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.
IFACAP
Sponsor study identifier
interventional
222
1 country
5
Study Start
September 22, 2017
Actual (reported)Primary Completion
October 28, 2018
Actual (reported)Study Completion
October 28, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 28, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 16, 2017
Actual (reported)February 23, 2017
Actual (reported)September 22, 2017
Actual (reported)October 28, 2018
Actual (reported)October 28, 2018
Actual (reported)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
at 12 months
Reduction of the number of standard drinks
at 6 months and at 12 months
Reduction of the number of heavy drinking occasions
at 6 months
Reduction of the number of alcohol intoxications
at 6 months and at 12 months
Reduction of the number of binge drinking
at 6 months and at 12 months
Reduction of total alcohol consumption
at 6 months and at 12 months
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
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.
Centre Hospitalier Universitaire Amiens Picardie
Amiens, 84054, France
Centre Hospitalier Universitaire Angers
Angers, 49933, France
Hôpital Saint André
Bordeaux, 35075, France
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau
Tours, 37044, France
Romain MOIRAND, MD/PHD
Rennes Pontchaillou Hospital
222 participants (actual enrollment reported by the registry).
First Submitted
February 16, 2017
First Posted
February 23, 2017
Study Start
September 22, 2017
Actual (reported)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.
The patient have to fill the same evaluation questionnaire at J0, M6 and M12
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 28, 2018
Actual (reported)Study Completion
October 28, 2018
Actual (reported)Last Updated
March 27, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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