Alcohol ConsumptionPREVENCONNCT02150278
Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers
A study testing Brief intervention in people with Alcohol Consumption and Traffic Accident, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Objectives: The main objective of this pilot study is to assess the feasibility and effectiveness of a brief intervention to reduce drinking-driving behavior. Methods: Design: Pilot multicentre before/after intervention study without control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Consumption, Traffic Accident, Risk Perception of Driving After Alcohol Consumption
- What is being tested?
- Brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to Sep 2014
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- drivers with driving license of any vehicle with current validity
- People aged 18 to 65 years
- People attended Primary Health Care reported having consumed any alcohol at least one time before driving the 30 days prior
Who cannot join
- People advise against that approach: severe psychiatric illnesses and terminals
- Patients with a diagnosis of alcohol dependence
- Difficulty communication language
- Unstable demographic status: People residing outside the study area, traffic situation
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: The main objective of this pilot study is to assess the feasibility and effectiveness of a brief intervention to reduce drinking-driving behavior.
Methods:
Read more
Design: Pilot multicentre before/after intervention study without control group. Participants: We aim to recruit, from 01/01/2013 to 01/05/2013, 212 drivers aged 18 to 65 who declared to have consumed alcohol previous to driving, at least once in the past 30 days. Intervention: Brief behavioral intervention to reduce alcohol consumption before driving. Outcomes: Frequency of driving under the influence of alcohol in the past 30 days, regular alcohol consumption (Audit-C test), level of self-efficacy and stage of change according to the Prochaska and DiClemente's Transtheoretical Model of Change, sociodemographic variables, driver's profile, chronic pathologies, long -term medications, level of self risk perception. Information will be checked against medical record. Information on a) frequency of driving under the influence of alcohol in the past 30 days, b) regular alcohol and c) level of self-efficacy and stet of change according Prochaska State will be gathered at one month and 12 month post intervention. Descriptive bivariate analysis to assess the distribution of risk elements associated to drinking-driving behavior.
Potential impact expected: This pilot project will determine the feasibility of making a brief advice intervention in drivers under the influence of alcohol in primary care.
Read the detailed description
Background: Driving under the influence of alcohol is one of the main risk factors for road traffic collisions since it alters driving ability and impairs human performance. Consequently, is very important to identify those drivers who drive under the influence of alcohol; furthermore, interventions are necessary to diminish drinking-driving behavior.
Objectives: The main objective of this pilot study is to assess the feasibility and effectiveness of a brief intervention to reduce drinking-driving behavior.
Secondary objectives include:
- To assess the effect of the intervention on stage of change and level of self-efficacy, at month 1 and 12 post-intervention.
- To assess the feasibility of this intervention by professionals and patients.
- To assess the effectiveness of decreasing the regular alcohol consumption at month 12 post-intervention.
Methods:
Design: Pilot multicentre before/after intervention study without control group.
Participants: We aim to recruit 212 participants. We included by random consecutive sampling drivers (with a valid driver's license) aged 18 to 65 with an open medical history in any of the 20 Primary Health Care participating centers and who declared to have consumed alcohol previous to driving, at least once in the past 30 days. Recruitment took place from xxx 2013 to xxx 213.
Intervention: Brief behavioral intervention to reduce alcohol consumption before driving.
Measurements:
At baseline, the following information will be gathered using a structured questionnaire in the face to face interview between the patient and the health professional:
- Frequency of driving under the influence of alcohol in the past 30 days. gathered as a) the number of times that the patient drinks any amount of alcohol previous to driving and b) the amount alcohol consumed previous to driving
- Regular alcohol consumption (Audit-C test) in units of standard drinks weekly consumed (UBE).
- Level of self-efficacy and stage of change according to the Prochaska and DiClemente's Transtheoretical Model of Change.
- Sociodemographic variables: age, sex, social class, educational level, marital status.
- Driver profile: Type of driver's license, driving experience, , weekly driving time, safety behaviours, collisions (with and without injury) suffered in the past year.
- Chronic pathologies and chronic consumption of medications associated to road traffic injuries
- Level of self risk perception. When possible, all the information will be checked with that specified in the electronical medical record of the patient.
In order to assess the feasibility of the intervention we will undertake a survey among health professionals.
