Tobacco SmokingTABAC-HCLNCT03268980
Smoking Prevalence at a University Hospital
An observational study of Tobacco Smoking, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Tobacco is the leading risk factor for avoidable mortality in France and around the world. It is also the second cause of life with disability in the world and the leading preventable risk factor for cancer in France and worldwide. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Questionnaire Hospital Staff group and Questionnaire students and patients group
- How many people
- 11,276 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2017to 23 Nov 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three populations are identified: * Patients group: All persons admitted to the Hospices Cvils de Lyon on the day of the investigation, whatever the reason. * Hospital staff group: All members of the staff of the Hospices Civils de Lyon, present at their place of work on the day of the inquiry, whatever their status. * Students group: All students of the faculties of medicine of Université Lyon I and of the Hospices Civils de Lyon training institutes present in the university or training institute on the day of the survey, whatever their status.
Who may be able to join
- Patients group: Any person, over 18 years of age, hospitalized in one of the establishments of the Hospices Civils de Lyon, whatever the reason and the duration.
- Hospital staff group: Anyone, whatever age and trade, paid directly by the Hospices Civils de Lyon on the day of the survey, regardless of the duration of the employment contract, and present on one of the sites of the Hospices Civils de Lyon the day of the investigation.
- Students group: Everyone who is regularly enrolled in one of the schools or institutes of the Hospices Civils de Lyon or in one of the two faculties of medicine of the Université Lyon I, in any initial training and present on one of the sites of the faculties the day of the investigation
Who cannot join
- Patients group:
- Refusal to participate
- Refusal of parents or legal representative for minors or adults of full age.
- Child under the age of 18 at the time of the survey.
- Individual who do not speak, understand or read the French language.
- Non-hospitalized individuals (including external consultants).
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- Patient whose clinical status is not compatible with the administration of the questionnaire (eg, disorders of consciousness, severe cognitive impairment, severe speech disturbances, extreme asthenia) as judged by the service health framework and / or the medical team of the service.
- Individual currently incarcerated.
- Hospital staff group:
- Refusal to participate.
- Temporary staff (not paid directly by the Hospices Civils de Lyon on the day of the survey).
- Students present on the day of the survey, and in particular: hospital students, nursing students and nursing assistants.
- Students group:
- Refusal to participate
- Professional present in the school / institute / faculty as part of continuing education.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique - Hôpital Lyon-Sud
Pierre-Bénite, 69495
About this study
Official title: Study of Smoking Prevalence at the "Hospices Civils de Lyon"
- Tobacco is the leading risk factor for avoidable mortality in France and around the world. It is also the second cause of life with disability in the world and the leading preventable risk factor for cancer in France and worldwide.
- The "Health Barometer" studies carried out for 25 years in France by Santé-Publique France assessed prevalence of smoking in the lay population. These studies showed that smoking prevalence has stabilized among 15-75 year olds (34.1% of current smokers) with a slight decrease in regular smoking (from 29.1% in 2010 to 28.2% in 2014).
- Data on the prevalence of smoking among hospital staff are contradictory. Some studies find a higher prevalence of active smoking than the general population; others have a lower prevalence. However, it appears that an active prevention policy with hospital staff can significantly and rapidly reduce the prevalence of active smoking.
- The prevalence of active smoking in patients is logically higher than in the general population (at comparable age).
- The data on the prevalence of smoking among medical students are also contradictory. Yet, this population is a special interest group given their future investment in patient care.
- Cannabis use also appears to be an independent risk factor for respiratory diseases and broncho-pulmonary cancers. Cannabis use among health students is not uncommon (11.5% of students). To our knowledge, the measurement of the prevalence of Cannabis use in an all-patient population of a hospital-university facility has never been achieved.
- According to the health barometer 2014, about a quarter of 15-75 year olds have already tried electronic cigarettes and 6% are regular current users. Although the toxicity of the electronic cigarette and its interest in weaning remain controversial, its use to patients, staff or patients has been reported very little.
The aim of this study is to assess the impact of collective and individual tobacco control measures by measuring the prevalence of smoking on a given day at the "Hospices Civils de Lyon", among patients, staff and students present on a given day.
- Conditions
- Tobacco Smoking
- Being tested
- Questionnaire Hospital Staff group, Questionnaire students and patients group
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire Hospital Staff groupOther
One-page questionnaire with 15 questions about tobacco habits
Questionnaire students and patients groupOther
One-page questionnaire with 17 questions about tobacco habits
| Study group | Role | What they receive |
|---|---|---|
| Patients group | All patients (over 18y) admitted to the Hospices Civils de Lyon the day of the study, whatever the reason, able to fullfill the questionnaire by themselves. Receives: Other: Questionnaire students and patients group | |
| Hospital staff group | Anyone, whatever age and trade, paid directly by the Hospices Civils de Lyon on the day of the survey, regardless of the duration of the employment contract, and present on one of the sites of the Hospices Civils de Lyon the day of the investigation. Receives: Other: Questionnaire Hospital Staff group | |
| Students group | Everyone who is regularly enrolled in one of the schools or institutes of the Hospices Civils de Lyon or in one of the two faculties of medicine of the Université Lyon I, in any initial training and present on one of the sites of the faculties the day of the investigation Receives: Other: Questionnaire students and patients group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the prevalence of smoking one day given to the Hospices Civils de Lyon, in patients, the members of the staff and students present one day
The aim of this study is to determine the proportion of active smoker / smoker weaned / non-smoker in each group (patients / hospital staff / students).
