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CompletedNCT04329988DECORAUpdated Sep 26, 2022

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

An observational study in Unhealthy Alcohol Use, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-26.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
394
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Unhealthy Alcohol Use

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03

In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's enrollment of 394 is above the median of 227 across 90 observational studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

General population consulting in a primary care office over 18 years old.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
394 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Otherquestionnaire

    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.

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What researchers measure

Primary outcomes

  1. sensitivity of the single question

    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

    Time frame: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).

  2. specificity of the single question

    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

    Time frame: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).

07

Study locations

1 site
  • Cabinet de Médecine Générale Dr Christine Maynie-François
    Saint-Quentin-Fallavier, 38070, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04329988
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 1, 2020
Start date
May 28, 2020
Primary completion
Dec 18, 2020
Completion
Dec 18, 2020
Last update
Sep 26, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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