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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: AOD Misuse

Treatments: Behavioral: Interactive Computer Program to prevent alcohol misuse.

Study type: Interventional

Funder types: Other

Identifiers

NCT00658398

P060252

Details and patient eligibility

About

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.

Full 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

Enrollment: 601 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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601 participants in 2 patient groups

ICP to prevent alcohol misuse.

Experimental group

Description:

Interactive Computer Program (ICP) to prevent alcohol misuse.

Treatment:

Behavioral: Interactive Computer Program to prevent alcohol misuse.

ICP to enhance balanced diet

Sham Comparator group

Description:

2. Interactive Computer Program to enhance balanced diet (sham intervention)

Treatment:

Behavioral: Interactive Computer Program to prevent alcohol misuse.