Information on a) frequency of driving under the influence of alcohol in the past 30 days, b) regular alcohol and c) level of self-efficacy and stet of change according Prochaska State will be gathered at one month and 12 month post intervention.
Analysis: A descriptive analysis of population will be performed. The distribution of risk elements associated to drinking-driving behavior will be described through bivariate analyses.
Potential impact expected:
This pilot project will determine the feasibility of making a brief advice intervention in drinking-driving behavior drivers attended in primary care.
- Conditions
- Alcohol Consumption, Traffic Accident, Risk Perception of Driving After Alcohol Consumption
- Being tested
- Brief intervention
- Keywords
- Driving, Alcohol consumption, Risk perception
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
The brief intervention consist of one face to face minimal advice to reduce drinking-driving behavior and it was personalized according to the state of change of the patient (based on the Prochaska and DiClemente model). An additional informative pamphlet is offered to the participant. The intervention was done by the general practitioner or nurse that regularly attends the patient.
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention | Experimental | The brief intervention consist of one face to face minimal advice to reduce drinking-driving behavior and it was personalized according to the state of change of the patient (based on the Prochaska and DiClemente model). An additional informative pamphlet is offered to the participant. The intervention was done by the general practitioner or nurse that regularly attends the patient. Receives: Behavioral: Brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of driving under the influence of alcohol in the past 30 days
We will gather a) the number of times that the patient drinks any amount of alcohol previous to driving and b) the amount alcohol consumed previous to driving
Measured: up to month 12 post-intervention
Secondary outcomes (2)
Stage of change
: Stage of change according to the Prochaska and DiClemente's Transtheoretical Model of Change, also called The Transtheoretical Model (TTM) wich assumes that individuals change habitual behaviors through a cyclical process. It includes the following stages: precontemplation, contemplation, preparation and action, among others
Measured: Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.
Regular alcohol consumption
Regular alcohol consumption according to the Audit-C test in units of standard drinks weekly consumed (UBE). Information will be checked against patient's medical record.
Measured: Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Associació Catalana d'Infermeria (ACI), Associació Catalana d'Infermeria Familiar i Comunitària (AIFIC)
- Responsible party
- Sponsor
- Investigators
- Carlos Martín_Cantera, MD, PhD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150278
- Sponsor's protocol ID
- PREVENCON
- Acronym
- PREVENCON
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers
- ClinicalTrials.gov ID
- NCT02150278
- Acronym / sponsor ID
- PREVENCON / PREVENCON
- Conditions
- Alcohol Consumption, Traffic Accident, Risk Perception of Driving After Alcohol Consumption
- Keywords
- Driving, Alcohol consumption, Risk perception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Associació Catalana d'Infermeria (ACI), Associació Catalana d'Infermeria Familiar i Comunitària (AIFIC)
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2014 (estimated)
- First posted
- 29 May 2014 (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.
Objectives: The main objective of this pilot study is to assess the feasibility and effectiveness of a brief intervention to reduce drinking-driving behavior.
Methods:
Design: Pilot multicentre before/after intervention study without control group. Participants: We aim to recruit, from 01/01/2013 to 01/05/2013, 212 drivers aged 18 to 65 who declared to have consumed alcohol previous to driving, at least once in the past 30 days. Intervention: Brief behavioral intervention to reduce alcohol consumption before driving. Outcomes: Frequency of driving under the influence of alcohol in the past 30 days, regular alcohol consumption (Audit-C test), level of self-efficacy and stage of change according to the Prochaska and DiClemente's Transtheoretical Model of Change, sociodemographic variables, driver's profile, chronic pathologies, long -term medications, level of self risk perception. Information will be checked against medical record. Information on a) frequency of driving under the influence of alcohol in the past 30 days, b) regular alcohol and c) level of self-efficacy and stet of change according Prochaska State will be gathered at one month and 12 month post intervention. Descriptive bivariate analysis to assess the distribution of risk elements associated to drinking-driving behavior.
Potential impact expected: This pilot project will determine the feasibility of making a brief advice intervention in drivers under the influence of alcohol in primary care.
