Clinical trial NCT02765672: 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
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury (TBI)
Post Traumatic Stress Disorder (PTSD)
Keywords: Combat Veterans
Automobile Driving
Fitness to Drive
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: VA Office of Research and Development
name: University of Western Ontario, Canada
First posted: 2016-05-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Simulator driving errors changes within the experimental and control groups at baseline, months 2 and 5
timeFrame: Changes in baseline at months 2 and 5
Secondary outcomes:
measure: On-road driving errors changes within the experimental and control groups at baseline and month 5
timeFrame: Changes in baseline at months 5
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida, Occupational Therapy Department
state: Florida
Study officials:
affiliation: University of Florida
name: Sherrilene Classen, PhD
role: PRINCIPAL_INVESTIGATOR
References: