<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/NCT03295474</url>
  </required_header>
  <id_info>
    <org_study_id>FA-TELE-REHAB</org_study_id>
    <nct_id>NCT03295474</nct_id>
  </id_info>
  <brief_title>Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.</brief_title>
  <official_title>Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System (FA-TELE-REHAB)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ADIR Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ADIR Association</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>
      Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory&#xD;
      disease, however there is a lack of pulmonary rehabilitation centers. Telehealth technology&#xD;
      is one solution to deliver supervised home-based rehabilitation (tele-rehabilitation).&#xD;
&#xD;
      However, the feasibility and the acceptability of using telehealth technology to deliver&#xD;
      tele-rehabilitation has not been assessed in a large scale multicenter study.&#xD;
&#xD;
      Therefore, the aim of this study is to assess the feasibility and the acceptability of&#xD;
      telemonitoring system during pulmonary rehabilitation in patients with chronic respiratory&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</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>Ability of the patients to be autonomous when using the device.</measure>
    <time_frame>2 to 5 sessions for 100 different patients will be assessed for a total time frame a 1 year. Data will be collected after every sessions and presented as the number of patients autonomous when using the device</time_frame>
    <description>Number of patients autonomous when using the device will be presented for the the 2nd, 3rd, 4th and 5th session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's satisfaction assessed by Likert scale.</measure>
    <time_frame>2 to 5 sessions for 100 different patients will be assessed for a total time frame a 1 year. Outcome will be assessed during the sessions of every patient</time_frame>
    <description>Data will be presented as the patient's satisfaction of the system at the end of the 5 sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of the telemedicine gateway in providing data.</measure>
    <time_frame>2 to 5 sessions will be carried out for 100 patients for a total time frame of 1 year. For every patient, sessions will be carried out on separate days (with a minimum of 1 day of rest between sessions)</time_frame>
    <description>Data will be collected at the end of every sessions. Final endpoint will be the reliability of the telemedicine Gateway in providing data through study completion.&#xD;
Calculation : number of sessions provided by telemedicine gateway/number of scheduled sessions</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Pulmonary Rehabilitation</condition>
  <condition>Telemedicine</condition>
  <arm_group>
    <arm_group_label>Rehabilitation using telehealth technology</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation using telehealth technology</intervention_name>
    <description>Consecutive patients with chronic respiratory disease referred for pulmonary rehabilitation are offered to participate in the protocol.&#xD;
Patients are taught to use the system during the first session of aerobic training.&#xD;
During 2 to 5 sessions of aerobic training (depending on the number of sessions needed to be autonomous), they are monitored in the pulmonary rehabilitation center with an oximeter device (Nonin 3150).&#xD;
At the end of every session, patients are asked to answer to 3 questions on a Likert scale (see outcome session).&#xD;
The therapist also ascertains wether the telemonitoring gateway successfully provided informations regarding the session.&#xD;
The study takes off on the session during which the patients are autonomous in using the telehealthcare system.&#xD;
If patients are not autonomous on the fifth session, the study also takes off.</description>
    <arm_group_label>Rehabilitation using telehealth technology</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Every patients referred for pulmonary rehabilitation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years ;&#xD;
&#xD;
          -  Referred for pulmonary rehabilitation (every chronic respiratory disease accepted).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman or likely to be ;&#xD;
&#xD;
          -  Patient under guardianship ;&#xD;
&#xD;
          -  Neuropathic disorder ;&#xD;
&#xD;
          -  Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation.&#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>Catherine Tardif, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cuvelier Antoine, Prof, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tristan Bonnevie, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francis-Edouard Gravier, PT</last_name>
    <role>Study Chair</role>
    <affiliation>ADIR Association, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine Viacroze, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Debeaumont, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-François Muir, Prof, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bouchra Lamia, Prof, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean Quieffin, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guillaume Prieur, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Clément Médrinal, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ADIR Association</name>
      <address>
        <city>Bois-Guillaume</city>
        <zip>76230</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier du Havre</name>
      <address>
        <city>Le Havre</city>
        <zip>76600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>February 24, 2019</last_update_submitted>
  <last_update_submitted_qc>February 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</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/NCT03295474
org study id: FA-TELE-REHAB
nct id: NCT03295474
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory
      disease, however there is a lack of pulmonary rehabilitation centers. Telehealth technology
      is one solution to deliver supervised home-based rehabilitation (tele-rehabilitation).

      However, the feasibility and the acceptability of using telehealth technology to deliver
      tele-rehabilitation has not been assessed in a large scale multicenter study.

      Therefore, the aim of this study is to assess the feasibility and the acceptability of
      telemonitoring system during pulmonary rehabilitation in patients with chronic respiratory
      disease.
observational model: Cohort
time perspective: Prospective
measure: Ability of the patients to be autonomous when using the device.
time frame: 2 to 5 sessions for 100 different patients will be assessed for a total time frame a 1 year. Data will be collected after every sessions and presented as the number of patients autonomous when using the device
description: Number of patients autonomous when using the device will be presented for the the 2nd, 3rd, 4th and 5th session.
measure: Patient's satisfaction assessed by Likert scale.
time frame: 2 to 5 sessions for 100 different patients will be assessed for a total time frame a 1 year. Outcome will be assessed during the sessions of every patient
description: Data will be presented as the patient's satisfaction of the system at the end of the 5 sessions
measure: Reliability of the telemedicine gateway in providing data.
time frame: 2 to 5 sessions will be carried out for 100 patients for a total time frame of 1 year. For every patient, sessions will be carried out on separate days (with a minimum of 1 day of rest between sessions)
description: Data will be collected at the end of every sessions. Final endpoint will be the reliability of the telemedicine Gateway in providing data through study completion.
Calculation : number of sessions provided by telemedicine gateway/number of scheduled sessions
arm group label: Rehabilitation using telehealth technology
intervention type: Other
intervention name: Rehabilitation using telehealth technology
description: Consecutive patients with chronic respiratory disease referred for pulmonary rehabilitation are offered to participate in the protocol.
Patients are taught to use the system during the first session of aerobic training.
During 2 to 5 sessions of aerobic training (depending on the number of sessions needed to be autonomous), they are monitored in the pulmonary rehabilitation center with an oximeter device (Nonin 3150).
At the end of every session, patients are asked to answer to 3 questions on a Likert scale (see outcome session).
The therapist also ascertains wether the telemonitoring gateway successfully provided informations regarding the session.
The study takes off on the session during which the patients are autonomous in using the telehealthcare system.
If patients are not autonomous on the fifth session, the study also takes off.
arm group label: Rehabilitation using telehealth technology
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine Tardif, MD
role: Principal Investigator
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
last name: Cuvelier Antoine, Prof, PhD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
last name: Tristan Bonnevie, MsC
role: Study Chair
affiliation: ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
last name: Francis-Edouard Gravier, PT
role: Study Chair
affiliation: ADIR Association, Bois-Guillaume, France
last name: Catherine Viacroze, MD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
last name: David Debeaumont, MD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
last name: Jean-François Muir, Prof, PhD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France
last name: Bouchra Lamia, Prof, PhD
role: Study Chair
affiliation: UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
last name: Jean Quieffin, MD
role: Study Chair
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
last name: Guillaume Prieur, MsC
role: Study Chair
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
last name: Clément Médrinal, MsC
role: Study Chair
affiliation: UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive