Acute Alcohol IntoxicationIFACAPNCT03059628
Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks:
A study testing Personalized Normative Feedback, Brief Therapeutic Intervention and Evaluation questionnaire in people with Acute Alcohol Intoxication, run by Rennes University Hospital at 5 sites in France.
Trial summary
BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency Department) for acute intoxication to take actions to prevent further alcohol-related issues. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Acute Alcohol Intoxication
- What is being tested?
- Personalized Normative Feedback, Brief Therapeutic Intervention and Evaluation questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 5 sitesFrance
- Study dates
- 22 Sep 2017to 28 Oct 2018
- Phase
- Interventional
- 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 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-26 years;
- Admitted for an acute alcohol intoxication to the ED from Thursday to Sunday;
- Need to be kept in the ED for detoxification;
- Alcohol breath test or blood alcohol concentration if breath test impossible greater than 0.5 gram per liter at the admission to the ED;
- Able to understand and remember the component of the study;
- Use of a smartphone;
- Written informed consent.
Who cannot join
- Patients in police custody and not admitted to emergency;
- Patients admitted for suicidal ideation or attempt;
- Injury requiring an hospitalization;
- Additional need for psychiatric or addiction evaluation;
- Current care in addiction facilities (last contact less than 3 months);
- Planning of a specialized care at the end of the hospitalization;
- Persons participant to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
- Patients participating in another interventional research
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Universitaire Amiens Picardie
Amiens, 84054
Centre Hospitalier Universitaire Angers
Angers, 49933
Hôpital Saint André
Bordeaux, 35075
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000
Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau
Tours, 37044
About this study
Official title: Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks: a Multi Center Randomized Open Study in Young Adults Admitted to Emergency Room for Acute Alcohol Intoxication (AAI).
BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency Department) for acute intoxication to take actions to prevent further alcohol-related issues. The present project aims at underpinning this intervention by actively involving patients in the monitoring of their alcohol-related risk following discharge. While several web-based preventive interventions towards alcohol already exist, the repeated delivering of PNF (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel approach to reduce alcohol-related harms. Investigators propose to test the effect of a mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol intoxication. The mobile PNF will be additionally delivered once a month in the 6-months period after discharge, and once every two months in the following 6-month period, via a smartphone application connected to a central server. The study will include 18-26 years old adults, as this population includes most active students and is often lost to follow-up after ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most of alcohol-related ED visits in this population.
Read the detailed description
The study will begin simultaneously in all the centers, in September, at the beginning of the university year. When patients will be admitted in the ED for alcohol intoxication, they will first meet the entry nurse, who will make the orientation as usual. Participants will be marked as eligible for the study, and a breath test or a blood alcohol test will be performed. On the following morning, a psychologist will evaluate all potential patients, and check the inclusion criteria. In case of eligibility, the study procedure will be explained and the patient and a medical doctor present in the ED will sign an informed consent. The patient will be included and a baseline assessment will be performed using a web-based questionnaire implemented on a digital tablet. These inputs will automatically generate an identification number and a personal dashboard on a centralized server. Individual codes will be also given to each patient for accessing their personal dashboard on the server from a home computer. The patient will then be randomized, with stratification on center, sex, and absence or presence of a daily consumption of cannabis, between the intervention and the control groups. The psychologist will then perform a brief therapeutic intervention for both groups. Investigators plan to train all psychologists all together to the brief intervention. Then a smartphone application will be installed on the patient's smartphone. Follow-up assessments will be conducted 6 and 12 months after baseline using the same questionnaire, through the smartphone application or on the server website. The application will recall the patient by the means of automatic notifications at 6 and 12 months. Data will be push to the server with the identification number, without any other nominal information. In case patients do not perform the evaluation one week after the expected date, they will be contacted by any means (telephone, postal mail, email or SMS with a link to the software) by a research assistant to recall them to do the evaluation. Participants will be compensated using gift vouchers for the time lost for the interview.
Experimental group :
A personalized normative feedback using a tablet application will be performed after the BTI at ED. The application installed on the patient's smartphone will automatically repeat the PNF, using a local algorithm, once a month over a 6-months period after discharge, and once every two months in the following 6-month period. It will be also possible to perform the PNF on the server website.
Control group :
Patients in the control group will receive the BTI at the ED. The application installed on this group will only realize the evaluation questionnaire.
- Conditions
- Acute Alcohol Intoxication
- Being tested
- Personalized Normative Feedback, Brief Therapeutic Intervention, Evaluation questionnaire
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Normative FeedbackOther
This "PNF" technique use information designed to correct normative misperceptions to reduce heavy drinking. Much of the alcohol consumption among college students stems from the fairly widespread perception that one's peers expect regular and sometimes extreme drinking participation (subjective drinking norms). The PNF approach is designed to counter this perception by giving students accurate figures on how much their peers actually drink (actual drinking norms). It also aims to improve students' understanding of alcohol use in general and the firmly established negative outcomes associated with short - and long-term patterns of excessive drinking.
Brief Therapeutic InterventionOther
BTI are brief (typically one session 20-30 mns) and incorporate some or all of the following elements:feedback on the person's alcohol use and any alcohol-related harm; clarification as to what constitutes low risk alcohol consumption; information on the harms associated with risky alcohol use; benefits of reducing intake; motivational enhancement; analysis of high risk situations for drinking and coping strategies; and the development of a personal plan to reduce consumption.
Evaluation questionnaireOther
The patient have to fill the same evaluation questionnaire at J0, M6 and M12
| Study group | Role | What they receive |
|---|---|---|
| Personalized Normative Feedback group | Experimental | A personalized normative feedback using a tablet application will be performed after the BTI at ED. The application installed on the patient's smartphone will automatically repeat the PNF, using a local algorithm, once a month over a 6-months period after discharge, and once every two months in the following 6-month period. It will be also possible to perform the PNF on the server website. Receives: Other: Personalized Normative Feedback; Other: Brief Therapeutic Intervention; Other: Evaluation questionnaire |
| Control group | Other | The control group will not receive further counseling or information after the baseline BTI at ED. The application installed in this group will be only used for the evaluation questionnaire at 6 and 12 months Receives: Other: Brief Therapeutic Intervention; Other: Evaluation questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the number of heavy drinking occasions
Reduction (expressed as a percentage) of the number of heavy drinking occasions (= 7 or more standard drinks of 10 g pure alcohol in one occasion) in the precedent month between baseline (nbaseline) and the evaluation done 12 months after the admission in the ED (n12 months) :
Change = (nbaseline - n12months) / nbaseline
Measured: at 12 months
Secondary outcomes (7)
Reduction of the number of standard drinks
Reduction of the number of standard drinks per heavy drinking occasions in the month before the evaluation (done 6 and 12months after the admission in the ED) versus the number at baseline (in the month before the admission to the ED);
Measured: at 6 months and at 12 months
Reduction of the number of heavy drinking occasions
Reduction of the number of heavy drinking occasions in the month before the evaluation (done 6 months after the admission in the ED) versus the number at baseline (in the month before the admission to the ED);
Measured: at 6 months
Reduction of the number of alcohol intoxications
Reduction of the number of alcohol intoxications (participantively defined by the patient as drunkenness) in the month before the evaluation (done 6 and 12 months after the admission in the ED) versus the number at baseline (in the month before the admission to the ED);
Measured: at 6 months and at 12 months
Reduction of the number of binge drinking
Reduction of the number of binge drinking (see definition above) in the month before the evaluation (done 6 and 12 months after the admission in the ED) versus the number at baseline (in the month before the admission to the ED);
Measured: at 6 months and at 12 months
Reduction of total alcohol consumption
Reduction of total alcohol consumption (in mean standard drinks per week) in the month before the evaluation (done 6 and 12 months after the admission in the ED) versus the number at baseline (in the month before the admission to the ED);
Measured: at 6 months and at 12 months
Alcohol related problems
Alcohol related problems in the 6 months and in the year before the evaluations
Measured: at 6 months and at 12 months
Hospitalisations or admissions in the ED, injuries, violence, unwanted or unprotect sexual behaviours, loss of employment or school problems.
Hospitalisations or admissions in the ED, injuries, violence, unwanted or unprotect sexual behaviours, loss of employment or school problems.
Measured: at 6 months and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start22 Sep 2017
- Primary completion28 Oct 2018
- Study completion28 Oct 2018
Why it stopped: The number of participants included and especially who connected to the application (less than 50% of the target) does not meet the objective set by the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Alcohol IntoxicationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain MOIRAND, MD/PHD, Principal investigator, Rennes Pontchaillou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059628
- Sponsor's protocol ID
- 35RC15_8976_IFACAP
- Acronym
- IFACAP
- Status last verified
- Mar 2019
- First submitted
- 16 Feb 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks: a Multi Center Randomized Open Study in Young Adults Admitted to Emergency Room for Acute Alcohol Intoxication (AAI).
- ClinicalTrials.gov ID
- NCT03059628
- Acronym / sponsor ID
- IFACAP / 35RC15_8976_IFACAP
- Conditions
- Acute Alcohol Intoxication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of participants included and especially who connected to the application (less than 50% of the target) does not meet the objective set by the study.
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 28 Oct 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency Department) for acute intoxication to take actions to prevent further alcohol-related issues. The present project aims at underpinning this intervention by actively involving patients in the monitoring of their alcohol-related risk following discharge. While several web-based preventive interventions towards alcohol already exist, the repeated delivering of PNF (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel approach to reduce alcohol-related harms. Investigators propose to test the effect of a mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol intoxication. The mobile PNF will be additionally delivered once a month in the 6-months period after discharge, and once every two months in the following 6-month period, via a smartphone application connected to a central server. The study will include 18-26 years old adults, as this population includes most active students and is often lost to follow-up after ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most of alcohol-related ED visits in this population.
Detailed description
The study will begin simultaneously in all the centers, in September, at the beginning of the university year. When patients will be admitted in the ED for alcohol intoxication, they will first meet the entry nurse, who will make the orientation as usual. Participants will be marked as eligible for the study, and a breath test or a blood alcohol test will be performed. On the following morning, a psychologist will evaluate all potential patients, and check the inclusion criteria. In case of eligibility, the study procedure will be explained and the patient and a medical doctor present in the ED will sign an informed consent. The patient will be included and a baseline assessment will be performed using a web-based questionnaire implemented on a digital tablet. These inputs will automatically generate an identification number and a personal dashboard on a centralized server. Individual codes will be also given to each patient for accessing their personal dashboard on the server from a home computer. The patient will then be randomized, with stratification on center, sex, and absence or presence of a daily consumption of cannabis, between the intervention and the control groups. The psychologist will then perform a brief therapeutic intervention for both groups. Investigators plan to train all psychologists all together to the brief intervention. Then a smartphone application will be installed on the patient's smartphone. Follow-up assessments will be conducted 6 and 12 months after baseline using the same questionnaire, through the smartphone application or on the server website. The application will recall the patient by the means of automatic notifications at 6 and 12 months. Data will be push to the server with the identification number, without any other nominal information. In case patients do not perform the evaluation one week after the expected date, they will be contacted by any means (telephone, postal mail, email or SMS with a link to the software) by a research assistant to recall them to do the evaluation. Participants will be compensated using gift vouchers for the time lost for the interview.
Experimental group :
A personalized normative feedback using a tablet application will be performed after the BTI at ED. The application installed on the patient's smartphone will automatically repeat the PNF, using a local algorithm, once a month over a 6-months period after discharge, and once every two months in the following 6-month period. It will be also possible to perform the PNF on the server website.