Data are collected by a questionnaire.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start23 Nov 2017
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies 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
- 11,276 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
- NCT03268980
- Sponsor's protocol ID
- 69HCL17_0481
- Acronym
- TABAC-HCL
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 11 Jun 2018
- 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 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Smoking Prevalence at the "Hospices Civils de Lyon"
- ClinicalTrials.gov ID
- NCT03268980
- Acronym / sponsor ID
- TABAC-HCL / 69HCL17_0481
- Conditions
- Tobacco Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,276 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 31 Aug 2017 (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.
- Tobacco is the leading risk factor for avoidable mortality in France and around the world. It is also the second cause of life with disability in the world and the leading preventable risk factor for cancer in France and worldwide.
- The "Health Barometer" studies carried out for 25 years in France by Santé-Publique France assessed prevalence of smoking in the lay population. These studies showed that smoking prevalence has stabilized among 15-75 year olds (34.1% of current smokers) with a slight decrease in regular smoking (from 29.1% in 2010 to 28.2% in 2014).
- Data on the prevalence of smoking among hospital staff are contradictory. Some studies find a higher prevalence of active smoking than the general population; others have a lower prevalence. However, it appears that an active prevention policy with hospital staff can significantly and rapidly reduce the prevalence of active smoking.
- The prevalence of active smoking in patients is logically higher than in the general population (at comparable age).
- The data on the prevalence of smoking among medical students are also contradictory. Yet, this population is a special interest group given their future investment in patient care.
- Cannabis use also appears to be an independent risk factor for respiratory diseases and broncho-pulmonary cancers. Cannabis use among health students is not uncommon (11.5% of students). To our knowledge, the measurement of the prevalence of Cannabis use in an all-patient population of a hospital-university facility has never been achieved.
- According to the health barometer 2014, about a quarter of 15-75 year olds have already tried electronic cigarettes and 6% are regular current users. Although the toxicity of the electronic cigarette and its interest in weaning remain controversial, its use to patients, staff or patients has been reported very little.
The aim of this study is to assess the impact of collective and individual tobacco control measures by measuring the prevalence of smoking on a given day at the "Hospices Civils de Lyon", among patients, staff and students present on a given day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: Questionnaire students and patients groupAll patients (over 18y) admitted to the Hospices Civils de Lyon the day of the study, whatever the reason, able to fullfill the questionnaire by themselves. |
| Hospital staff group | – | Other: Questionnaire Hospital Staff groupAnyone, whatever age and trade, paid directly by the Hospices Civils de Lyon on the day of the survey, regardless of the duration of the employment contract, and present on one of the sites of the Hospices Civils de Lyon the day of the investigation. |
| Students group | – | Other: Questionnaire students and patients groupEveryone who is regularly enrolled in one of the schools or institutes of the Hospices Civils de Lyon or in one of the two faculties of medicine of the Université Lyon I, in any initial training and present on one of the sites of the faculties the day of the investigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three populations are identified: * Patients group: All persons admitted to the Hospices Cvils de Lyon on the day of the investigation, whatever the reason. * Hospital staff group: All members of the staff of the Hospices Civils de Lyon, present at their place of work on the day of the inquiry, whatever their status. * Students group: All students of the faculties of medicine of Université Lyon I and of the Hospices Civils de Lyon training institutes present in the university or training institute on the day of the survey, whatever their status.
Key inclusion criteria (3 listed)
- Patients group: Any person, over 18 years of age, hospitalized in one of the establishments of the Hospices Civils de Lyon, whatever the reason and the duration.
- Hospital staff group: Anyone, whatever age and trade, paid directly by the Hospices Civils de Lyon on the day of the survey, regardless of the duration of the employment contract, and present on one of the sites of the Hospices Civils de Lyon the day of the investigation.
- Students group: Everyone who is regularly enrolled in one of the schools or institutes of the Hospices Civils de Lyon or in one of the two faculties of medicine of the Université Lyon I, in any initial training and present on one of the sites of the faculties the day of the investigation
Key exclusion criteria (15 listed)
- Patients group:
- Hospital staff group:
- Students group:
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 |
|---|---|---|
| Questionnaire Hospital Staff groupOne-page questionnaire with 15 questions about tobacco habits | Other | Hospital staff group |
| Questionnaire students and patients groupOne-page questionnaire with 17 questions about tobacco habits | Other | Patients group, Students group |
Primary outcome
Measure the prevalence of smoking one day given to the Hospices Civils de Lyon, in patients, the members of the staff and students present one day
Time frame: One day
The aim of this study is to determine the proportion of active smoker / smoker weaned / non-smoker in each group (patients / hospital staff / students). Data are collected by a 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 11 Jun 2018.
- 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 Tobacco Smoking, 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 3 inclusion and 15 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 11 Jun 2018. 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?
Measure the prevalence of smoking one day given to the Hospices Civils de Lyon, in patients, the members of the staff and students present one day (time frame: One day). 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 11 Jun 2018.