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Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks: (IFACAP)

Primary Purpose

Acute Alcohol Intoxication

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized Normative Feedback
Brief Therapeutic Intervention
Evaluation questionnaire
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Alcohol Intoxication

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre Hospitalier Universitaire Amiens Picardie
  • Centre Hospitalier Universitaire Angers
  • Hôpital Saint André
  • Centre Hospitalier Universitaire Rennes Pontchaillou
  • Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Personalized Normative Feedback group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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);
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);
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);
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);
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);
Alcohol related problems
Alcohol related problems in the 6 months and in the year before the evaluations
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.

Full Information

First Posted
February 16, 2017
Last Updated
March 25, 2019
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03059628
Brief Title
Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks:
Acronym
IFACAP
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).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
October 28, 2018 (Actual)
Study Completion Date
October 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Alcohol Intoxication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized Normative Feedback group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Personalized Normative Feedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brief Therapeutic Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluation questionnaire
Intervention Description
The patient have to fill the same evaluation questionnaire at J0, M6 and M12
Primary Outcome Measure Information:
Title
Reduction of the number of heavy drinking occasions
Description
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
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Reduction of the number of standard drinks
Description
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);
Time Frame
at 6 months and at 12 months
Title
Reduction of the number of heavy drinking occasions
Description
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);
Time Frame
at 6 months
Title
Reduction of the number of alcohol intoxications
Description
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);
Time Frame
at 6 months and at 12 months
Title
Reduction of the number of binge drinking
Description
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);
Time Frame
at 6 months and at 12 months
Title
Reduction of total alcohol consumption
Description
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);
Time Frame
at 6 months and at 12 months
Title
Alcohol related problems
Description
Alcohol related problems in the 6 months and in the year before the evaluations
Time Frame
at 6 months and at 12 months
Title
Hospitalisations or admissions in the ED, injuries, violence, unwanted or unprotect sexual behaviours, loss of employment or school problems.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain MOIRAND, MD/PHD
Organizational Affiliation
Rennes Pontchaillou Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Amiens Picardie
City
Amiens
ZIP/Postal Code
84054
Country
France
Facility Name
Centre Hospitalier Universitaire Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
35075
Country
France
Facility Name
Centre Hospitalier Universitaire Rennes Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks:

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