NCT02150278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

May 6, 2014

Last Update Submit

May 28, 2014

Conditions

Keywords

DrivingAlcohol consumptionRisk perception

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Stage of change

    Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.

  • Regular alcohol consumption

    Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.

Study Arms (1)

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.

Behavioral: Brief intervention

Interventions

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.

Brief intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlos Martin

Barcelona, Barcelona, Spain

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Carlos Martín_Cantera, MD, PhD

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 29, 2014

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

September 1, 2014

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations