Traumatic Brain Injury (TBI)NCT02765672
Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
A study testing Driving Behavior Interview, Clinical Driving Assessment and Propensity for Angry Driving Scale 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
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. 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, Clinical Driving Assessment and Propensity for Angry Driving Scale
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 20 Dec 2023
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
University of Florida, Occupational Therapy Department
Gainesville, Florida, 32610
About this study
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.
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 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.
- Being tested
- Driving Behavior Interview, Clinical Driving Assessment, Propensity for Angry Driving Scale, Community Integration Questionnaire, Satisfaction with Life
- 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 (3 months after post test 1)
Clinical Driving AssessmentOther
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)
Propensity for Angry Driving ScaleBehavioural
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
Community Integration QuestionnaireBehavioural
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
Satisfaction with LifeBehavioural
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1
Fitness-to-Drive Screening Measure (FTDS)Behavioural
Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study
Simulated Driving EvaluationProcedure or surgery
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.
Driving Safety EducationProcedure or surgery
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
Occupational Therapy Driving Intervention (OT-DI)Procedure or surgery
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.
On-road driving testProcedure or surgery
This involves and on-road driving test supervised by Driving Rehabilitation Specialist. To be completed at baseline and at month 5
Driving triggers evaluationProcedure or surgery
The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing
| 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'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. Receives: Behavioral: Driving Behavior Interview; Other: Clinical Driving Assessment; Behavioral: Propensity for Angry Driving Scale; Behavioral: Community Integration Questionnaire; Behavioral: Satisfaction with Life; Behavioral: Fitness-to-Drive Screening Measure (FTDS); Procedure: Simulated Driving Evaluation; Procedure: Driving Safety Education |
| Experimental Group | Experimental | 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. Receives: Behavioral: Driving Behavior Interview; Other: Clinical Driving Assessment; Behavioral: Propensity for Angry Driving Scale; Behavioral: Community Integration Questionnaire; Behavioral: Satisfaction with Life; Behavioral: Fitness-to-Drive Screening Measure (FTDS); Procedure: Simulated Driving Evaluation; Procedure: Occupational Therapy Driving Intervention (OT-DI) |
| Caregiver Control Group | Active comparator | Caregiver control group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study. Receives: Behavioral: Fitness-to-Drive Screening Measure (FTDS) |
| Caregiver Experimental Group | Active comparator | 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. Receives: Behavioral: Fitness-to-Drive Screening Measure (FTDS) |
| On-road driving Group | Active comparator | 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 Receives: Procedure: On-road driving test |
| Simulator-drives Evaluation Group | Active comparator | 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 Receives: Procedure: Driving triggers evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes in baseline at months 2 and 5
Secondary outcomes (1)
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.
Measured: Changes in baseline at months 5
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 startDec 2016
- Primary completion22 Jul 2022
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, VA Office of Research and Development, University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Sherrilene Classen, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765672
- Sponsor's protocol ID
- IRB201500871
- Other IDs
- JW 140063
- Status last verified
- Jan 2024
- First submitted
- 5 May 2016
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
- ClinicalTrials.gov ID
- NCT02765672
- Acronym / sponsor ID
- IRB201500871
- Keywords
- Combat Veterans, Automobile Driving, Fitness to Drive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- United States Department of Defense, VA Office of Research and Development, University of Western Ontario, Canada
- Study start
- Dec 2016 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 20 Dec 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Driving Behavior Interview, Other: Clinical Driving Assessment, Behavioral: Propensity for Angry Driving Scale, Behavioral: Community Integration Questionnaire, Behavioral: Satisfaction with Life, Behavioral: Fitness-to-Drive Screening Measure (FTDS), Procedure: Simulated Driving Evaluation, Procedure: Driving Safety EducationParticipants 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. |
| Experimental Group | Experimental | Behavioral: Driving Behavior Interview, Other: Clinical Driving Assessment, Behavioral: Propensity for Angry Driving Scale, Behavioral: Community Integration Questionnaire, Behavioral: Satisfaction with Life, Behavioral: Fitness-to-Drive Screening Measure (FTDS), Procedure: Simulated Driving Evaluation, Procedure: Occupational Therapy Driving Intervention (OT-DI)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 | Active comparator | Behavioral: Fitness-to-Drive Screening Measure (FTDS)Caregiver control group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study. |
| Caregiver Experimental Group | Active comparator | Behavioral: Fitness-to-Drive Screening Measure (FTDS)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. |
| On-road driving Group | Active comparator | Procedure: On-road driving testA 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 |
| Simulator-drives Evaluation Group | Active comparator | Procedure: Driving triggers evaluationThis 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
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 (3 months after post test 1) | Behavioural | Control Group, Experimental Group |
| Clinical Driving AssessmentClinical 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) | Other | Control Group, Experimental Group |
| Propensity for Angry Driving ScaleThis will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1) | Behavioural | Control Group, Experimental Group |
| Community Integration QuestionnaireThis will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1) | Behavioural | Control Group, Experimental Group |
| Satisfaction with LifeThis will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1 | Behavioural | Control Group, Experimental Group |
| Fitness-to-Drive Screening Measure (FTDS)Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study | Behavioural | Caregiver Control Group, Caregiver Experimental Group, Control Group, Experimental Group |
| Simulated Driving EvaluationThis 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. | Procedure or surgery | Control Group, Experimental Group |
| Driving Safety EducationThis 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 | Procedure or surgery | Control Group |
| Occupational Therapy Driving Intervention (OT-DI)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. | Procedure or surgery | Experimental Group |
| On-road driving testThis involves and on-road driving test supervised by Driving Rehabilitation Specialist. To be completed at baseline and at month 5 | Procedure or surgery | On-road driving Group |
| Driving triggers evaluationThe simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing | Procedure or surgery | Simulator-drives Evaluation Group |
Primary outcome
Simulator driving errors changes within the experimental and control groups at baseline, months 2 and 5
Time frame: Changes in baseline at months 2 and 5
Simulator driving errors will be quantified at baseline and at month 2 and 5 for the experimental and control groups.
1 secondary outcome
On-road driving errors changes within the experimental and control groups at baseline and month 5
Time frame: Changes in baseline at months 5
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 19 Jan 2024.
- 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.
Sherrilene Classen, 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, Clinical Driving Assessment and Propensity for Angry Driving Scale 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 7 inclusion and 5 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 19 Jan 2024. 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?
Simulator driving errors changes within the experimental and control groups at baseline, months 2 and 5 (time frame: Changes in baseline at months 2 and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2024.