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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Y

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 Summary:

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, ema
Sponsor: Rennes University Hospital

Current Primary Outcome: Reduction of the number of heavy drinking occasions [ Time Frame: at 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Reduction of the number of standard drinks [ Time Frame: at 6 months and at 12 months ]
  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 [ Time Frame: at 6 months ]
  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 [ Time Frame: at 6 months and at 12 months ]
  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 [ Time Frame: at 6 months and at 12 months ]
  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 [ Time Frame: at 6 months and at 12 months ]
  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 [ Time Frame: at 6 months and at 12 months ]
  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. [ 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.

Original Secondary Outcome: Same as current

Information By: Rennes University Hospital

Dates:
Date Received: February 16, 2017
Date Started: September 2017
Date Completion: June 2019
Last Updated: February 28, 2017
Last Verified: February 2017