Control group :
Patients in the control group will receive the BTI at the ED. The application installed on this group will only realize the evaluation questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Normative Feedback group | Experimental | Other: Personalized Normative Feedback, Other: Brief Therapeutic Intervention, Other: Evaluation questionnaireA personalized normative feedback using a tablet application will be performed after the BTI at ED. The application installed on the patient's smartphone will automatically repeat the PNF, using a local algorithm, once a month over a 6-months period after discharge, and once every two months in the following 6-month period. It will be also possible to perform the PNF on the server website. |
| Control group | Other | Other: Brief Therapeutic Intervention, Other: Evaluation questionnaireThe control group will not receive further counseling or information after the baseline BTI at ED. The application installed in this group will be only used for the evaluation questionnaire at 6 and 12 months |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-26 years;
- Admitted for an acute alcohol intoxication to the ED from Thursday to Sunday;
- Need to be kept in the ED for detoxification;
- Alcohol breath test or blood alcohol concentration if breath test impossible greater than 0.5 gram per liter at the admission to the ED;
- Able to understand and remember the component of the study;
Key exclusion criteria (8 listed)
- Patients in police custody and not admitted to emergency;
- Patients admitted for suicidal ideation or attempt;
- Injury requiring an hospitalization;
- Additional need for psychiatric or addiction evaluation;
- Current care in addiction facilities (last contact less than 3 months);
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 |
|---|---|---|
| Personalized Normative FeedbackThis "PNF" technique use information designed to correct normative misperceptions to reduce heavy drinking. Much of the alcohol consumption among college students stems from the fairly widespread perception that one's peers expect regular and sometimes extreme drinking participation (subjective drinking norms). The PNF approach is designed to counter this perception by giving students accurate figures on how much their peers actually drink (actual drinking norms). It also aims to improve students' understanding of alcohol use in general and the firmly established negative outcomes associated with short - and long-term patterns of excessive drinking. | Other | Personalized Normative Feedback group |
| Brief Therapeutic InterventionBTI are brief (typically one session 20-30 mns) and incorporate some or all of the following elements:feedback on the person's alcohol use and any alcohol-related harm; clarification as to what constitutes low risk alcohol consumption; information on the harms associated with risky alcohol use; benefits of reducing intake; motivational enhancement; analysis of high risk situations for drinking and coping strategies; and the development of a personal plan to reduce consumption. | Other | Control group, Personalized Normative Feedback group |
| Evaluation questionnaireThe patient have to fill the same evaluation questionnaire at J0, M6 and M12 | Other | Control group, Personalized Normative Feedback group |
Primary outcome
Reduction of the number of heavy drinking occasions
Time frame: at 12 months
Reduction (expressed as a percentage) of the number of heavy drinking occasions (= 7 or more standard drinks of 10 g pure alcohol in one occasion) in the precedent month between baseline (nbaseline) and the evaluation done 12 months after the admission in the ED (n12 months) : Change = (nbaseline - n12months) / nbaseline
7 secondary outcomes
Reduction of the number of standard drinks
Time frame: at 6 months and at 12 months
Reduction of the number of heavy drinking occasions
Time frame: at 6 months
Reduction of the number of alcohol intoxications
Time frame: at 6 months and at 12 months
Reduction of the number of binge drinking
Time frame: at 6 months and at 12 months
Reduction of total alcohol consumption
Time frame: at 6 months and at 12 months
Alcohol related problems
Time frame: at 6 months and at 12 months
Hospitalisations or admissions in the ED, injuries, violence, unwanted or unprotect sexual behaviours, loss of employment or school problems.
Time frame: at 6 months and at 12 months
Results and safety
The study was stopped early (reason given: The number of participants included and especially who connected to the application (less than 50% of the target) does not meet the objective set by the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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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.
Romain MOIRAND, MD/PHD principal investigator
Rennes Pontchaillou Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Normative Feedback, Brief Therapeutic Intervention and Evaluation questionnaire in people with Acute Alcohol Intoxication, run by Rennes University Hospital at 5 sites 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The number of participants included and especially who connected to the application (less than 50% of the target) does not meet the objective set by the study.). Results are not available in the source record.
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?
Reduction of the number of heavy drinking occasions (time frame: at 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 27 Mar 2019.