<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/NCT03810482</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0186</org_study_id>
    <nct_id>NCT03810482</nct_id>
  </id_info>
  <brief_title>Pedometers and Walking Tests for Pulmonary Hypertension Patients</brief_title>
  <acronym>HTAPODO</acronym>
  <official_title>Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Concordance between walking tests and pedometer data may seem like a logical outcome for&#xD;
      pulmonary hypertension (PH) patients. However, many individuals have discordant results:&#xD;
      results much worse or better during an in-hospital walking test as compared to real life&#xD;
      activity.&#xD;
&#xD;
      The primary objective of this study is: to determine variables associated with discordance&#xD;
      between the distance walked during an in-hospital 6-minute walking test (6MWT) and the&#xD;
      average distance travelled per day (observed over a period of 28 days (2 × 14 days) using a&#xD;
      pedometer) among PH patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondarily, the discordance between 6MWT results versus total pedometer recorded distance&#xD;
      and versus maximum daily pedometer-recorded distance will be similarly studied. The aim of&#xD;
      the study is also to search for variables associated with progression free survival. The&#xD;
      relationships between pedometer data and self-reported dyspnea variation will be studied.&#xD;
      Factorial analysis may be used to study the overall view of variable correlations and patient&#xD;
      similarity/dissimilarity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 21, 2019</start_date>
  <completion_date type="Anticipated">June 21, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 21, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>In this first study, the links between variables and discordance between walking test and pedometer results will be searched.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The patient's discordance category as precisely defined here:</measure>
    <time_frame>74 days</time_frame>
    <description>Linear regression is performed for the distance walked during an initial 6 minute walking test (6MWT) and the average distance walked per day according to the pedometer intervention. The residuals from this regression will determine categories:&#xD;
Category 1 (pedometer high): the 25% of subjects not in category 2 and with higher values for pedometer data&#xD;
Category 2 (concordance): the 50% of included subjects with the smallest residuals in terms of absolute value.&#xD;
Category 3 (6MWT high): the 25% of subjects not in category 2 and with higher values for 6MWT data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))</measure>
    <time_frame>Day 0</time_frame>
    <description>This scale evaluates social, emotional and physical health of the patient through 11 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))</measure>
    <time_frame>Month 3</time_frame>
    <description>This scale evaluates social, emotional and physical health of the patient through 11 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression (HAD) scale</measure>
    <time_frame>Day 0</time_frame>
    <description>It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression (HAD) scale</measure>
    <time_frame>Month 3</time_frame>
    <description>It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI) questionnaire</measure>
    <time_frame>Day 0</time_frame>
    <description>The State-Trait Anxiety Inventory is a 20 question-scale. For each question 4 levels of response are possible from 1 (never) to 4 (always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI) questionnaire</measure>
    <time_frame>Month 3</time_frame>
    <description>The State-Trait Anxiety Inventory is a 20 question-scale. For each question 4 levels of response are possible from 1 (never) to 4 (always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Fatigue Inventory (MFI)-20 questionnaire</measure>
    <time_frame>Day 0</time_frame>
    <description>This questionnaire assesses the severity of the patient fatigue through 20 questions. For each question, 4 levels of response are possible : from &quot;not at all&quot; to &quot;completely&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Fatigue Inventory (MFI)-20 questionnaire</measure>
    <time_frame>Month 3</time_frame>
    <description>This questionnaire assesses the severity of the patient fatigue through 20 questions. For each question, 4 levels of response are possible : from &quot;not at all&quot; to &quot;completely&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping with Health Injuries and Problems Scale</measure>
    <time_frame>Day 0</time_frame>
    <description>This questionnaire assesses how the patient responds to health injuries and problems with 32 questions. For each question 5 levels of response are possible from 1 (not at all) to 5 (always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping with Health Injuries and Problems Scale</measure>
    <time_frame>Month 3</time_frame>
    <description>This questionnaire assesses how the patient responds to health injuries and problems with 32 questions. For each question 5 levels of response are possible from 1 (not at all) to 5 (always).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <arm_group>
    <arm_group_label>The study population</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study population as described by eligibility criteria.&#xD;
Intervention: 6 minute walking test Intervention: pedometer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pedometer</intervention_name>
    <description>A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.</description>
    <arm_group_label>The study population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>6 minute walking test</intervention_name>
    <description>Performed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study).</description>
    <arm_group_label>The study population</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with idiopathic pulmonary hypertension (PH), familial PH, or PH associated&#xD;
             with various pathologies (groups I to IV of the international classification)&#xD;
&#xD;
          -  New York Heart Association (NYHA) severity classes II to IV&#xD;
&#xD;
          -  Incident cases, or prevalent cases with stable disease over the last 3 months&#xD;
&#xD;
          -  Collection of informed written consent&#xD;
&#xD;
          -  Affiliation with or beneficiary of a social security program (health insurance)&#xD;
&#xD;
          -  Outpatient consulting at the hospital on the day of inclusion&#xD;
&#xD;
          -  6 minute walking test on day of inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients protected or unable to give consent according to Article L1121-8 of the&#xD;
             French Public Health Code (CSP)&#xD;
&#xD;
          -  Pregnant or lactating women according to article L1121-5 of the CSP&#xD;
&#xD;
          -  Vulnerable persons according to article L1121-6 of the CSP&#xD;
&#xD;
          -  Simultaneous participation in any other research protocol&#xD;
&#xD;
          -  It is impossible to correctly inform the patient (language barrier, etc.)&#xD;
&#xD;
          -  The patient has already been included in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnaud Bourdin, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospitals of Monpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurence Halimi, PhD, psychologist</last_name>
    <phone>+33.(0)4.67.33.07.45</phone>
    <email>l-halimi@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Arnaud de Villeneuve Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Arnaud Bourdin, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Clement Boissin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne Sophie Gamez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Romain Jean, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jérémy Charriot, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>health related quality of life</keyword>
  <keyword>anxiety</keyword>
  <keyword>depression</keyword>
  <keyword>coping</keyword>
  <keyword>fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</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/NCT03810482
org study id: RECHMPL18_0186
nct id: NCT03810482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Concordance between walking tests and pedometer data may seem like a logical outcome for
      pulmonary hypertension (PH) patients. However, many individuals have discordant results:
      results much worse or better during an in-hospital walking test as compared to real life
      activity.

      The primary objective of this study is: to determine variables associated with discordance
      between the distance walked during an in-hospital 6-minute walking test (6MWT) and the
      average distance travelled per day (observed over a period of 28 days (2 × 14 days) using a
      pedometer) among PH patients.
Secondarily, the discordance between 6MWT results versus total pedometer recorded distance
      and versus maximum daily pedometer-recorded distance will be similarly studied. The aim of
      the study is also to search for variables associated with progression free survival. The
      relationships between pedometer data and self-reported dyspnea variation will be studied.
      Factorial analysis may be used to study the overall view of variable correlations and patient
      similarity/dissimilarity.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: In this first study, the links between variables and discordance between walking test and pedometer results will be searched.
primary purpose: Diagnostic
masking: None (Open Label)
measure: The patient's discordance category as precisely defined here:
time frame: 74 days
description: Linear regression is performed for the distance walked during an initial 6 minute walking test (6MWT) and the average distance walked per day according to the pedometer intervention. The residuals from this regression will determine categories:
Category 1 (pedometer high): the 25% of subjects not in category 2 and with higher values for pedometer data
Category 2 (concordance): the 50% of included subjects with the smallest residuals in terms of absolute value.
Category 3 (6MWT high): the 25% of subjects not in category 2 and with higher values for 6MWT data
measure: Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
time frame: Day 0
description: This scale evaluates social, emotional and physical health of the patient through 11 questions.
measure: Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
time frame: Month 3
description: This scale evaluates social, emotional and physical health of the patient through 11 questions.
measure: Hospital Anxiety and Depression (HAD) scale
time frame: Day 0
description: It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
measure: Hospital Anxiety and Depression (HAD) scale
time frame: Month 3
description: It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
measure: State-Trait Anxiety Inventory (STAI) questionnaire
time frame: Day 0
description: The State-Trait Anxiety Inventory is a 20 question-scale. For each question 4 levels of response are possible from 1 (never) to 4 (always).
measure: State-Trait Anxiety Inventory (STAI) questionnaire
time frame: Month 3
description: The State-Trait Anxiety Inventory is a 20 question-scale. For each question 4 levels of response are possible from 1 (never) to 4 (always).
measure: Multidimensional Fatigue Inventory (MFI)-20 questionnaire
time frame: Day 0
description: This questionnaire assesses the severity of the patient fatigue through 20 questions. For each question, 4 levels of response are possible : from "not at all" to "completely".
measure: Multidimensional Fatigue Inventory (MFI)-20 questionnaire
time frame: Month 3
description: This questionnaire assesses the severity of the patient fatigue through 20 questions. For each question, 4 levels of response are possible : from "not at all" to "completely".
measure: Coping with Health Injuries and Problems Scale
time frame: Day 0
description: This questionnaire assesses how the patient responds to health injuries and problems with 32 questions. For each question 5 levels of response are possible from 1 (not at all) to 5 (always).
measure: Coping with Health Injuries and Problems Scale
time frame: Month 3
description: This questionnaire assesses how the patient responds to health injuries and problems with 32 questions. For each question 5 levels of response are possible from 1 (not at all) to 5 (always).
arm group label: The study population
arm group type: Experimental
description: The study population as described by eligibility criteria.
Intervention: 6 minute walking test Intervention: pedometer
intervention type: Device
intervention name: Pedometer
description: A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.
arm group label: The study population
intervention type: Other
intervention name: 6 minute walking test
description: Performed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study).
arm group label: The study population
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Arnaud Bourdin, MD, PhD
role: Study Director
affiliation: University Hospitals of Monpellier
last name: Laurence Halimi, PhD, psychologist
phone: +33.(0)4.67.33.07.45
email: l-halimi@chu-montpellier.fr
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
sharing ipd: No