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

NCT03059628 | Terminated

• 1 other identifier: 35RC15_8976_IFACAP
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Alcohol Intoxication

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

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.

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

Other: Brief Therapeutic Intervention; Other: Evaluation questionnaire

Interventions

Personalized Normative Feedback OTHER

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.

Personalized Normative Feedback group

Brief Therapeutic Intervention OTHER

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.

Control group; Personalized Normative Feedback group

Evaluation questionnaire OTHER

The patient have to fill the same evaluation questionnaire at J0, M6 and M12

Control group; Personalized Normative Feedback group

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (5)

Centre Hospitalier Universitaire Amiens Picardie

Amiens, 84054, France

Location

Centre Hospitalier Universitaire Angers

Angers, 49933, France

Location

Hôpital Saint André

Bordeaux, 35075, France

Location

Centre Hospitalier Universitaire Rennes Pontchaillou

Rennes, 35000, France

Location

Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau

Tours, 37044, France

Location

MeSH Terms

Conditions

Alcoholic Intoxication

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Romain MOIRAND, MD/PHD

  Rennes Pontchaillou Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: September 22, 2017
• Primary Completion: October 28, 2018
• Study Completion: October 28, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

FR (5)