The BREVALCO Study, Effect of an Interactive Computer Program to Prevent Alcohol Misuse - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00658398

Purpose

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	Intervention	Phase
Alcohol Misuse	Behavioral: Interactive Computer Program to prevent alcohol misuse.	Phase III

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Declared alcohol consumption at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AUDIT score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Rapid drug and alcohol problems screen (RDAPS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
DSM-IV alcohol and dependence criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
social functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of consultations in an emergency service, admission in hospital and suicide attempt. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Interactive Computer Program to prevent alcohol misuse.	Behavioral: Interactive Computer Program to prevent alcohol misuse. Interactive Computer Program with questionnaires, video and informations
2: Sham Comparator 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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658398

Contacts

Contact: Michel Lejoyeux, Pr

01 40 25 82 62 ext 33 (0)

michel.lejoyeux@bch.aphp.fr

Locations

France
Groupe hospitalier Bichat Claude Bernard	Recruiting
Paris, France, 75877 cedex 18
Contact: Michel Lejoyeux, Pr 01 40 25 82 62 ext 33 (0) michel.lejoyeux@bch.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Michel LEJOYEUX, PH

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Departement Clinical research ( Cécile Jourdain )
Study ID Numbers:	P060252
Study First Received:	April 9, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00658398
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Alcohol
dependency

Study placed in the following topic categories:

Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009