<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/NCT03005925</url>
  </required_header>
  <id_info>
    <org_study_id>9726</org_study_id>
    <nct_id>NCT03005925</nct_id>
  </id_info>
  <brief_title>Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis</brief_title>
  <acronym>SATIE-PR</acronym>
  <official_title>An Open Prospective Randomized Controlled Study Comparing the Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis Versus a Standard Outpatient Follow-up by Physical Consultation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Union</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Occitanie Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting&#xD;
      nearly 0.4% of the general population. It is a real public health issue. International&#xD;
      guidelines recommend strict control (remission or low disease activity) of the disease, to&#xD;
      avoid joint destruction in order to reduce the functional impact of the disease in the long&#xD;
      term and to improve the quality of life of the patients.&#xD;
&#xD;
      This care is based on a close follow-up requiring regular visits with the specialist which&#xD;
      represents an additional cost (transport, visits). In this context, tele-medicine is often&#xD;
      proposed as a complementary approach in the management of these chronic patients.&#xD;
&#xD;
      Thus, the investigators propose to study the interest of a connected device by comparing a&#xD;
      group of patients using this Smartphone application, coupled with a hand dynamometer during&#xD;
      the 6 months following initiation of a new DMARD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">August 16, 2016</start_date>
  <completion_date type="Actual">July 29, 2019</completion_date>
  <primary_completion_date type="Actual">July 29, 2019</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consultation</measure>
    <time_frame>follow up of patients over 6 months</time_frame>
    <description>To evaluate whether the use of a computerized monitoring interface on Smartphone ( &quot;SATIE-PR&quot; application) reduces the number of consultations during follow-up of patients with RA over 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of consultations</measure>
    <time_frame>follow up of patients over 6 months</time_frame>
    <description>% of patients who benefit from at least 4 consultations over a 6-month period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>connected group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>remote monitoring by smartphone in the care management of patients with rheumatoid arthritis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard outpatient follow-up by physical consultation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smartphone</intervention_name>
    <description>Smartphone application coupled with a hand dynamometer</description>
    <arm_group_label>connected group</arm_group_label>
    <other_name>tele medicine follow up</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical follow up</intervention_name>
    <description>regular visits with the specialist</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients between 18 and 75 years old with rheumatoid arthritis according to 2010 ACR&#xD;
             (American College of Rheumatology) / EULAR Classification Criteria&#xD;
&#xD;
               -  Patients that need a treatment initiation for rheumatoid arthritis&#xD;
&#xD;
               -  Patients with DAS 28 &gt; 3.2 (Disease Activity Score )&#xD;
&#xD;
               -  Patients who agreed to participate in this study and provide the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Insufficient level of understanding to perform the measurement and self-report&#xD;
             questionnaires&#xD;
&#xD;
               -  Patients without an internet connection&#xD;
&#xD;
               -  Difficulties in using a dynamometer due to a dominant-hand surgery done during&#xD;
                  the previous 12 months, carpal tunnel symptoms, or ulnar nerve compression, or&#xD;
                  cervicobrachial neuralgia, known presence of motor dysfunction of the upper&#xD;
                  extremity, or neurological disease&#xD;
&#xD;
               -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UH Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Pers YM, Valsecchi V, Mura T, Aouinti S, Filippi N, Marouen S, Letaief H, Le Blay P, Autuori M, Fournet D, Mercier G, Ferreira R, Jorgensen C. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis. Rheumatology (Oxford). 2021 Apr 6;60(4):1659-1668. doi: 10.1093/rheumatology/keaa462.</citation>
    <PMID>33020846</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT03005925
org study id: 9726
nct id: NCT03005925
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting
      nearly 0.4% of the general population. It is a real public health issue. International
      guidelines recommend strict control (remission or low disease activity) of the disease, to
      avoid joint destruction in order to reduce the functional impact of the disease in the long
      term and to improve the quality of life of the patients.

      This care is based on a close follow-up requiring regular visits with the specialist which
      represents an additional cost (transport, visits). In this context, tele-medicine is often
      proposed as a complementary approach in the management of these chronic patients.

      Thus, the investigators propose to study the interest of a connected device by comparing a
      group of patients using this Smartphone application, coupled with a hand dynamometer during
      the 6 months following initiation of a new DMARD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Consultation
time frame: follow up of patients over 6 months
description: To evaluate whether the use of a computerized monitoring interface on Smartphone ( "SATIE-PR" application) reduces the number of consultations during follow-up of patients with RA over 6 months
measure: Number of consultations
time frame: follow up of patients over 6 months
description: % of patients who benefit from at least 4 consultations over a 6-month period.
arm group label: connected group
arm group type: Experimental
description: remote monitoring by smartphone in the care management of patients with rheumatoid arthritis
arm group label: control group
arm group type: Active Comparator
description: standard outpatient follow-up by physical consultation
intervention type: Device
intervention name: Smartphone
description: Smartphone application coupled with a hand dynamometer
arm group label: connected group
other name: tele medicine follow up
intervention type: Other
intervention name: physical follow up
description: regular visits with the specialist
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: France
citation: Pers YM, Valsecchi V, Mura T, Aouinti S, Filippi N, Marouen S, Letaief H, Le Blay P, Autuori M, Fournet D, Mercier G, Ferreira R, Jorgensen C. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis. Rheumatology (Oxford). 2021 Apr 6;60(4):1659-1668. doi: 10.1093/rheumatology/keaa462.
PMID: 33020846
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No