<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/NCT03281642</url>
  </required_header>
  <id_info>
    <org_study_id>HAO16020</org_study_id>
    <nct_id>NCT03281642</nct_id>
  </id_info>
  <brief_title>Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients</brief_title>
  <acronym>HOT</acronym>
  <official_title>Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 consumption is a major public health problem, ranking second in the leading cause of&#xD;
      morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized&#xD;
      patients is evaluated around 20% and the management of tobacco reduction/cessation is an&#xD;
      major issue for the course and outcome of many disorders.&#xD;
&#xD;
      Recent recommendations published by the French National Health Authority (&quot;Haute Autorité de&#xD;
      Santé&quot;, HAS) call for the involvement of all health professionals in helping patients to stop&#xD;
      smoking and hospitalized patients are identified as a specific target. In addition, the&#xD;
      meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco&#xD;
      cessation) were those that include all patients, starting during the hospitalization with a&#xD;
      specific follow-up of at least one month, and with the addition of nicotine replacement&#xD;
      therapy. This combination increased the odds of successful tobacco cessation by 54%.&#xD;
&#xD;
      The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on&#xD;
      tobacco smoking consumption in a population of hospitalized patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>1 month tobacco smoking prevalence</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>6 month tobacco smoking prevalence</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">430</enrollment>
  <condition>Smoking Patients</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tobacco management</intervention_name>
    <description>Training of healthcare teams for tobacco management by trained nurses. The intervention will consist of 3 minimum interviews, about 30 minutes each.</description>
    <other_name>Training of healthcare teams for tobacco management</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All smoking patients hospitalized in one of the participating unit of the&#xD;
        Saint-Louis-Lariboisière-Fernand Widal hospital (Diabetology, Cardiology, adults and&#xD;
        adolescents Onco-hématology, Orthopedy, Oncology, Internal Medecine, Pneumology,&#xD;
        Dermatology, Rhumatology, Psychiatry, Gastro-Entérology, Neurology) during the study period&#xD;
        that include the 6 months preceding and the 6 months following the training.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient (&gt;= 18 years), tobacco smokers, hospitalized in one of the participating&#xD;
             unit during the inclusion period.&#xD;
&#xD;
          -  For the sake of coherence with the literature, only subjects who smoked at least one&#xD;
             cigarette a day in the previous 30 days before the hospitalization will be considered&#xD;
             as &quot;smokers&quot;.&#xD;
&#xD;
          -  Affiliated to the national health system&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients enrolled in an addiction treatment during their hospitalization stay&#xD;
&#xD;
          -  Cognitive deficit that makes the informed consent and the telephone interview&#xD;
             impossible&#xD;
&#xD;
          -  Aphasia&#xD;
&#xD;
          -  Patient who does not speak French&#xD;
&#xD;
          -  Life expectancy below 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fernand Widal hospital</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03281642
org study id: HAO16020
nct id: NCT03281642
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Tobacco consumption is a major public health problem, ranking second in the leading cause of
      morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized
      patients is evaluated around 20% and the management of tobacco reduction/cessation is an
      major issue for the course and outcome of many disorders.

      Recent recommendations published by the French National Health Authority ("Haute Autorité de
      Santé", HAS) call for the involvement of all health professionals in helping patients to stop
      smoking and hospitalized patients are identified as a specific target. In addition, the
      meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco
      cessation) were those that include all patients, starting during the hospitalization with a
      specific follow-up of at least one month, and with the addition of nicotine replacement
      therapy. This combination increased the odds of successful tobacco cessation by 54%.

      The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on
      tobacco smoking consumption in a population of hospitalized patients.
observational model: Other
time perspective: Other
measure: 1 month tobacco smoking prevalence
time frame: 1 month
measure: 6 month tobacco smoking prevalence
time frame: 6 months
intervention type: Other
intervention name: Tobacco management
description: Training of healthcare teams for tobacco management by trained nurses. The intervention will consist of 3 minimum interviews, about 30 minutes each.
other name: Training of healthcare teams for tobacco management
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided