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Feasibility of Remote Cochlear Implant Users' Follow-up (TELERIC1)

Primary Purpose

Deafness; Perception, Bilateral

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telemedicine
Sponsored by
Hôpital Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deafness; Perception, Bilateral focused on measuring cochlear implant ;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with cochlear implants for more than 12 months followed by CRIC
  • native French language
  • possibility to carry out the sessions (remote and on-site) within a short time (30 days +/- 8 days) .Patients who can have a computer with internet connection quality and user of remote access type Skype in good conditions Listening, privacy and anonymity.
  • Having given their consent to participate in this protocol

Exclusion Criteria:

  • Unavailability to carry out the acts of telemedicine
  • Difficulty having good quality remote access from home
  • Not benefiting from a social protection scheme
  • Persons deprived of their liberty by judicial or administrative decision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    group A start with the remote session followed by on site

    group B start with on site followed by telemedecine

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    No differences between the speech data and the consultation data for acts at a distance compared to face-to-face acts.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2017
    Last Updated
    September 28, 2017
    Sponsor
    Hôpital Rothschild
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03022227
    Brief Title
    Feasibility of Remote Cochlear Implant Users' Follow-up
    Acronym
    TELERIC1
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hôpital Rothschild

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deafness; Perception, Bilateral
    Keywords
    cochlear implant ;

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group A start with the remote session followed by on site
    Arm Type
    Experimental
    Arm Title
    group B start with on site followed by telemedecine
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    telemedicine
    Intervention Description
    telemedicine applied to adult cochlear implant users' follow-up
    Primary Outcome Measure Information:
    Title
    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
    Description
    No differences between the speech data and the consultation data for acts at a distance compared to face-to-face acts.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with cochlear implants for more than 12 months followed by CRIC native French language possibility to carry out the sessions (remote and on-site) within a short time (30 days +/- 8 days) .Patients who can have a computer with internet connection quality and user of remote access type Skype in good conditions Listening, privacy and anonymity. Having given their consent to participate in this protocol Exclusion Criteria: Unavailability to carry out the acts of telemedicine Difficulty having good quality remote access from home Not benefiting from a social protection scheme Persons deprived of their liberty by judicial or administrative decision

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Feasibility of Remote Cochlear Implant Users' Follow-up

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