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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02903147
Other study ID # Rachel Shichrur
Secondary ID Navah Ratzon
Status Completed
Phase N/A
First received September 7, 2016
Last updated September 15, 2016
Start date June 2010
Est. completion date January 2015

Study information

Verified date September 2016
Source Tel Aviv University
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Functional 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.
The employer's training


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tel Aviv University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in In Vehicle Data Recorder (IVDR) risk score Assessing the degree of change in the rate of IVDR events before and after intervention. Change from baseline IVDR risk score at 1 year No
Secondary Change in car accident rate 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. No
Secondary 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. Change from ratings of questionnaire at baseline pre intervention to reratings at an average of 1 year post intervention.. No
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