<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268980</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0481</org_study_id>
    <nct_id>NCT03268980</nct_id>
  </id_info>
  <brief_title>Smoking Prevalence at a University Hospital</brief_title>
  <acronym>TABAC-HCL</acronym>
  <official_title>Study of Smoking Prevalence at the &quot;Hospices Civils de Lyon&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Tobacco is the leading risk factor for avoidable mortality in France and around the&#xD;
           world. It is also the second cause of life with disability in the world and the leading&#xD;
           preventable risk factor for cancer in France and worldwide.&#xD;
&#xD;
        -  The &quot;Health Barometer&quot; studies carried out for 25 years in France by Santé-Publique&#xD;
           France assessed prevalence of smoking in the lay population. These studies showed that&#xD;
           smoking prevalence has stabilized among 15-75 year olds (34.1% of current smokers) with&#xD;
           a slight decrease in regular smoking (from 29.1% in 2010 to 28.2% in 2014).&#xD;
&#xD;
        -  Data on the prevalence of smoking among hospital staff are contradictory. Some studies&#xD;
           find a higher prevalence of active smoking than the general population; others have a&#xD;
           lower prevalence. However, it appears that an active prevention policy with hospital&#xD;
           staff can significantly and rapidly reduce the prevalence of active smoking.&#xD;
&#xD;
        -  The prevalence of active smoking in patients is logically higher than in the general&#xD;
           population (at comparable age).&#xD;
&#xD;
        -  The data on the prevalence of smoking among medical students are also contradictory.&#xD;
           Yet, this population is a special interest group given their future investment in&#xD;
           patient care.&#xD;
&#xD;
        -  Cannabis use also appears to be an independent risk factor for respiratory diseases and&#xD;
           broncho-pulmonary cancers. Cannabis use among health students is not uncommon (11.5% of&#xD;
           students). To our knowledge, the measurement of the prevalence of Cannabis use in an&#xD;
           all-patient population of a hospital-university facility has never been achieved.&#xD;
&#xD;
        -  According to the health barometer 2014, about a quarter of 15-75 year olds have already&#xD;
           tried electronic cigarettes and 6% are regular current users. Although the toxicity of&#xD;
           the electronic cigarette and its interest in weaning remain controversial, its use to&#xD;
           patients, staff or patients has been reported very little.&#xD;
&#xD;
      The aim of this study is to assess the impact of collective and individual tobacco control&#xD;
      measures by measuring the prevalence of smoking on a given day at the &quot;Hospices Civils de&#xD;
      Lyon&quot;, among patients, staff and students present on a given day.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2017</start_date>
  <completion_date type="Actual">November 23, 2017</completion_date>
  <primary_completion_date type="Actual">November 23, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>One day</time_frame>
    <description>The aim of this study is to determine the proportion of active smoker / smoker weaned / non-smoker in each group (patients / hospital staff / students).&#xD;
Data are collected by a questionnaire.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">11276</enrollment>
  <condition>Tobacco Smoking</condition>
  <arm_group>
    <arm_group_label>Patients group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hospital staff group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Students group</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Hospital Staff group</intervention_name>
    <description>One-page questionnaire with 15 questions about tobacco habits</description>
    <arm_group_label>Hospital staff group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire students and patients group</intervention_name>
    <description>One-page questionnaire with 17 questions about tobacco habits</description>
    <arm_group_label>Patients group</arm_group_label>
    <arm_group_label>Students group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Three populations are identified:&#xD;
&#xD;
          -  Patients group: All persons admitted to the Hospices Cvils de Lyon on the day of the&#xD;
             investigation, whatever the reason.&#xD;
&#xD;
          -  Hospital staff group: All members of the staff of the Hospices Civils de Lyon, present&#xD;
             at their place of work on the day of the inquiry, whatever their status.&#xD;
&#xD;
          -  Students group: All students of the faculties of medicine of Université Lyon I and of&#xD;
             the Hospices Civils de Lyon training institutes present in the university or training&#xD;
             institute on the day of the survey, whatever their status.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients group: Any person, over 18 years of age, hospitalized in one of the&#xD;
        establishments of the Hospices Civils de Lyon, whatever the reason and the duration.&#xD;
&#xD;
        - Hospital staff group: Anyone, whatever age and trade, paid directly by the Hospices&#xD;
        Civils de Lyon on the day of the survey, regardless of the duration of the employment&#xD;
        contract, and present on one of the sites of the Hospices Civils de Lyon the day of the&#xD;
        investigation.&#xD;
&#xD;
        - Students group: Everyone who is regularly enrolled in one of the schools or institutes of&#xD;
        the Hospices Civils de Lyon or in one of the two faculties of medicine of the Université&#xD;
        Lyon I, in any initial training and present on one of the sites of the faculties the day of&#xD;
        the investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients group:&#xD;
&#xD;
               -  Refusal to participate&#xD;
&#xD;
               -  Refusal of parents or legal representative for minors or adults of full age.&#xD;
&#xD;
               -  Child under the age of 18 at the time of the survey.&#xD;
&#xD;
               -  Individual who do not speak, understand or read the French language.&#xD;
&#xD;
               -  Non-hospitalized individuals (including external consultants).&#xD;
&#xD;
               -  Patient whose clinical status is not compatible with the administration of the&#xD;
                  questionnaire (eg, disorders of consciousness, severe cognitive impairment,&#xD;
                  severe speech disturbances, extreme asthenia) as judged by the service health&#xD;
                  framework and / or the medical team of the service.&#xD;
&#xD;
               -  Individual currently incarcerated.&#xD;
&#xD;
          -  Hospital staff group:&#xD;
&#xD;
               -  Refusal to participate.&#xD;
&#xD;
               -  Temporary staff (not paid directly by the Hospices Civils de Lyon on the day of&#xD;
                  the survey).&#xD;
&#xD;
               -  Students present on the day of the survey, and in particular: hospital students,&#xD;
                  nursing students and nursing assistants.&#xD;
&#xD;
          -  Students group:&#xD;
&#xD;
               -  Refusal to participate&#xD;
&#xD;
               -  Professional present in the school / institute / faculty as part of continuing&#xD;
                  education.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique - Hôpital Lyon-Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>June 8, 2018</last_update_submitted>
  <last_update_submitted_qc>June 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268980
org study id: 69HCL17_0481
nct id: NCT03268980
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
-  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.
observational model: Cohort
time perspective: Prospective
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
description: 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.
arm group label: Patients group
description: 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.
arm group label: Hospital staff group
description: 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.
arm group label: Students group
description: 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
intervention type: Other
intervention name: Questionnaire Hospital Staff group
description: One-page questionnaire with 15 questions about tobacco habits
arm group label: Hospital staff group
intervention type: Other
intervention name: Questionnaire students and patients group
description: One-page questionnaire with 17 questions about tobacco habits
arm group label: Patients group
arm group label: Students group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No