<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/NCT03750331</url>
  </required_header>
  <id_info>
    <org_study_id>1708232</org_study_id>
    <secondary_id>2018-A00677-48</secondary_id>
    <nct_id>NCT03750331</nct_id>
  </id_info>
  <brief_title>Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.</brief_title>
  <acronym>APT'x</acronym>
  <official_title>Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Transplant Centers are facing new organisational challenges with regards to the growing&#xD;
      number of patients they have to follow-up. We have developed and assessed the feasibility of&#xD;
      using a novel web application permitting a medically-tailored follow-up of stable renal&#xD;
      transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the&#xD;
      organization of patients' follow-up at the Transplant Centre level as well as to provide&#xD;
      secondary individual benefits in terms of therapeutic education, adherence to treatment and&#xD;
      eventually to improve long term outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) to (ii) a group of patients assisted by Ap'TELACARE and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients experiencing at least one episode of graft dysfunction</measure>
    <time_frame>2 years</time_frame>
    <description>graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure of immunosuppressive treatment</measure>
    <time_frame>2 years</time_frame>
    <description>Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients who needed to return to dialysis</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with acute or chronic transplant rejection</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-transplant complication</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed</measure>
    <time_frame>2 years</time_frame>
    <description>EuroQol group - 5 Dimensions ( EQ-5D) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of anxiety and depression</measure>
    <time_frame>2 years</time_frame>
    <description>Hospital Anxiety and Depression (HAD) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental cost-effectiveness evaluation criteria</measure>
    <time_frame>2 years</time_frame>
    <description>Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation criteria for the Budget Impact Analysis</measure>
    <time_frame>2 years</time_frame>
    <description>Average cost saved per 100 patients treated in the &quot;Ap'Telecare group&quot; compared to the &quot;traditional follow-up&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">738</enrollment>
  <condition>Renal Transplantation</condition>
  <arm_group>
    <arm_group_label>traditional patient follow-up</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>medically-tailored follow-up with Ap'Telecare</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a group of patients assisted by Ap'Telecare and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ap'Telecare</intervention_name>
    <description>an internet application on a computer, tablet or smartphone</description>
    <arm_group_label>medically-tailored follow-up with Ap'Telecare</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional schedule</intervention_name>
    <description>a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule</description>
    <arm_group_label>traditional patient follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients transplanted for at least 3 months&#xD;
&#xD;
          -  Stable renal graft function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No home internet access&#xD;
&#xD;
          -  Major disability&#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>Christophe Mariat, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Saint-Etienne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christophe Mariat, MD PhD</last_name>
    <phone>(0)477828739</phone>
    <phone_ext>+33</phone_ext>
    <email>christophe.mariat@univ-st-etienne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carine Labruyere, CRA</last_name>
    <phone>(0)477120469</phone>
    <phone_ext>+33</phone_ext>
    <email>carine.labruyere@chu-st-etienne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clermont-Ferrand, CHU Site Gabriel-Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Anne-Elisabeth HENG, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cyril GARROUSTE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alba ATENZA, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Clément DUMOND, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carole PHILIPPONNET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valentin MAYET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christophe MARIAT, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric ALAMARTINE, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Miriana DINIC, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ingrid MASSON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas MAILLARD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian BROYET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Damien THIBAUDIN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guillaume CLAISSE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hesham MOHEY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>telemedicine</keyword>
  <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/NCT03750331
org study id: 1708232
secondary id: 2018-A00677-48
nct id: NCT03750331
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Transplant Centers are facing new organisational challenges with regards to the growing
      number of patients they have to follow-up. We have developed and assessed the feasibility of
      using a novel web application permitting a medically-tailored follow-up of stable renal
      transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the
      organization of patients' follow-up at the Transplant Centre level as well as to provide
      secondary individual benefits in terms of therapeutic education, adherence to treatment and
      eventually to improve long term outcome.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) to (ii) a group of patients assisted by Ap'TELACARE and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).
primary purpose: Other
masking: None (Open Label)
measure: Patients experiencing at least one episode of graft dysfunction
time frame: 2 years
description: graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)
measure: Failure of immunosuppressive treatment
time frame: 2 years
description: Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic
measure: number of patients who needed to return to dialysis
time frame: 2 years
measure: number of patients with acute or chronic transplant rejection
time frame: 2 years
measure: Post-transplant complication
time frame: 2 years
measure: Death
time frame: 2 years
measure: Quality of life assessed
time frame: 2 years
description: EuroQol group - 5 Dimensions ( EQ-5D) scale
measure: Level of anxiety and depression
time frame: 2 years
description: Hospital Anxiety and Depression (HAD) scale
measure: Incremental cost-effectiveness evaluation criteria
time frame: 2 years
description: Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale).
measure: Evaluation criteria for the Budget Impact Analysis
time frame: 2 years
description: Average cost saved per 100 patients treated in the "Ap'Telecare group" compared to the "traditional follow-up".
arm group label: traditional patient follow-up
arm group type: Active Comparator
description: a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter)
arm group label: medically-tailored follow-up with Ap'Telecare
arm group type: Experimental
description: a group of patients assisted by Ap'Telecare and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).
intervention type: Other
intervention name: Ap'Telecare
description: an internet application on a computer, tablet or smartphone
arm group label: medically-tailored follow-up with Ap'Telecare
intervention type: Other
intervention name: traditional schedule
description: a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule
arm group label: traditional patient follow-up
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christophe Mariat, MD PhD
role: Principal Investigator
affiliation: CHU Saint-Etienne
last name: Christophe Mariat, MD PhD
phone: (0)477828739
phone ext: +33
email: christophe.mariat@univ-st-etienne.fr
last name: Carine Labruyere, CRA
phone: (0)477120469
phone ext: +33
email: carine.labruyere@chu-st-etienne.fr
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No