<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/NCT04473313</url>
  </required_header>
  <id_info>
    <org_study_id>EDURESPI (29BRC20.0212</org_study_id>
    <nct_id>NCT04473313</nct_id>
  </id_info>
  <brief_title>Educational Follow-up in COPD Patients After Pulmonary Rehabilitation.</brief_title>
  <acronym>EDURESPI</acronym>
  <official_title>Educational Follow-up in COPD Patients After Pulmonary Rehabilitation: a Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      After pulmonary rehabilitation, the challenge is to maintain the benefits reached during the&#xD;
      program and increase physical activity.&#xD;
&#xD;
      As exercise training, education is the corner stone of pulmonary rehabilitation. Education&#xD;
      allows to support behavioral changes in daily life.&#xD;
&#xD;
      Recommendations about modalities for maintaining physical activity are still clear, however&#xD;
      for educational follow up recommendations need to be clarified.&#xD;
&#xD;
      After a pulmonary rehabilitation program, there is no defined plan for educational follow up&#xD;
      nor location to perform education session.&#xD;
&#xD;
      The aim of this study is to evaluate the proportion of patients who succeed to establish and&#xD;
      maintain the objectives they defined during the pulmonary rehabilitation program, one year&#xD;
      after this program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Anticipated">August 16, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 16, 2022</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>Realization of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end end of the pulmonary rehabilitation program</measure>
    <time_frame>one year</time_frame>
    <description>Determination of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end of the pulmonary rehabilitation program and evaluation of the realization of this (these) objective(s) after one year (yes or no)</description>
  </primary_outcome>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients, all stages&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients COPD patients admitted for pulmonary rehabilitation program in pulmonary&#xD;
             rehabilitation unit of CH des Pays de Morlaix or CHU Brest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to answer to the questionnaire&#xD;
&#xD;
          -  refusal to participate.&#xD;
&#xD;
          -  inability to perform the pulmonary rehabilitation program.&#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>Marc Beaumont, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH des pays de Morlaix</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc BEAUMONT</last_name>
    <phone>02 98 62 61 60</phone>
    <email>mbeaumont@ch-morlaix.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Francis Couturaud, MD, PhD</last_name>
      <email>Francis.couturaud@chu-Brest.fr</email>
    </contact>
    <contact_backup>
      <last_name>Eloïse Philippe</last_name>
      <email>eloise.philippe@chu-brest.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Francis Couturaud, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eloïse Philippe</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BEAUMONT</name>
      <address>
        <city>Morlaix</city>
        <zip>29672</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc BEAUMONT, PhD</last_name>
      <email>mbeaumont@ch-morlaix.fr</email>
    </contact>
    <contact_backup>
      <last_name>Eloïse Philippe</last_name>
      <email>eloise.philippe@chu-brest.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Catherine Le Ber, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Loïc Péran, PT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne Cécile Berriet, PT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc Beaumont, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Patricia Le Mevel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.</citation>
    <PMID>24127811</PMID>
  </reference>
  <reference>
    <citation>Peran L, Le Ber C, Pichon R, Cabillic M, Beaumont M. [Follow-up and evaluation of plans developed during pulmonary rehabilitation]. Rev Mal Respir. 2018 Nov;35(9):929-938. doi: 10.1016/j.rmr.2018.08.002. Epub 2018 Sep 7. French.</citation>
    <PMID>30201399</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</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>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/NCT04473313
org study id: EDURESPI (29BRC20.0212
nct id: NCT04473313
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After pulmonary rehabilitation, the challenge is to maintain the benefits reached during the
      program and increase physical activity.

      As exercise training, education is the corner stone of pulmonary rehabilitation. Education
      allows to support behavioral changes in daily life.

      Recommendations about modalities for maintaining physical activity are still clear, however
      for educational follow up recommendations need to be clarified.

      After a pulmonary rehabilitation program, there is no defined plan for educational follow up
      nor location to perform education session.

      The aim of this study is to evaluate the proportion of patients who succeed to establish and
      maintain the objectives they defined during the pulmonary rehabilitation program, one year
      after this program.
observational model: Cohort
time perspective: Prospective
measure: Realization of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end end of the pulmonary rehabilitation program
time frame: one year
description: Determination of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end of the pulmonary rehabilitation program and evaluation of the realization of this (these) objective(s) after one year (yes or no)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Beaumont, PhD
role: Principal Investigator
affiliation: CH des pays de Morlaix
last name: Marc BEAUMONT
phone: 02 98 62 61 60
email: mbeaumont@ch-morlaix.fr
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
citation: Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.
PMID: 24127811
citation: Peran L, Le Ber C, Pichon R, Cabillic M, Beaumont M. [Follow-up and evaluation of plans developed during pulmonary rehabilitation]. Rev Mal Respir. 2018 Nov;35(9):929-938. doi: 10.1016/j.rmr.2018.08.002. Epub 2018 Sep 7. French.
PMID: 30201399
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive