<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/NCT03798158</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02757-48</org_study_id>
    <nct_id>NCT03798158</nct_id>
  </id_info>
  <brief_title>Prevalence and Characterization of Persistent Dyspnea After Hospitalization</brief_title>
  <acronym>DyHP</acronym>
  <official_title>Prevalence and Characterization of Persistent Dyspnea After an Hospitalization for a Respiratory Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to make an overview of persistent dyspnea at the end of an&#xD;
      hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea&#xD;
      Profile questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease</measure>
    <time_frame>An average of one week, until the end of the hospitalization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterization of persistent dyspnea using MDP</measure>
    <time_frame>An average of one week, until the end of the hospitalization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome of patients with persistent dyspnea after hospitalization</measure>
    <time_frame>6 months</time_frame>
    <description>6 months mortality, incidence of rehospitalization</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Dyspnea</condition>
  <condition>Pulmonary Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidisciplinary Dyspnea Profile questionnaire</intervention_name>
    <description>Multidisciplinary Dyspnea Profile questionnaire at the beginning and the end of an hospitalization</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Every consecutive patient admitted to hospitalization for a respiratory cause having a&#xD;
        significant dyspnea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years old&#xD;
&#xD;
          -  Able to respond the questionnaire&#xD;
&#xD;
          -  Presenting at admission a dyspnea over 3/10 on numerical analogic scale&#xD;
&#xD;
          -  Admitted for a respiratory cause&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  aphasia&#xD;
&#xD;
          -  no french-speaking person&#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>ADOREPS</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Capucine MORELOT, MD,PhD</last_name>
      <phone>01 42 16 77 71</phone>
      <phone_ext>0033</phone_ext>
      <email>capucine.morelot@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</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/NCT03798158
org study id: 2018-A02757-48
nct id: NCT03798158
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators aim to make an overview of persistent dyspnea at the end of an
      hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea
      Profile questionnaire.
observational model: Other
time perspective: Prospective
measure: Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease
time frame: An average of one week, until the end of the hospitalization
measure: Characterization of persistent dyspnea using MDP
time frame: An average of one week, until the end of the hospitalization
measure: Outcome of patients with persistent dyspnea after hospitalization
time frame: 6 months
description: 6 months mortality, incidence of rehospitalization
intervention type: Other
intervention name: Multidisciplinary Dyspnea Profile questionnaire
description: Multidisciplinary Dyspnea Profile questionnaire at the beginning and the end of an hospitalization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Dyspnea