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

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ClinicalTrials.gov Identifier: NCT00658398
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
AOD Misuse Behavioral: Interactive Computer Program to prevent alcohol misuse. Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.
Study Start Date : May 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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




Primary Outcome Measures :
  1. The mean number of alcohol drinks by day in the previous week, at 12months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658398


Locations
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France
Groupe hospitalier Bichat Claude Bernard
Paris, France, 75877 cedex 18
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Michel LEJOYEUX, PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00658398     History of Changes
Other Study ID Numbers: P060252
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: August 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alcohol
dependency
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs