<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/NCT03235401</url>
  </required_header>
  <id_info>
    <org_study_id>PAH-DBoQ</org_study_id>
    <nct_id>NCT03235401</nct_id>
  </id_info>
  <brief_title>The PAH Disability and Bothersomeness Questionnaire</brief_title>
  <acronym>PAH-DBoQ</acronym>
  <official_title>&quot;Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association de Recherche en Physiopathologie Respiratoire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Soladis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Interlis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association de Recherche en Physiopathologie Respiratoire</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>
      To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary&#xD;
      arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure&#xD;
      (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus&#xD;
      study) leading to the development of a provisional 37-items questionnaire. A reduction of&#xD;
      items in this provisional questionnaire and the validation of the final questionnaire are the&#xD;
      goals of the current study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 16, 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 16, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cronbach's alpha≥ 0.7</measure>
    <time_frame>at the end of the study (an average of 6 months)</time_frame>
    <description>Internal consistency of the PAH Disability and Bothersomeness Questionnaire will be assessed with Cronhbach's alpha</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low rate of answers (≤95%)</measure>
    <time_frame>at the end of the study (an average of 6 months)</time_frame>
    <description>low rate of answers will help reducing the number of questionnaire's items</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pulmonary Arterial Hypertension (PAH)</condition>
  <arm_group>
    <arm_group_label>Pulmonary Arterial Hypertension patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>37-items questionnaire</intervention_name>
    <description>Patient will answer the PAH-DBoQ questionnaire</description>
    <arm_group_label>Pulmonary Arterial Hypertension patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  120 patients with idiopathic and heritable PAH (40 of which will be selected for a&#xD;
             test-retest procedure)&#xD;
&#xD;
          -  Patients with PAH associated with other diseases will be excluded in order to clearly&#xD;
             circumscribe the results to PAH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with idiopathic and heritable PAH;&#xD;
&#xD;
          -  patients over 18;&#xD;
&#xD;
          -  male and female;&#xD;
&#xD;
          -  NYHA Functional Class I, II, III &amp; IV;&#xD;
&#xD;
          -  Written consent signed&#xD;
&#xD;
          -  Patients with a good understanding of the French - language&#xD;
&#xD;
          -  Patient affiliated with a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age&#xD;
&#xD;
          -  Patients with other pathologies associated with PAH (Group 1)&#xD;
&#xD;
          -  Patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5)&#xD;
&#xD;
          -  Non-consenting patients&#xD;
&#xD;
          -  Patients who do not have a good understanding of the French language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Olivier SITBON, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olivier SITBON, PHD</last_name>
    <phone>145217972</phone>
    <phone_ext>+33</phone_ext>
    <email>olivier.sitbon@u-psud.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <state>Val De Marne</state>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier SITBON, PHD</last_name>
      <phone>+33-(0)1 45 21 79 72</phone>
      <email>olivier.sitbon@u-psud.fr</email>
    </contact>
    <contact_backup>
      <last_name>Sophie ALAMI, PHD</last_name>
      <phone>00 33 68 50 64 857</phone>
      <email>interlis.france@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Questionnaire</keyword>
  <keyword>Disability assessment</keyword>
  <keyword>Bothersomeness</keyword>
  <keyword>Pulmonary Arterial Hypertension</keyword>
  <keyword>patient-reported outcome measure</keyword>
  <keyword>New York Heart Association (NYHA) functional class</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <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/NCT03235401
org study id: PAH-DBoQ
nct id: NCT03235401
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary
      arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.
A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure
      (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus
      study) leading to the development of a provisional 37-items questionnaire. A reduction of
      items in this provisional questionnaire and the validation of the final questionnaire are the
      goals of the current study.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Cronbach's alpha≥ 0.7
time frame: at the end of the study (an average of 6 months)
description: Internal consistency of the PAH Disability and Bothersomeness Questionnaire will be assessed with Cronhbach's alpha
measure: Low rate of answers (≤95%)
time frame: at the end of the study (an average of 6 months)
description: low rate of answers will help reducing the number of questionnaire's items
arm group label: Pulmonary Arterial Hypertension patients
intervention type: Other
intervention name: 37-items questionnaire
description: Patient will answer the PAH-DBoQ questionnaire
arm group label: Pulmonary Arterial Hypertension patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Olivier SITBON, PHD
role: Principal Investigator
affiliation: Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France
last name: Olivier SITBON, PHD
phone: 145217972
phone ext: +33
email: olivier.sitbon@u-psud.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
sharing ipd: No