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



Status:Recruiting
Conditions:Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:7/29/2018
Start Date:December 2016
End Date:August 2019
Contact:Sherrilene Classen, PhD
Email:sclassen@phhp.ufl.edu
Phone:(352) 273-6883

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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.

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.

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.
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Gainesville, Florida 32608
Phone: 352-376-1611
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Gainesville, Florida 32610
Phone: 352-273-6817
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