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Completed

NCT Number: NCT00658398

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Groupe hospitalier Bichat Claude Bernard

Paris, 75877 cedex 18, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive Computer Program to prevent alcohol misuse.

Behavioral

Interactive Computer Program with questionnaires, video and informations

Primary outcomes

  1. The mean number of alcohol drinks by day in the previous week, at 12months.

    Time frame: 12 months

Secondary outcomes

  1. the AUDIT score (0-40) at 12 months,

    Time frame: 12 months

  2. the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months

    Time frame: 12 months

  3. the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,

    Time frame: 12 months

  4. 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

  5. the percentage of consultations at an ED at 12 months,

    Time frame: 12 months

  6. the percentage of consultations at hospital at 12 months,

    Time frame: 12 months

  7. the rate of acceptance of a long-term follow-up

    Time frame: 12 months

  8. the rate of suicide attempts.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: BREVALCO

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 15, 2008
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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