Risk Level of Suffering From Traffic Injury in Primary He... | NCT00778440

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Oct 22, 2008

First Submission Date that Met QC Criteria

Oct 22, 2008

First Posted Date

Oct 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2009

Last Update Posted Date

Aug 7, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaOTHER

Collaborators

Name	Class
Unitat de Suport a la Recerca, Barcelona, Spain	OTHER
Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Conditions Module

Conditions

Traffic Accident
Chronic Disease
Prevalence of Psychoactive Substances in Road Traffic
Relative Risk Estimation of Accident for Impaired Drivers

Keywords

Injuries
Traffic Injuries
Preventive medicine
Observational studies
Primary care

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,540Estimated

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

drivers with active medical records of 16 years old or more

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlos Martin, MD, PhD	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unitat Suport Recerca Barcelona. IDIAP Jordi Go		Barcelona	Barcelona	08006	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20233403	Derived	Martin-Cantera C, Prieto-Alhambra D, Roig L, Valiente S, Perez K, Garcia-Ortiz L, Bel J, Marques F, Mundet X, Bonafont X, Birules M, Soldevila N, Briones E; LESIONAT Research Group. Risk levels for suffering a traffic injury in primary health care. The LESIONAT project. BMC Public Health. 2010 Mar 16;10:136. doi: 10.1186/1471-2458-10-136.

ID	Term
D002908	Chronic Disease
D014947	Wounds and Injuries

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms