Health and Road Safety: Influence of Drugs Use and Health Status

NCT ID: NCT02688504

Last Updated: 2020-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-18

Study Completion Date

2018-12-26

Brief Summary

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In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.

When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization \> 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.

This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.

This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization \< 24 hours) that represent around 73% of accidents.

Detailed Description

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Conditions

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Car Accident

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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serious road accidents

Drivers involved in serious road accidents (hospitalization \> 24 hours)

No interventions assigned to this group

non-serious road accidents

drivers involved in non-serious road accidents (hospitalization \< 24 hours).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Driver involved in a road accident and admitted in an emergency department
* Aged over 18 years
* Able to respond to a structured questionnaire
* Having agreed to participate in the study

Exclusion Criteria

* Minors
* Passenger
* Pedestrian
* Discharge or transfer to another hospital/clinic before the interview
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicholas MOORE, Pr

Role: STUDY_CHAIR

Plateforme BPE

Locations

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Hôpital Pellegrin

Bordeaux, , France

Site Status

CH de Perigueux

Périgueux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2012/33

Identifier Type: -

Identifier Source: org_study_id

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