Alcohol Consumption Clinical Trial
— PREVENCONOfficial title:
Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers
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.
Status | Enrolling by invitation |
Enrollment | 120 |
Est. completion date | September 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Carlos Martin | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Jordi Gol i Gurina Foundation | Associació Catalana d'Infermeria (ACI), Associació Catalana d'Infermeria Familiar i Comunitària (AIFIC), Societat Catalana de Medicina Familiar i Comunitària (CAMFIC) |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | up to month 12 post-intervention | No |
Secondary | 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 | Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention. | No |
Secondary | 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. | Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention. | No |
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