Detailed description
Background: Driving under the influence of alcohol is one of the main risk factors for road traffic collisions since it alters driving ability and impairs human performance. Consequently, is very important to identify those drivers who drive under the influence of alcohol; furthermore, interventions are necessary to diminish drinking-driving behavior.
Objectives: The main objective of this pilot study is to assess the feasibility and effectiveness of a brief intervention to reduce drinking-driving behavior.
Secondary objectives include:
- To assess the effect of the intervention on stage of change and level of self-efficacy, at month 1 and 12 post-intervention.
- To assess the feasibility of this intervention by professionals and patients.
- To assess the effectiveness of decreasing the regular alcohol consumption at month 12 post-intervention.
Methods:
Design: Pilot multicentre before/after intervention study without control group.
Participants: We aim to recruit 212 participants. We included by random consecutive sampling drivers (with a valid driver's license) aged 18 to 65 with an open medical history in any of the 20 Primary Health Care participating centers and who declared to have consumed alcohol previous to driving, at least once in the past 30 days. Recruitment took place from xxx 2013 to xxx 213.
Intervention: Brief behavioral intervention to reduce alcohol consumption before driving.
Measurements:
At baseline, the following information will be gathered using a structured questionnaire in the face to face interview between the patient and the health professional:
- Frequency of driving under the influence of alcohol in the past 30 days. gathered as a) the number of times that the patient drinks any amount of alcohol previous to driving and b) the amount alcohol consumed previous to driving
- Regular alcohol consumption (Audit-C test) in units of standard drinks weekly consumed (UBE).
- Level of self-efficacy and stage of change according to the Prochaska and DiClemente's Transtheoretical Model of Change.
- Sociodemographic variables: age, sex, social class, educational level, marital status.
- Driver profile: Type of driver's license, driving experience, , weekly driving time, safety behaviours, collisions (with and without injury) suffered in the past year.
- Chronic pathologies and chronic consumption of medications associated to road traffic injuries
- Level of self risk perception. When possible, all the information will be checked with that specified in the electronical medical record of the patient.
In order to assess the feasibility of the intervention we will undertake a survey among health professionals.
Information on a) frequency of driving under the influence of alcohol in the past 30 days, b) regular alcohol and c) level of self-efficacy and stet of change according Prochaska State will be gathered at one month and 12 month post intervention.
Analysis: A descriptive analysis of population will be performed. The distribution of risk elements associated to drinking-driving behavior will be described through bivariate analyses.
Potential impact expected:
This pilot project will determine the feasibility of making a brief advice intervention in drinking-driving behavior drivers attended in primary care.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief intervention | Experimental | Behavioral: Brief interventionThe brief intervention consist of one face to face minimal advice to reduce drinking-driving behavior and it was personalized according to the state of change of the patient (based on the Prochaska and DiClemente model). An additional informative pamphlet is offered to the participant. The intervention was done by the general practitioner or nurse that regularly attends the patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- drivers with driving license of any vehicle with current validity
- People aged 18 to 65 years
- People attended Primary Health Care reported having consumed any alcohol at least one time before driving the 30 days prior
Key exclusion criteria (4 listed)
- People advise against that approach: severe psychiatric illnesses and terminals
- Patients with a diagnosis of alcohol dependence
- Difficulty communication language
- Unstable demographic status: People residing outside the study area, traffic situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief interventionThe brief intervention consist of one face to face minimal advice to reduce drinking-driving behavior and it was personalized according to the state of change of the patient (based on the Prochaska and DiClemente model). An additional informative pamphlet is offered to the participant. The intervention was done by the general practitioner or nurse that regularly attends the patient. | Behavioural | Brief intervention |
Primary outcome
Frequency of driving under the influence of alcohol in the past 30 days
Time frame: up to month 12 post-intervention
We will gather a) the number of times that the patient drinks any amount of alcohol previous to driving and b) the amount alcohol consumed previous to driving
2 secondary outcomes
Stage of change
Time frame: Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.
Regular alcohol consumption
Time frame: Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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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 Martín_Cantera, 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?
A study testing Brief intervention in people with Alcohol Consumption and Traffic Accident, 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 3 inclusion and 4 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 29 May 2014. 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.
What does the primary outcome measure?
Frequency of driving under the influence of alcohol in the past 30 days (time frame: up to month 12 post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2014.