Human Risk FactorsNCT02903147
The Efficacy of a Functional Meta-Cognitive Intervention to Improve Human Factors of Professional Drivers
A study testing Functional Meta-Cognitive Intervention and The employer's training in people with Human Risk Factors and Driving Behavior, run by Tel Aviv University.
Trial summary
The objective of the study is to examine the effectiveness of a functional-meta-cognitive intervention program to reduce driving risk factors amongst professional bus drivers. Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Risk Factors, Driving Behavior, Meta-cognition
- What is being tested?
- Functional Meta-Cognitive Intervention and The employer's training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jan 2015
- 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 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male gender.
- Having a valid bus driver's license.
- Working for a specific large bus company in the center of Israel.
Who cannot join
- Drivers who had less than 50 hours of IVDR data were excluded.
About this study
The objective of the study is to examine the effectiveness of a functional-meta-cognitive intervention program to reduce driving risk factors amongst professional bus drivers.
Read the detailed description
In Israel, the percentage of professional drivers involved in lethal car accidents is high in relation to their number on the roads. Every car accident involving a bus driver could potentially put at risk the lives of tens of passengers, and cause damages both direct and indirect at high costs. Due to the high risk of the bus drivers and their passengers, it is highly important to identify and improve the driving characteristics which are necessary for safer driving of said drivers. Many studies have assessed and identified the risk factors of safe driving, but there is relatively little research-based evidence concerning the ability to improve the driving skills of drivers in general and in particular of bus drivers, which are considered a high risk group.
According to the National Road Safety Authority, 88% of road accidents are caused by driver errors. Therefore, the real challenge is to provide a better understanding in the role of human factors in causing road accidents to try and develop a variety of effective interventions to reduce these risk factors. This understanding can contribute both to a better assessment of professional drivers' driving fitness and to intervene accordingly. In this study, we have focused on main aspects that exist in relevant literature and are human risk factors: Cognitive-perceptual, ergonomic and personality risk factors, and checked the connection between these risk factors and actual monitored driving scores as recorder by an In-Vehicle Data Recorder (IVDR). In addition, we examined the effectiveness of a functional-meta-cognitive intervention program designed to increase drivers' awareness to their way of driving. The research model is based on previous driving models and the guiding occupational therapy practice framework model in Israel, while adjusting the model to the professional driving in public transportation line of work and its particular risk factors.
- Conditions
- Human Risk Factors, Driving Behavior, Meta-cognition
- Being tested
- Functional Meta-Cognitive Intervention, The employer's training
- Keywords
- IVDR; driving behavior patterns; Meta-Cognitive Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Meta-Cognitive InterventionBehavioural
Functional-Meta-Cognitive Intervention Program was focused on raising awareness to safe driving risk factors identified at pre-screening, with reference to the difficulties that the driver raises and providing coping strategies. The intervention has been customized for each driver and included three sessions of two hours.
The employer's trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Functional Meta-Cognitive Intervention | Experimental | The intervention is aimed to improve human factors of professional bus drivers Receives: Behavioral: Functional Meta-Cognitive Intervention |
| Control group | Active comparator | The control group had the employer's training - The company holds routine covert inspections, summons to conversations with the security offices and records in the drivers' personal files. Receives: Behavioral: The employer's training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in In Vehicle Data Recorder (IVDR) risk score
Assessing the degree of change in the rate of IVDR events before and after intervention.
Measured: Change from baseline IVDR risk score at 1 year
Secondary outcomes (2)
Change in car accident rate
Assessing the change in the rate of accidents per year before and after the intervention in the intervention group.
Measured: Change from ratings of questionnaire pre intervention to ratings at an average of 1 year post intervention.
Change in subjective ratings of driving performance questionnaire.
Assessing the change in the subjective ratings of the level of performance and of satisfaction with performance before and after the intervention in the intervention group.
Measured: Change from ratings of questionnaire at baseline pre intervention to reratings at an average of 1 year post intervention..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJun 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Risk FactorsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navah Ratzon, Tel Aviv University
- Investigators
- Navah Ratzon, Prof., Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903147
- Sponsor's protocol ID
- Rachel Shichrur
- Other IDs
- Navah Ratzon
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Functional Meta-Cognitive Intervention to Improve Human Factors of Professional Drivers
- ClinicalTrials.gov ID
- NCT02903147
- Acronym / sponsor ID
- Rachel Shichrur
- Conditions
- Human Risk Factors, Driving Behavior, Meta-cognition
- Keywords
- IVDR; driving behavior patterns; Meta-Cognitive Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Sep 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 objective of the study is to examine the effectiveness of a functional-meta-cognitive intervention program to reduce driving risk factors amongst professional bus drivers.
Detailed description
In Israel, the percentage of professional drivers involved in lethal car accidents is high in relation to their number on the roads. Every car accident involving a bus driver could potentially put at risk the lives of tens of passengers, and cause damages both direct and indirect at high costs. Due to the high risk of the bus drivers and their passengers, it is highly important to identify and improve the driving characteristics which are necessary for safer driving of said drivers. Many studies have assessed and identified the risk factors of safe driving, but there is relatively little research-based evidence concerning the ability to improve the driving skills of drivers in general and in particular of bus drivers, which are considered a high risk group.
According to the National Road Safety Authority, 88% of road accidents are caused by driver errors. Therefore, the real challenge is to provide a better understanding in the role of human factors in causing road accidents to try and develop a variety of effective interventions to reduce these risk factors. This understanding can contribute both to a better assessment of professional drivers' driving fitness and to intervene accordingly. In this study, we have focused on main aspects that exist in relevant literature and are human risk factors: Cognitive-perceptual, ergonomic and personality risk factors, and checked the connection between these risk factors and actual monitored driving scores as recorder by an In-Vehicle Data Recorder (IVDR). In addition, we examined the effectiveness of a functional-meta-cognitive intervention program designed to increase drivers' awareness to their way of driving. The research model is based on previous driving models and the guiding occupational therapy practice framework model in Israel, while adjusting the model to the professional driving in public transportation line of work and its particular risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Meta-Cognitive Intervention | Experimental | Behavioral: Functional Meta-Cognitive InterventionThe intervention is aimed to improve human factors of professional bus drivers |
| Control group | Active comparator | Behavioral: The employer's trainingThe control group had the employer's training - The company holds routine covert inspections, summons to conversations with the security offices and records in the drivers' personal files. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male gender.
- Having a valid bus driver's license.
- Working for a specific large bus company in the center of Israel.
Key exclusion criteria (1 listed)
- Drivers who had less than 50 hours of IVDR data were excluded.
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 |
|---|---|---|
| Functional Meta-Cognitive InterventionFunctional-Meta-Cognitive Intervention Program was focused on raising awareness to safe driving risk factors identified at pre-screening, with reference to the difficulties that the driver raises and providing coping strategies. The intervention has been customized for each driver and included three sessions of two hours. | Behavioural | Functional Meta-Cognitive Intervention |
| The employer's training | Behavioural | Control group |
Primary outcome
Change in In Vehicle Data Recorder (IVDR) risk score
Time frame: Change from baseline IVDR risk score at 1 year
Assessing the degree of change in the rate of IVDR events before and after intervention.
2 secondary outcomes
Change in car accident rate
Time frame: Change from ratings of questionnaire pre intervention to ratings at an average of 1 year post intervention.
Change in subjective ratings of driving performance questionnaire.
Time frame: Change from ratings of questionnaire at baseline pre intervention to reratings at an average of 1 year post intervention..
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 16 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Navah Ratzon, Prof. principal investigator
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
A study testing Functional Meta-Cognitive Intervention and The employer's training in people with Human Risk Factors and Driving Behavior, run by Tel Aviv University.
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 3 inclusion and 1 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 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in In Vehicle Data Recorder (IVDR) risk score (time frame: Change from baseline IVDR risk score at 1 year). 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 16 Sep 2016.