<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/NCT03022227</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A01871-46</org_study_id>
    <nct_id>NCT03022227</nct_id>
  </id_info>
  <brief_title>Feasibility of Remote Cochlear Implant Users' Follow-up</brief_title>
  <acronym>TELERIC1</acronym>
  <official_title>Comparison of Remote Versus Standard On-site Care for Long Term Follow-up of Adult Cochlear Implant Users: a Prospective Controlled Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Rothschild</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cochlear implants (CIs) are medical devices now widely used in persons with severe to&#xD;
      profound hearing loss. After a six month to one-year period following implantation, adults&#xD;
      typically reach optimal fitting parameters, which lead to a stabilized hearing performance&#xD;
      with their CI. At this stage, they usually enter a routine clinical after-care program, which&#xD;
      involves regular appointmentsattheir CI center. Such visits aim at identifying any&#xD;
      complication, which can be medical (abnormal cutaneous healing evolution) and/or device&#xD;
      related, as well as any declinein performance (possibly related to the former). In France,&#xD;
      the HAS (French Health Authority) recommends CI users tobe seen around threetimes a year&#xD;
      during the second and third years after implantation, and then annually. While the schedule&#xD;
      of appointments remains dependent on centers' practices, there is some kind of consensus&#xD;
      about the minimal content of a long-term follow-up session:medical consultation, CI external&#xD;
      parts checking, free field aided tonal audiometry, fitting adjustments if necessary,speech&#xD;
      understanding assessments.&#xD;
&#xD;
      Our center (CRIC) is one of the biggest French CI implant centers approved by the HAS,&#xD;
      providing after-care for no less than 750 CI users, most of whomhave entered their long-term&#xD;
      follow-up period. For some, attending follow-up appointments may need several hours, require&#xD;
      taking a half-day off work, and entail travel expenses. Some patients may also have&#xD;
      associated disabilities making it difficultto reach the center.Moreover, although the cohort&#xD;
      of patients has increased over the years, the number of trained professionals and the&#xD;
      clinical care infrastructures have not evolved proportionally. As a consequence, there is a&#xD;
      need to reduce the number of routine visits, to allow more scope for complex cases andto&#xD;
      efficiently identify issues.&#xD;
&#xD;
      Remote consultation seems to address all the points listed above. However, it appears that&#xD;
      little has been doneto develop remote after-care for cochlear implant recipients. Published&#xD;
      studies mainly focus on the fitting aspects.&#xD;
&#xD;
      The development of telemedicine has become one of the key priorities of the French government&#xD;
      over the past few years, and it is now feasible thanks to the development of high speed&#xD;
      connections (ADSL, mobile internet, high definition transmissions). Promoting telemedicine&#xD;
      has several goals, the main one being to extend health care services to underserved patients&#xD;
      in remote locations; it also allows some medical units to be freed upand to reserve&#xD;
      infrastructures and professionals for patients requesting critical care. Of course,&#xD;
      telemedicine is also meant to save costs.&#xD;
&#xD;
      The objectif of this protocole is to evaluate the feasibility of telemedicine applied to&#xD;
      adult cochlear implant users' follow-up by comparing the data of the medical consultation and&#xD;
      speech therapy assessment, carried out in the CRIC service and videoconferencing when the&#xD;
      patient is home, using his computer equipment to communicate with the CRIC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>comparison the data of the medical consultation and speech therapy assessment, carried out in the CRIC service and videoconferencing when the patient is home, using his computer equipment to communicate with the CRIC</measure>
    <time_frame>18 months</time_frame>
    <description>No differences between the speech data and the consultation data for acts at a distance compared to face-to-face acts.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Deafness; Perception, Bilateral</condition>
  <arm_group>
    <arm_group_label>group A start with the remote session followed by on site</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group B start with on site followed by telemedecine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>telemedicine</intervention_name>
    <description>telemedicine applied to adult cochlear implant users' follow-up</description>
    <arm_group_label>group A start with the remote session followed by on site</arm_group_label>
    <arm_group_label>group B start with on site followed by telemedecine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cochlear implants for more than 12 months followed by CRIC&#xD;
&#xD;
          -  native French language&#xD;
&#xD;
          -  possibility to carry out the sessions (remote and on-site) within a short time (30&#xD;
             days +/- 8 days) .Patients who can have a computer with internet connection quality&#xD;
             and user of remote access type Skype in good conditions Listening, privacy and&#xD;
             anonymity.&#xD;
&#xD;
          -  Having given their consent to participate in this protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unavailability to carry out the acts of telemedicine&#xD;
&#xD;
          -  Difficulty having good quality remote access from home&#xD;
&#xD;
          -  Not benefiting from a social protection scheme&#xD;
&#xD;
          -  Persons deprived of their liberty by judicial or administrative decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Rothschild</investigator_affiliation>
    <investigator_full_name>Christine PONCET-WALLET</investigator_full_name>
    <investigator_title>head of Service CRIC ENT Hôpital Rothschild</investigator_title>
  </responsible_party>
  <keyword>cochlear implant ;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</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/NCT03022227
org study id: 2014-A01871-46
nct id: NCT03022227
lead sponsor: 
has dmc: No
Cochlear implants (CIs) are medical devices now widely used in persons with severe to
      profound hearing loss. After a six month to one-year period following implantation, adults
      typically reach optimal fitting parameters, which lead to a stabilized hearing performance
      with their CI. At this stage, they usually enter a routine clinical after-care program, which
      involves regular appointmentsattheir CI center. Such visits aim at identifying any
      complication, which can be medical (abnormal cutaneous healing evolution) and/or device
      related, as well as any declinein performance (possibly related to the former). In France,
      the HAS (French Health Authority) recommends CI users tobe seen around threetimes a year
      during the second and third years after implantation, and then annually. While the schedule
      of appointments remains dependent on centers' practices, there is some kind of consensus
      about the minimal content of a long-term follow-up session:medical consultation, CI external
      parts checking, free field aided tonal audiometry, fitting adjustments if necessary,speech
      understanding assessments.

