<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/NCT04459143</url>
  </required_header>
  <id_info>
    <org_study_id>CHRD 0918</org_study_id>
    <nct_id>NCT04459143</nct_id>
  </id_info>
  <brief_title>Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives</brief_title>
  <acronym>DIABPCO</acronym>
  <official_title>Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital NOVO</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital NOVO</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>
      The aim of this study is to evaluate if the participation of COPD patients to a workshop on&#xD;
      advance directives increases the number of patients who write them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Disease is a common disease and should be the third leading cause of&#xD;
      death in 2020. Patient hospitalized for an exacerbation of their COPD have a median survival&#xD;
      of 2 years and 50% risk of being rehospitalized within 6 months.&#xD;
&#xD;
      COPD patients may have symptoms that impair their life quality significantly and sometimes&#xD;
      more than patients with cancer. This is particularly the case for dyspnea, which is&#xD;
      frequently present.&#xD;
&#xD;
      In the study, Investigators propose the setting up of health workshop on advance directives.&#xD;
      This workshop is for sever or very severe COPD patients during their hospital stay in the&#xD;
      post-acute care and pulmonary rehabilitation service.&#xD;
&#xD;
      In this unit, investigators welcome patient from all the region of Ile de France for a&#xD;
      hospital stay of approximately 6 weeks. A first workshop will take place during the third&#xD;
      week of their care to inform them about COPD, exacerbations, prognostic and advance&#xD;
      directives. Then, a personal interview with patients who have participated to this workshop&#xD;
      will take place to collect their advance directives and their degree of satisfaction about&#xD;
      this process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>Number of patient who write their advance directives</measure>
    <time_frame>At the end of patient hospital stay, approximately 6 weeks</time_frame>
    <description>The Primary Outcome Measure is the collect of the number of patients who write their advance directives after their participation of the health workshop</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of patient's satisfaction</measure>
    <time_frame>At the end of patient hospital stay, approximately 6 weeks</time_frame>
    <description>The satisfaction of patient was measured with a satisfaction questionnaire scale based on their feelings about the workshop. For each item, patient ticks : Strongly agree, Agree, Neither agree or disagree, Disagree or Strongly disagree</description>
  </secondary_outcome>
  <enrollment type="Actual">525</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Advance directives</intervention_name>
    <description>A workshop will take place during the third week of patient care to inform them about COPD, exacerbations, prognostic and advance directives. Then, a personal interview with patients who have participated to this workshop will take place at the end of their hospital stay, to collect their advance directives and their degree of satisfaction about this process.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with COPD Gold 3 or 4 who accept to participate to the workshop&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD Gold 3 or 4 and Curtis criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  left to the discretion of the investigator if he finds that it will not be beneficial&#xD;
             for the patient : for example if the workshop is judged to be at risk of being&#xD;
             anxiety-provoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-François Boitiaux</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital NOVO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire</name>
      <address>
        <city>Aincourt</city>
        <zip>95510</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Palliative care</keyword>
  <keyword>Advance directives</keyword>
  <keyword>Exacerbation</keyword>
  <keyword>Dyspnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT04459143
org study id: CHRD 0918
nct id: NCT04459143
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate if the participation of COPD patients to a workshop on
      advance directives increases the number of patients who write them.
Chronic Obstructive Disease is a common disease and should be the third leading cause of
      death in 2020. Patient hospitalized for an exacerbation of their COPD have a median survival
      of 2 years and 50% risk of being rehospitalized within 6 months.

      COPD patients may have symptoms that impair their life quality significantly and sometimes
      more than patients with cancer. This is particularly the case for dyspnea, which is
      frequently present.

      In the study, Investigators propose the setting up of health workshop on advance directives.
      This workshop is for sever or very severe COPD patients during their hospital stay in the
      post-acute care and pulmonary rehabilitation service.

      In this unit, investigators welcome patient from all the region of Ile de France for a
      hospital stay of approximately 6 weeks. A first workshop will take place during the third
      week of their care to inform them about COPD, exacerbations, prognostic and advance
      directives. Then, a personal interview with patients who have participated to this workshop
      will take place to collect their advance directives and their degree of satisfaction about
      this process.
observational model: Cohort
time perspective: Prospective
measure: Number of patient who write their advance directives
time frame: At the end of patient hospital stay, approximately 6 weeks
description: The Primary Outcome Measure is the collect of the number of patients who write their advance directives after their participation of the health workshop
measure: Measure of patient's satisfaction
time frame: At the end of patient hospital stay, approximately 6 weeks
description: The satisfaction of patient was measured with a satisfaction questionnaire scale based on their feelings about the workshop. For each item, patient ticks : Strongly agree, Agree, Neither agree or disagree, Disagree or Strongly disagree
intervention type: Behavioral
intervention name: Advance directives
description: A workshop will take place during the third week of patient care to inform them about COPD, exacerbations, prognostic and advance directives. Then, a personal interview with patients who have participated to this workshop will take place at the end of their hospital stay, to collect their advance directives and their degree of satisfaction about this process.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-François Boitiaux
role: Principal Investigator
affiliation: Hôpital NOVO
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive