DECORA: Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT04329988

Collaborator

(none)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Unhealthy alcohol use (UAU) is a very important public health concern. In France UAU is the second cause of avoidable death after tobacco smoking. In 2014, 31% of the French adult population presented with unhealthy alcohol use. Primary care practitioners have access to validated questionnaires in French such as the Alcohol Use Disorder Identification Test (AUDIT) and the Fast Alcohol Consumption Evaluation (FACE). These tests are not often used because of their length.

In 2009 a study by Smith et al in the USA compared a single question with the AUDIT-c (a short version of the AUDIT). The single question was "How many times in the past year have you had X or more drinks in a day?" Where X is 7 for men and 6 for women. This study found that the single question had a comparable sensitivity and a specificity, respectively 81,8% and 79,3%.

The aim of the study is to validate this question in French. First the question has been translated from English to French following the WHO method. The aim of the present study is to validate the French translation by comparing it with the AUDIT and the FACE. A questionnaire will be given to patients with inclusion criteria in general practitioners waiting rooms (15 different locations). This questionnaire will be composed of the single question, followed by the AUDIT and FACE, and three socio-demographic questions. The questionnaire will be anonymous.

Condition or Disease	Intervention/Treatment	Phase
Unhealthy Alcohol Use	Other: questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.

Anticipated Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Primary care patients aged 18 or more All patients consulting in a general practitioner office, aged 18 or more, who completed the questionnaire	Other: questionnaire A questionnaire will be made available to all eligible patients in general practitioners waiting rooms. This questionnaire will be composed by the single question, followed by the AUDIT and FACE questionnaires, and three socio-demographic questions. This questionnaire will be anonymous. Patients who agree to fill out a questionnaire will place it in a sealed box once completed.

Arm

Intervention/Treatment

Primary care patients aged 18 or more

All patients consulting in a general practitioner office, aged 18 or more, who completed the questionnaire

Other: questionnaire

A questionnaire will be made available to all eligible patients in general practitioners waiting rooms. This questionnaire will be composed by the single question, followed by the AUDIT and FACE questionnaires, and three socio-demographic questions. This questionnaire will be anonymous. Patients who agree to fill out a questionnaire will place it in a sealed box once completed.

Outcome Measures

Primary Outcome Measures

sensitivity of the single question [At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).]
sensitivity of the single question as measured versus the AUDIT (Alcohol use disorder identification test) Sensitivity = TP/(TP+FN) TP : true positives : people answering 1 or more at the single question and having a score of 8 or more with the AUDIT questionnaire FN : False Negatives : people answering 0 at the single question and having a score of 8 or more with the AUDIT questionnaire TN : True negatives : people answering 0 at the single question and having a score of 7 or less with the AUDIT questionnaire
specificity of the single question [At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).]
specificity of the single question as measured versus the AUDIT (Alcohol use disorder identification test). Specificity = TN/(TN+FP) TP : true positives : people answering 1 or more at the single question and having a score of 8 or more with the AUDIT questionnaire TN : True negatives : people answering 0 at the single question and having a score of 7 or less with the AUDIT questionnaire FP : False positives : people answering 1 or more at the single question and having a score of 7 or less with the AUDIT questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consulting in a general practitioner's office
Over 18 years Old

Exclusion Criteria:

Less than 18 years old
Pregnant women or breast-feeding mothers
People under legal protection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04329988

Other Study ID Numbers:

69HCL19_0889

First Posted:

Apr 1, 2020

Last Update Posted:

Apr 1, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alcohol Drinking

Study Results

No Results Posted as of Apr 1, 2020