and post-deployment. Responses will be outlined in an intervention matrix.
Intervention Type
Behavioral
Intervention Name(s)
Driving Behavior Interview
Intervention Description
This will be completed thrice, at baseline, post-test1 and at post-test2
Intervention Type
Behavioral
Intervention Name(s)
Fitness-to-Drive Screening Measure
Intervention Description
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
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, Strength. This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Intervention Type
Behavioral
Intervention Name(s)
Propensity for Angry Driving Scale
Other Intervention Name(s)
Road rage questionnaire
Intervention Description
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Intervention Type
Behavioral
Intervention Name(s)
Community Integration Questionnaire
Intervention Description
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Intervention Type
Behavioral
Intervention Name(s)
Satisfaction with Life Questionnaire
Intervention Description
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Intervention Type
Procedure
Intervention Name(s)
Driving simulator evaluation
Intervention Description
The driving simulator evaluation uses a driving simulator with simulated drives engineered to address Veteran driving concerns such as reactions to other drivers and road conditions (e.g., debris). The simulator is used at baseline and post-tests 1 and 2. The intervention sessions (X3) also occur using simulator.
Intervention Type
Other
Intervention Name(s)
Focus Group Discussion Interview Guide
Intervention Description
Focus group discussion will occur once using the interview guide
Primary Outcome Measure Information:
Title
Driving errors changes between the groups at baseline, months 2 and 3
Description
Determine if the Occupational Therapy Driving Intervention (OT-DI) reduces driving errors in the intervention group.
Time Frame
Changes in baseline months 2 and 3
Secondary Outcome Measure Information:
Title
Perceptions of Combat Veterans regarding driving performance
Description
Semi-structured interview questions will be used to guide the focus group discussions. The results will be outlined in an intervention matrix which will be used to address specific driving errors and the behavior underlying those errors in the intervention process.
Time Frame
Occurs approximately 2 months after baseline (75 minutes)
Title
Change in driving records from baseline and at 11months
Description
Driving records from the Department of Motor Vehicle will be collected to determine if driving errors have reduced.
Time Frame
From baseline (approximately 11months)

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: A combat veteran with polytrauma (mild traumatic brain injury/with an accompanying post traumatic stress disorder (PTSD), traumatic limb amputation/ fractures), who drove prior to the injury/condition; have a valid driver's license or are eligible for a driver's license; are community dwelling; may experience self, physician or other clinical staff identified issues with driving behaviors; have a history of citations, violations or other driving mishaps in real world driving; have potential for following driving safety recommendations (Mini Mental State Examination, (MMSE 24/30); have potential for following community integration strategies (MMSE 24/30); are able to participate in driving evaluation battery. Exclusion Criteria: A combat veteran diagnosed with a severe psychiatric (psychoses) or physical conditions (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, irremediable medical conditions (severe TBI) as per the consulting physician; pregnant females (as determined by a urine test) or those planning pregnancy; VA Employees; and veterans who have received rehabilitation services for TBI/PTSD and who show, as per the screening of the driving rehabilitation specialist, a poor prognosis for improvement based on a driving intervention. Inclusion Criteria for Caregivers: ability to complete a driving questionnaire pre and post intervention. Exclusion Criteria for Caregivers: the presence of a cognitive or physical impairment that would hinder participants ability to complete the questionnaires or make an active contribution.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Winter, 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
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27830643
Citation
Classen S, Winter S, Monahan M, Yarney A, Link Lutz A, Platek K, Levy C. Driving Intervention for Returning Combat Veterans. OTJR (Thorofare N J). 2017 Apr;37(2):62-71. doi: 10.1177/1539449216675582. Epub 2016 Nov 29.
Results Reference
derived

Learn more about this trial

Occupational Therapy Driving Intervention for Returning Combat Veterans.

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