Traffic AccidentLESIONATNCT00778440
Risk Level of Suffering From Traffic Injury in Primary Health Care: LESIONAT Project
An observational study of Traffic Accident and Chronic Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traffic Accident, Chronic Disease, Prevalence of Psychoactive Substances in Road Traffic
- How many people
- 1,540 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: drivers with active medical records of 16 years old or more
Who may be able to join
- 16 years old or more
- Catalan and/or spanish language speakers
- Drivers with driver license
- Participation accepted by the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unitat Suport Recerca Barcelona. IDIAP Jordi Go
Barcelona, Barcelona, 08006
About this study
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.
Read the 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
- 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
- Medical subject headings
- Chronic Disease, Wounds and Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traffic AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Unitat de Suport a la Recerca, Barcelona, Spain, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Investigators
- Carlos Martin, MD, PhD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778440
- Sponsor's protocol ID
- PI08/90242
- Acronym
- LESIONAT
- Status last verified
- Aug 2009
- First submitted
- 22 Oct 2008
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20233403
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Level of Suffering From Traffic Injury in Primary Health Care: LESIONAT Project
- ClinicalTrials.gov ID
- NCT00778440
- Acronym / sponsor ID
- LESIONAT / PI08/90242
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,540 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Unitat de Suport a la Recerca, Barcelona, Spain, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- drivers with active medical records of 16 years old or more
Key inclusion criteria (4 listed)
- 16 years old or more
- Catalan and/or spanish language speakers
- Drivers with driver license
- Participation accepted by the patient
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
- Derived from this study: PubMed 20233403Martin-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Martin, MD, PhD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traffic Accident and Chronic Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00778440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.