- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02903147
The Efficacy of a Functional Meta-Cognitive Intervention to Improve Human Factors of Professional Drivers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male gender.
- Having a valid bus driver's license.
- Working for a specific large bus company in the center of Israel.
Exclusion Criteria:
- Drivers who had less than 50 hours of IVDR data were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Functional Meta-Cognitive Intervention
The intervention is aimed to improve human factors of professional bus drivers
|
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.
|
Active Comparator: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline IVDR risk score at 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in car accident rate
Time Frame: Change from ratings of questionnaire pre intervention to ratings at an average of 1 year post intervention.
|
Assessing the change in the rate of accidents per year before and after the intervention in the intervention group.
|
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..
|
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.
|
Change from ratings of questionnaire at baseline pre intervention to reratings at an average of 1 year post intervention..
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Navah Ratzon, Prof., Tel Aviv University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Rachel Shichrur
- Navah Ratzon (Other Identifier: Pricipal Investigator, Prof)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Human Risk Factors
-
Federico II UniversityCompleted
-
Fundacio d'Investigacio en Atencio Primaria Jordi...SCMFIC FAMILY DOCTORS CATALAN SOCIETY GRANTCompletedCardiovascular Risk FactorsSpain
-
Hypertension Excellence Centre LucerneRecruiting
-
Kuwait Institute for Medical SpecializationPfizerUnknownCardiovascular Risk Factors
-
Arizona State UniversityCompleted
-
Sun Yat-sen UniversityCompleted
-
David Grant U.S. Air Force Medical CenterActive, not recruitingCardiometabolic Risk FactorsUnited States
-
Instituto Mexicano del Seguro SocialUniversity of California, Los Angeles; National Council of Science and Technology...CompletedCardiovascular Risk FactorsMexico
-
Milton S. Hershey Medical CenterTerminated
-
University of MichiganNational Institute on Minority Health and Health Disparities (NIMHD)CompletedCardiovascular Risk FactorsUnited States
Clinical Trials on Functional Meta-Cognitive Intervention
-
University of Western SydneyNational University of MalaysiaCompletedAutism Spectrum DisorderMalaysia
-
Norwegian University of Science and TechnologyWithdrawnSecondary Insomnia
-
Fundació Sant Joan de DéuParc Sanitari Sant Joan de Déu; Corporacion Parc Tauli; Fundació Institut de... and other collaboratorsCompleted
-
Norwegian University of Science and TechnologyPenn State University; University of ManchesterCompletedComparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GADGeneralized Anxiety DisorderNorway
-
KU LeuvenEuropean Social FundCompletedChronic Low Back PainBelgium
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)CompletedAttention Deficit Disorder With HyperactivityUnited States
-
University of Sao PauloRecruitingChronic Low-back PainBrazil
-
University of WashingtonNational Cancer Institute (NCI)CompletedBreast Carcinoma | Cancer Survivor | Malignant Female Reproductive System Neoplasm | Cognitive Side Effects of Cancer TherapyUnited States
-
Vanderbilt UniversityVanderbilt University Medical CenterCompletedBrain Injuries | Dementia | Muscle Disorders | MyopathiesUnited States
-
ANRS, Emerging Infectious DiseasesRecruiting