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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00778440
Other study ID # PI08/90242
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 22, 2008
Last updated August 6, 2009
Start date January 2009
Est. completion date September 2009

Study information

Verified date August 2009
Source Jordi Gol i Gurina Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Observational

Clinical Trial Summary

Main objectives:

- To know the distribution of risk elements of traffic injuries

Secondary objectives:

- To study the distribution of risk elements related with the possibility of suffering from a TI in relation to medication, chronic health problems, and consumption of psychoactive substances (alcohol and others).

- To know the relation between levels of perception of risk of suffering from a TI and the presence of chronic problems, medications, or consumption of psychoactive substances.


Description:

Methodology:

Design: Observational, transversal, and multicentric research

Field of study: 20 PHC users from urban areas

Population of study: random consecutive sampling of ≥ 16 years old drivers with open medical history.

Measure's tools: Two means for data collection: survey among health professionals with medical history and structured telephonic survey about behaviours and risk perceptions in drivers.

Variables: Sociodemographic data, chronic pathologies related to TI, consumption of medications ,Alcohol consumption (AUDIT-C test), Psychoactive substances consumption (self declared), Level of perception of risk according to professionals.

Telephone survey: Class and age of driving license, Type of roads, Weekly driving time, Safety behaviours, Record of collisions/injuries in last year,Self perception of health level(SF-12) andSelf perception of risk level.

An descriptive analysis of population will be performed, a distribution of risk elements associated to TI will be described through bivariant analyses, and for describing the factors associated to perceived risk levels a linear regression multiple model will be built.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1540
Est. completion date September 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- 16 years old or more

- Catalan and/or spanish language speakers

- Drivers with driver license

- Participation accepted by the patient

Exclusion Criteria:

- Patients who do not have contact phone number.

- Patients who do not answer up to 3 phone calls

- Patients with severe mental or physical health disorder

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Unitat Suport Recerca Barcelona. IDIAP Jordi Go Barcelona

Sponsors (3)

Lead Sponsor Collaborator
Jordi Gol i Gurina Foundation Catalan Society of Family Medicine, Unitat de Suport a la Recerca, Barcelona, Spain

Country where clinical trial is conducted

Spain, 

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