Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers (PREVENCON)
Primary Purpose
Alcohol Consumption, Traffic Accident, Risk Perception of Driving After Alcohol Consumption
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Brief intervention
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Consumption focused on measuring Driving, Alcohol consumption, Risk perception
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
- Carlos Martin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brief intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT02150278
First Posted
May 6, 2014
Last Updated
May 28, 2014
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Societat Catalana de Medicina Familiar i Comunitària (CAMFIC), Associació Catalana d'Infermeria (ACI), Associació Catalana d'Infermeria Familiar i Comunitària (AIFIC)
1. Study Identification
Unique Protocol Identification Number
NCT02150278
Brief Title
Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers
Acronym
PREVENCON
Official Title
Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Societat Catalana de Medicina Familiar i Comunitària (CAMFIC), Associació Catalana d'Infermeria (ACI), Associació Catalana d'Infermeria Familiar i Comunitària (AIFIC)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Traffic Accident, Risk Perception of Driving After Alcohol Consumption
Keywords
Driving, Alcohol consumption, Risk perception
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brief intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of driving under the influence of alcohol in the past 30 days
Description
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
Time Frame
up to month 12 post-intervention
Secondary Outcome Measure Information:
Title
Stage of change
Description
: 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
Time Frame
Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.
Title
Regular alcohol consumption
Description
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.
Time Frame
Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Martín_Cantera, MD, PhD
Organizational Affiliation
IDIAP JORDI GOL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carlos Martin
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers
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