AOD MisusePhase 3BREVALCONCT00658398
The BREVALCO Study, Effect of an Interactive Computer Program to Prevent Alcohol Misuse
A Phase 3 study testing Interactive Computer Program to prevent alcohol misuse. in people with AOD Misuse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AOD Misuse
- What is being tested?
- Interactive Computer Program to prevent alcohol misuse.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.
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.
Read the 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
- Conditions
- AOD Misuse
- Being tested
- Interactive Computer Program to prevent alcohol misuse.
- Keywords
- Alcohol, dependency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Computer Program to prevent alcohol misuse.Behavioural
Interactive Computer Program with questionnaires, video and informations
| Study group | Role | What they receive |
|---|---|---|
| ICP to prevent alcohol misuse. | Experimental | Interactive Computer Program (ICP) to prevent alcohol misuse. Receives: Behavioral: Interactive Computer Program to prevent alcohol misuse. |
| ICP to enhance balanced diet | Sham comparator | 2. Interactive Computer Program to enhance balanced diet (sham intervention) Receives: Behavioral: Interactive Computer Program to prevent alcohol misuse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of alcohol drinks by day in the previous week, at 12months.
Measured: 12 months
Secondary outcomes (8)
the AUDIT score (0-40) at 12 months,
Measured: 12 months
the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months
Measured: 12 months
the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,
Measured: 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,
Measured: 12 months
the percentage of consultations at an ED at 12 months,
Measured: 12 months
the percentage of consultations at hospital at 12 months,
Measured: 12 months
the rate of acceptance of a long-term follow-up
Measured: 12 months
the rate of suicide attempts.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AOD MisuseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel LEJOYEUX, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658398
- Sponsor's protocol ID
- P060252
- Acronym
- BREVALCO
- Status last verified
- Aug 2013
- First submitted
- 9 Apr 2008
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.
- ClinicalTrials.gov ID
- NCT00658398
- Acronym / sponsor ID
- BREVALCO / P060252
- Conditions
- AOD Misuse
- Keywords
- Alcohol, dependency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP to prevent alcohol misuse. | Experimental | Behavioral: Interactive Computer Program to prevent alcohol misuse.Interactive Computer Program (ICP) to prevent alcohol misuse. |
| ICP to enhance balanced diet | Sham comparator | Behavioral: Interactive Computer Program to prevent alcohol misuse.2. Interactive Computer Program to enhance balanced diet (sham intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Computer Program to prevent alcohol misuse.Interactive Computer Program with questionnaires, video and informations | Behavioural | ICP to enhance balanced diet, ICP to prevent alcohol misuse. |
Primary outcome
The mean number of alcohol drinks by day in the previous week, at 12months.
Time frame: 12 months
8 secondary outcomes
the AUDIT score (0-40) at 12 months,
Time frame: 12 months
the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months
Time frame: 12 months
the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,
Time frame: 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,
Time frame: 12 months
the percentage of consultations at an ED at 12 months,
Time frame: 12 months
the percentage of consultations at hospital at 12 months,
Time frame: 12 months
the rate of acceptance of a long-term follow-up
Time frame: 12 months
the rate of suicide attempts.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel LEJOYEUX, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interactive Computer Program to prevent alcohol misuse. in people with AOD Misuse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean number of alcohol drinks by day in the previous week, at 12months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.