Traumatic Brain Injury (TBI)NCT02764983
Occupational Therapy Driving Intervention for Returning Combat Veterans.
A study testing Driving Behavior Interview, Fitness-to-Drive Screening Measure and Clinical Driving Assessment in people with Traumatic Brain Injury (TBI) and Post Traumatic Stress Disorder (PTSD), run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traumatic Brain Injury (TBI), Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Driving Behavior Interview, Fitness-to-Drive Screening Measure and Clinical Driving Assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- have potential for following community integration strategies (MMSE 24/30);
- are able to participate in driving evaluation battery.
- ability to complete a driving questionnaire pre and post intervention.
Who cannot join
- 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.
- the presence of a cognitive or physical impairment that would hinder participants ability to complete the questionnaires or make an active contribution.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
University of Florida
Gainesville, Florida, 32610
About this study
Official title: Efficacy of a Driving Program on Safe Community Mobility for Combat Veterans
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).
Read the 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.
- Being tested
- Driving Behavior Interview, Fitness-to-Drive Screening Measure, Clinical Driving Assessment, Propensity for Angry Driving Scale, Community Integration Questionnaire
- Keywords
- Combat Veterans, Automobile Driving, Fitness to Drive
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving Behavior InterviewBehavioural
This will be completed thrice, at baseline, post-test1 and at post-test2
Fitness-to-Drive Screening MeasureBehavioural
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Clinical Driving AssessmentOther
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)
Propensity for Angry Driving ScaleBehavioural
Also called Road rage questionnaire
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Community Integration QuestionnaireBehavioural
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Satisfaction with Life QuestionnaireBehavioural
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Driving simulator evaluationProcedure or surgery
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.
Focus Group Discussion Interview GuideOther
Focus group discussion will occur once using the interview guide
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Behavioral: Driving Behavior Interview; Behavioral: Fitness-to-Drive Screening Measure; Other: Clinical Driving Assessment; Behavioral: Propensity for Angry Driving Scale; Behavioral: Community Integration Questionnaire; Behavioral: Satisfaction with Life Questionnaire; Procedure: Driving simulator evaluation |
| Experimental Group | Experimental | 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. Receives: Behavioral: Driving Behavior Interview; Behavioral: Fitness-to-Drive Screening Measure; Other: Clinical Driving Assessment; Behavioral: Propensity for Angry Driving Scale; Behavioral: Community Integration Questionnaire; Behavioral: Satisfaction with Life Questionnaire; Procedure: Driving simulator evaluation |
| Caregiver Control Group | Active comparator | 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. Receives: Behavioral: Fitness-to-Drive Screening Measure |
| Caregiver Experimental Group | Active comparator | 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. Receives: Behavioral: Fitness-to-Drive Screening Measure |
| Focus Group Discussion Interview Guide | Other | 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. Receives: Other: Focus Group Discussion Interview Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes in baseline months 2 and 3
Secondary outcomes (2)
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.
Measured: Occurs approximately 2 months after baseline (75 minutes)
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.
Measured: From baseline (approximately 11months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJan 2013
- Primary completionSep 2015
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs, University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Sandra Winter, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764983
- Sponsor's protocol ID
- 652-2011
- Other IDs
- IRB201702264, JW140063
- Status last verified
- Dec 2018
- First submitted
- 18 Apr 2016
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27830643
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Driving Program on Safe Community Mobility for Combat Veterans
- ClinicalTrials.gov ID
- NCT02764983
- Acronym / sponsor ID
- 652-2011
- Keywords
- Combat Veterans, Automobile Driving, Fitness to Drive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs, University of Western Ontario, Canada
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Driving Behavior Interview, Behavioral: Fitness-to-Drive Screening Measure, Other: Clinical Driving Assessment, Behavioral: Propensity for Angry Driving Scale, Behavioral: Community Integration Questionnaire, Behavioral: Satisfaction with Life Questionnaire, Procedure: Driving simulator evaluationParticipants 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. |
| Experimental Group | Experimental | Behavioral: Driving Behavior Interview, Behavioral: Fitness-to-Drive Screening Measure, Other: Clinical Driving Assessment, Behavioral: Propensity for Angry Driving Scale, Behavioral: Community Integration Questionnaire, Behavioral: Satisfaction with Life Questionnaire, Procedure: Driving simulator evaluationParticipants 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. |
| Caregiver Control Group | Active comparator | Behavioral: Fitness-to-Drive Screening MeasureParticipants 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. |
| Caregiver Experimental Group | Active comparator | Behavioral: Fitness-to-Drive Screening MeasureParticipants 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. |
| Focus Group Discussion Interview Guide | Other | Other: Focus Group Discussion Interview GuideThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving Behavior InterviewThis will be completed thrice, at baseline, post-test1 and at post-test2 | Behavioural | Control Group, Experimental Group |
| Fitness-to-Drive Screening MeasureThis will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1) | Behavioural | Caregiver Control Group, Caregiver Experimental Group, Control Group, Experimental Group |
| Clinical Driving AssessmentClinical 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) | Other | Control Group, Experimental Group |
| Propensity for Angry Driving ScaleAlso: Road rage questionnaireThis questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1) | Behavioural | Control Group, Experimental Group |
| Community Integration QuestionnaireThis questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1) | Behavioural | Control Group, Experimental Group |
| Satisfaction with Life QuestionnaireThis questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1) | Behavioural | Control Group, Experimental Group |
| Driving simulator evaluationThe 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. | Procedure or surgery | Control Group, Experimental Group |
| Focus Group Discussion Interview GuideFocus group discussion will occur once using the interview guide | Other | Focus Group Discussion Interview Guide |
Primary outcome
Driving errors changes between the groups at baseline, months 2 and 3
Time frame: Changes in baseline months 2 and 3
Determine if the Occupational Therapy Driving Intervention (OT-DI) reduces driving errors in the intervention group.
2 secondary outcomes
Perceptions of Combat Veterans regarding driving performance
Time frame: Occurs approximately 2 months after baseline (75 minutes)
Change in driving records from baseline and at 11months
Time frame: From baseline (approximately 11months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Derived from this study: PubMed 27830643Classen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Winter, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving Behavior Interview, Fitness-to-Drive Screening Measure and Clinical Driving Assessment in people with Traumatic Brain Injury (TBI) and Post Traumatic Stress Disorder (PTSD), run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving errors changes between the groups at baseline, months 2 and 3 (time frame: Changes in baseline months 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.