Unhealthy Alcohol UseDECORANCT04329988
Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.
An observational study of Unhealthy Alcohol Use, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unhealthy Alcohol Use
- What is being tested?
- questionnaire
- How many people
- 394 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2020to 18 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population consulting in a primary care office over 18 years old.
Who may be able to join
- Consulting in a general practitioner's office
- Over 18 years Old
Who cannot join
- Less than 18 years old
- Pregnant women or breast-feeding mothers
- People under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Cabinet de Médecine Générale Dr Christine Maynie-François
Saint-Quentin-Fallavier, 38070
About this study
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.
- Conditions
- Unhealthy Alcohol Use
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary care patients aged 18 or more | All patients consulting in a general practitioner office, aged 18 or more, who completed the questionnaire Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).
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
Measured: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start28 May 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unhealthy Alcohol UseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329988
- Sponsor's protocol ID
- 69HCL19_0889
- Acronym
- DECORA
- Status last verified
- Jan 2021
- First submitted
- 30 Mar 2020
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.
- ClinicalTrials.gov ID
- NCT04329988
- Acronym / sponsor ID
- DECORA / 69HCL19_0889
- Conditions
- Unhealthy Alcohol Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care patients aged 18 or more | – | Other: questionnaireAll patients consulting in a general practitioner office, aged 18 or more, who completed the questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population consulting in a primary care office over 18 years old.
Key inclusion criteria (2 listed)
- Consulting in a general practitioner's office
- Over 18 years Old
Key exclusion criteria (3 listed)
- Less than 18 years old
- Pregnant women or breast-feeding mothers
- People under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireA 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. | Other | Primary care patients aged 18 or more |
Primary outcome
sensitivity of the single question
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unhealthy Alcohol Use, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of the single question (time frame: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.