CClinicalTrials.gg
CompletedNCT02903147Updated Sep 16, 2016

The Efficacy of a Functional Meta-Cognitive Intervention to Improve Human Factors of Professional Drivers

An interventional study of Functional Meta-Cognitive Intervention and The employer's training in Human Risk Factors, Driving Behavior and Meta-cognition, sponsored by Tel Aviv University. Completed. Open to male participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-16.

Sponsored by Tel Aviv University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Non-randomized
Ages
21 Years and older
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Human Risk Factors
  • Driving Behavior
  • Meta-cognition

Keywords

  • IVDR; driving behavior patterns; Meta-Cognitive Intervention
03

In context

Lead sponsor

Tel Aviv University is the lead sponsor of 100 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Drivers who had less than 50 hours of IVDR data were excluded.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Functional Meta-Cognitive Intervention

    The intervention is aimed to improve human factors of professional bus drivers

    Behavioral: Functional Meta-Cognitive Intervention

  • 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.

    Behavioral: The employer's training

Interventions

  • BehavioralFunctional Meta-Cognitive Intervention

    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.

  • BehavioralThe employer's training
06

What researchers measure

Primary outcomes

  1. Change in In Vehicle Data Recorder (IVDR) risk score

    Assessing the degree of change in the rate of IVDR events before and after intervention.

    Time frame: Change from baseline IVDR risk score at 1 year

Secondary outcomes

  1. Change in car accident rate

    Assessing the change in the rate of accidents per year before and after the intervention in the intervention group.

    Time frame: Change from ratings of questionnaire pre intervention to ratings at an average of 1 year post intervention.

  2. 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.

    Time frame: Change from ratings of questionnaire at baseline pre intervention to reratings at an average of 1 year post intervention..

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02903147
Lead sponsor
Tel Aviv University
Responsible party
Navah Ratzon (Professor, Occupational Therapist, Tel Aviv University) — Principal investigator
First posted
Sep 16, 2016
Start date
Jun 2010
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Sep 16, 2016

Study contacts

Navah Ratzon, Prof.
principal investigator · Tel Aviv University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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