<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/NCT02229994</url>
  </required_header>
  <id_info>
    <org_study_id>2009-A00181-56</org_study_id>
    <nct_id>NCT02229994</nct_id>
  </id_info>
  <brief_title>Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases</brief_title>
  <acronym>DYSLIM</acronym>
  <official_title>Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is the psychometric validation of a self-administered dyspnea&#xD;
      questionnaire, usable in clinical practice in order to assess dyspnea and its impact on&#xD;
      patients with chronic respiratory diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dyspnea is a cardinal Respiratory symptom.&#xD;
&#xD;
      According to the ATS dyspnea is the term used to characterize a subjective experience of&#xD;
      breathing discomfort, covering qualitatively distinct sensations of varying intensity.&#xD;
&#xD;
      The subjective nature of dyspnea and the high complexity of its determinants explain the&#xD;
      often moderate correlations obtained with physiological data. Dyspnea must therefore be&#xD;
      measured specifically.&#xD;
&#xD;
      The aim of this study is the cross-sectional and longitudinal psychometric validation of a&#xD;
      self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities&#xD;
      restriction), usable in clinical practice in order to assess dyspnea and its alterations in&#xD;
      adult patients with chronic respiratory diseases.&#xD;
&#xD;
      (COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)&#xD;
&#xD;
      Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally&#xD;
      satisfy all the following required features: evaluative, discriminant, good reproducibility,&#xD;
      and high sensitivity to change.&#xD;
&#xD;
      The desired features apart from content validity are reproducibility and especially a high&#xD;
      sensitivity to change, particularly following pulmonary rehabilitation.&#xD;
&#xD;
      Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and&#xD;
      it's sustainment in maintenance phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2010</start_date>
  <completion_date type="Actual">December 30, 2015</completion_date>
  <primary_completion_date type="Actual">March 27, 2014</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>Psychometric validity of the questionnaire</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of responses distribution</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structural analysis (in principal components)</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>External and convergent validity</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Internal coherence</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility</measure>
    <time_frame>7 days</time_frame>
    <description>for a sub sample of 50 patients, Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminating properties</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derivation of a scoring algorithm</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity to change</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Sensitivity to change will be analyzed in relation to:&#xD;
The TDI score, at the Likert scale on changes in dyspnea The scores of quality of life with their respective significant thresholds A the overall medical evaluation A changing EFR parameters with their respective significant thresholds (FEV, DLCO, walk test .....).&#xD;
All this are the transversal data necessaries to assess the validation of a psychometric self-administered dyspnea questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal difference clinically relevant</measure>
    <time_frame>Until end of treatment (making a total of 6 months)</time_frame>
    <description>Cross-sectional data necessary to assess the psychometric validity of a self-administered dyspnea questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">199</enrollment>
  <condition>COPD (With - Without Rehabilitation)</condition>
  <condition>Diffuse Interstitial Lung Diseases</condition>
  <condition>Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....)</condition>
  <condition>Cystic Fibrosis of the Adult</condition>
  <arm_group>
    <arm_group_label>Adults patients with chronic respiratory diseases</arm_group_label>
    <description>- 200 adult patients with chronic respiratory diseases will be studied longitudinally and transversely (follow-up: 6 months) in 12 centres.&#xD;
Sample 1 (n=110 patients) with COPD&#xD;
Sample 2 (n=30 patients) with Diffuse interstitial lung diseases&#xD;
Sample 3 (n=30 patients) with Pulmonary Arterial Hypertension primary or secondary (post embolic .....).&#xD;
Sample 4 (n=30 patients) Adult with Cystic fibrosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.</intervention_name>
    <description>Evaluation will be performed on a group of 200 patients deriving from 4 samples.&#xD;
From these 200 patients, a sub-sample will be evaluated at 7 days (DYSLIM questionnaire only) for reproducibility (n = 50 patients: 10 patients with diffuse interstitial lung disease, 10 patients with cystic fibrosis, 10 patients with arterial pulmonary hypertension, 20 patients with COPD).&#xD;
From these 200 patients, a sub-sample (COPD, n = 60) will be recruited among patients undergoing pulmonary rehabilitation at the beginning of the 6 months separating follow up visit and the initial assessment.</description>
    <arm_group_label>Adults patients with chronic respiratory diseases</arm_group_label>
    <other_name>Self-administered dyspnea questionnaire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study Population are adults patients with chronic respiratory diseases (Sample1: COPD;&#xD;
        Sample 2: Diffuse interstitial lung diseases; Sample 3: Pulmonary Arterial Hypertension&#xD;
        primary or secondary (post embolic .....); Sample 4: Adult with Cystic fibrosis)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Sample1: COPD GOLD / ATS &gt; 2 without major co-morbidity&#xD;
&#xD;
               -  Sample 1A: n = 50: group of patients with no change in usual care and no acute&#xD;
                  event (evaluation of reproducibility)&#xD;
&#xD;
               -  Sample1B: n = 60: patients assessed before and after a qualifying period of&#xD;
                  pulmonary rehabilitation&#xD;
&#xD;
          -  2) Sample 2 (n = 30): diffuse interstitial lung diseases Criteria: Pulmonary Fibrosis:&#xD;
             Idiopathic or nonspecific interstitial lung diseases (NILD) according to international&#xD;
             criteria (ATS), sarcoidosis with parenchymal lesions (old classification stage II and&#xD;
             III), and exceptionally alveolar proteinosis.&#xD;
&#xD;
          -  3) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post&#xD;
             embolic .....).&#xD;
&#xD;
          -  4) Sample4 (n = 30): Adult with Cystic fibrosis.&#xD;
&#xD;
          -  5) patient with stable Status (no exacerbation for at least one month)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Patient under 18 years&#xD;
&#xD;
          -  2) Inability to fill in questionnaires&#xD;
&#xD;
          -  3) Other respiratory disease&#xD;
&#xD;
          -  4) left symptomatic heart failure&#xD;
&#xD;
          -  5) Obesity with a BMI&gt; 35 kg/m2&#xD;
&#xD;
          -  6) Inability to perform PFT (Pulmonary Function Testing)&#xD;
&#xD;
          -  7) Pregnant or breastfeeding woman&#xD;
&#xD;
          -  8) Patient unable to consent&#xD;
&#xD;
          -  9) Lack of social insurance coverage&#xD;
&#xD;
          -  10) Patient in exclusion period because of another protocol&#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>Thierry Perez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHRU de Lille / Hôpital Calmette - France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolas ROCHE, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP- Hopital Cochin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre</name>
      <address>
        <city>Paris</city>
        <zip>75006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 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>Dyspnea</keyword>
  <keyword>Self-administered questionnaire</keyword>
  <keyword>Chronic respiratory disease</keyword>
  <keyword>COPD</keyword>
  <keyword>Diffuse interstitial lung diseases</keyword>
  <keyword>Pulmonary arterial hypertension</keyword>
  <keyword>Cystic fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Fibrosis</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/NCT02229994
org study id: 2009-A00181-56
nct id: NCT02229994
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is the psychometric validation of a self-administered dyspnea
      questionnaire, usable in clinical practice in order to assess dyspnea and its impact on
      patients with chronic respiratory diseases.
Dyspnea is a cardinal Respiratory symptom.

      According to the ATS dyspnea is the term used to characterize a subjective experience of
      breathing discomfort, covering qualitatively distinct sensations of varying intensity.

      The subjective nature of dyspnea and the high complexity of its determinants explain the
      often moderate correlations obtained with physiological data. Dyspnea must therefore be
      measured specifically.

      The aim of this study is the cross-sectional and longitudinal psychometric validation of a
      self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities
      restriction), usable in clinical practice in order to assess dyspnea and its alterations in
      adult patients with chronic respiratory diseases.

      (COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)

      Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally
      satisfy all the following required features: evaluative, discriminant, good reproducibility,
      and high sensitivity to change.

      The desired features apart from content validity are reproducibility and especially a high
      sensitivity to change, particularly following pulmonary rehabilitation.

      Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and
      it's sustainment in maintenance phase.
observational model: Cohort
time perspective: Prospective
measure: Psychometric validity of the questionnaire
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire
measure: Analysis of responses distribution
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: Structural analysis (in principal components)
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: External and convergent validity
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: Internal coherence
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: Reproducibility
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: Reproducibility
time frame: 7 days
description: for a sub sample of 50 patients, Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: Discriminating properties
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: Derivation of a scoring algorithm
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
measure: Sensitivity to change
time frame: Until end of treatment (making a total of 6 months)
description: Sensitivity to change will be analyzed in relation to:
The TDI score, at the Likert scale on changes in dyspnea The scores of quality of life with their respective significant thresholds A the overall medical evaluation A changing EFR parameters with their respective significant thresholds (FEV, DLCO, walk test .....).
All this are the transversal data necessaries to assess the validation of a psychometric self-administered dyspnea questionnaire.
measure: Minimal difference clinically relevant
time frame: Until end of treatment (making a total of 6 months)
description: Cross-sectional data necessary to assess the psychometric validity of a self-administered dyspnea questionnaire
arm group label: Adults patients with chronic respiratory diseases
description: - 200 adult patients with chronic respiratory diseases will be studied longitudinally and transversely (follow-up: 6 months) in 12 centres.
Sample 1 (n=110 patients) with COPD
Sample 2 (n=30 patients) with Diffuse interstitial lung diseases
Sample 3 (n=30 patients) with Pulmonary Arterial Hypertension primary or secondary (post embolic .....).
Sample 4 (n=30 patients) Adult with Cystic fibrosis
intervention type: Other
intervention name: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.
description: Evaluation will be performed on a group of 200 patients deriving from 4 samples.
From these 200 patients, a sub-sample will be evaluated at 7 days (DYSLIM questionnaire only) for reproducibility (n = 50 patients: 10 patients with diffuse interstitial lung disease, 10 patients with cystic fibrosis, 10 patients with arterial pulmonary hypertension, 20 patients with COPD).
From these 200 patients, a sub-sample (COPD, n = 60) will be recruited among patients undergoing pulmonary rehabilitation at the beginning of the 6 months separating follow up visit and the initial assessment.
arm group label: Adults patients with chronic respiratory diseases
other name: Self-administered dyspnea questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thierry Perez, MD
role: Study Chair
affiliation: CHRU de Lille / Hôpital Calmette - France
last name: Nicolas ROCHE, MD, PhD
role: Principal Investigator
affiliation: APHP- Hopital Cochin
facility: 
country: France
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Lung Diseases
mesh term: Pulmonary Arterial Hypertension
mesh term: Dyspnea
mesh term: Lung Diseases, Interstitial
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Hypertension
mesh term: Fibrosis