      Our center (CRIC) is one of the biggest French CI implant centers approved by the HAS,
      providing after-care for no less than 750 CI users, most of whomhave entered their long-term
      follow-up period. For some, attending follow-up appointments may need several hours, require
      taking a half-day off work, and entail travel expenses. Some patients may also have
      associated disabilities making it difficultto reach the center.Moreover, although the cohort
      of patients has increased over the years, the number of trained professionals and the
      clinical care infrastructures have not evolved proportionally. As a consequence, there is a
      need to reduce the number of routine visits, to allow more scope for complex cases andto
      efficiently identify issues.

      Remote consultation seems to address all the points listed above. However, it appears that
      little has been doneto develop remote after-care for cochlear implant recipients. Published
      studies mainly focus on the fitting aspects.

      The development of telemedicine has become one of the key priorities of the French government
      over the past few years, and it is now feasible thanks to the development of high speed
      connections (ADSL, mobile internet, high definition transmissions). Promoting telemedicine
      has several goals, the main one being to extend health care services to underserved patients
      in remote locations; it also allows some medical units to be freed upand to reserve
      infrastructures and professionals for patients requesting critical care. Of course,
      telemedicine is also meant to save costs.

      The objectif of this protocole is to evaluate the feasibility of telemedicine applied to
      adult cochlear implant users' follow-up by comparing the data of the medical consultation and
      speech therapy assessment, carried out in the CRIC service and videoconferencing when the
      patient is home, using his computer equipment to communicate with the CRIC.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: comparison the data of the medical consultation and speech therapy assessment, carried out in the CRIC service and videoconferencing when the patient is home, using his computer equipment to communicate with the CRIC
time frame: 18 months
description: No differences between the speech data and the consultation data for acts at a distance compared to face-to-face acts.
arm group label: group A start with the remote session followed by on site
arm group type: Experimental
arm group label: group B start with on site followed by telemedecine
arm group type: Active Comparator
intervention type: Other
intervention name: telemedicine
description: telemedicine applied to adult cochlear implant users' follow-up
arm group label: group A start with the remote session followed by on site
arm group label: group B start with on site followed by telemedecine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hôpital Rothschild
investigator full name: Christine PONCET-WALLET
investigator title: head of Service CRIC ENT Hôpital Rothschild
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
sharing ipd: No