The BREVALCO Study, Effect of an Interactive Computer Program to Prevent Alcohol Misuse (BREVALCO)

May 19, 2015 updated by: Assistance Publique - Hôpitaux de Paris

Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.

The purpose of this study is to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.

Design: A randomized controlled trial with patients blinded of study hypotheses. Randomization will be stratified on centers and the sex

Interventions:

Patients randomized in the experimental group will participate in an interactive computer program with video, questionnaires and information related to alcohol misuse. They will also be contacted by phone at 1 month and 3 months to reinforce the effect of the intervention.

Patients randomized in the control group will participate in an interactive computer program with questionnaires and information related to healthy diet. They will also be contacted by phone at 1 month and 3 months to reinforce the effect of the intervention.

Participants: all patients consulting in an emergency department will be screened regarding their alcohol consumption and misuse. All patients screened as having alcohol misuse will be invited to participate in the trial.

Outcomes: the main outcome is the declared alcohol consumption at 12 months. Patients will be evaluated by phone at 3, 6 and 12 months by an independent outcome assessor.

Analyses: An intention to treat analyses will be performed Number of patients: 600 patients will be included Number of centers:3 centres (university hospital) will participate

Study Type

Interventional

Enrollment (Actual)

601

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75877 cedex 18
        • Groupe Hospitalier Bichat Claude Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age >=18
  • patients consulting in an emergency department
  • screened for alcohol misuse or dependence (i.e. for women: AUDIT score>5 or consumption of more than 14 alcohol drinks per week For men: AUDIT score>8 or consumption of more than 7 alcohol drinks per week)
  • informed and signed consent form
  • clinical exam performed
  • having social protection

Exclusion Criteria:

  • vital risk
  • patients having mental disorder,
  • patient unable to answer the questions and to participate in the computer program because of their clinical condition
  • patients no understanding French languages
  • patient already being treated for alcohol disorder
  • patients asking for a specific treatment for their alcohol disorder
  • patients unable to answer to the follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICP to prevent alcohol misuse.
Interactive Computer Program (ICP) to prevent alcohol misuse.
Behavioral: Interactive Computer Program to prevent alcohol misuse.
Interactive Computer Program with questionnaires, video and informations
Sham Comparator: ICP to enhance balanced diet
2. Interactive Computer Program to enhance balanced diet (sham intervention)
Behavioral: Interactive Computer Program to prevent alcohol misuse.
Interactive Computer Program with questionnaires, video and informations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean number of alcohol drinks by day in the previous week, at 12months.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the AUDIT score (0-40) at 12 months,
Time Frame: 12 months
12 months
the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months
Time Frame: 12 months
12 months
the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,
Time Frame: 12 months
12 months
Three numerical scales of social satisfaction (0 to 10) based on health, family life or relationship, occupation or daily activity at 12 months,
Time Frame: 12 months
12 months
the percentage of consultations at an ED at 12 months,
Time Frame: 12 months
12 months
the percentage of consultations at hospital at 12 months,
Time Frame: 12 months
12 months
the rate of acceptance of a long-term follow-up
Time Frame: 12 months
12 months
the rate of suicide attempts.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Michel LEJOYEUX, PH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 15, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P060252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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