The BREVALCO Study, Effect of an Interactive Computer Program to Prevent Alcohol Misuse
BREVALCO
Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.
1 other identifier
interventional
601
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2008
CompletedFirst Posted
Study publicly available on registry
April 15, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 20, 2015
August 1, 2013
3.9 years
April 9, 2008
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean number of alcohol drinks by day in the previous week, at 12months.
12 months
Secondary Outcomes (8)
the AUDIT score (0-40) at 12 months,
12 months
the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months
12 months
the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,
12 months
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
the percentage of consultations at an ED at 12 months,
12 months
- +3 more secondary outcomes
Study Arms (2)
ICP to prevent alcohol misuse.
EXPERIMENTALInteractive Computer Program (ICP) to prevent alcohol misuse.
ICP to enhance balanced diet
SHAM COMPARATOR2\. Interactive Computer Program to enhance balanced diet (sham intervention)
Interventions
Interactive Computer Program with questionnaires, video and informations
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe hospitalier Bichat Claude Bernard
Paris, 75877 cedex 18, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel LEJOYEUX, PH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2008
First Posted
April 15, 2008
Study Start
May 1, 2008
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 20, 2015
Record last verified: 2013-08