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

AOD Misuse Clinical Trial

— BREVALCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658398
• Other study ID #: P060252
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: May 19, 2015
• Start date: May 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• AOD Misuse

Intervention

Behavioral:
• Interactive Computer Program to prevent alcohol misuse.
Interactive Computer Program with questionnaires, video and informations

Locations

Country	Name	City	State
France	Groupe hospitalier Bichat Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean number of alcohol drinks by day in the previous week, at 12months.		12 months	No
Secondary	the AUDIT score (0-40) at 12 months,		12 months	No
Secondary	the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months		12 months	No
Secondary	the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,		12 months	No
Secondary	Three numerical scales of social satisfaction (0 to 10) based on health, family life or relationship, occupation or daily activity at 12 months,		12 months	No
Secondary	the percentage of consultations at an ED at 12 months,		12 months	No
Secondary	the percentage of consultations at hospital at 12 months,		12 months	No
Secondary	the rate of acceptance of a long-term follow-up		12 months	No
Secondary	the rate of suicide attempts.		12 months	No