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Remote Monitoring Applied to Cochlear Implant Patient Follow-up (TELESURVIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874533
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The cochlear implant (CI) is a device to compensate severe or profound deafness. The CI has a lifetime implanted part and an external processor. Regular monitoring is necessary because the device can generate complications and when the device is dysfunctional, the patient becomes deaf again. Our center, the CRIC, is a center for monitoring and fitting CI. Follow-up requires face-to-face procedures and some patients have difficulty accessing the center.

Our cohort of patients is growing steadily and now exceeds 750 patients. Provision should be made for sustained steady growth and enabling means. Telemedicine may be a response for the follow-up of some patients.

Currently, cochlear implanted patients benefit once a year from: an ENT (Ear Nose and Throat) medical consultation, a speech-language assessment, physical verification of the external processor, an audiometric test, a fitting of the external processor. This makes it possible to check the absence of medical complication, the use and the correct functioning of the external and internal parts.

Provision should be made for sustained steady growth and enabling means. With the development of new hearing tests, technical possibilities of some speech processors and software for their fitting, telemedicine may be a response for the follow-up of some patients.

TELESURVIC will study the feasibility for patients implanted with an implant Cochlear™ to carry out a complete test of their equipment by themselves.

For this project we will use a tablet device, without simultaneous contact with CRIC professionals. On this tablet are installed calibrated hearing tests, tutorials of good maintenance of the processor and a software of adjustment allowing the realization of the operations desired for an inspection of the implant.

Patients selected to participate, (on a voluntary basis), in this protocol will follow the following steps:

  1. They will first be trained in the use of the tablet at the CRIC by professionals. Patients will only be included if they are autonomous in handling the tablet and specific software;
  2. They will carry out the various tests at the hospital on the tablet: audiometry test in quiet and in noise then checking of the data logging, self-fitting thanks to the Cochlear software (NFS);
  3. Between one week and one month later, they will come back to the center and will do the same tests alone in a quiet room of the center.
  4. Outside the patient's presence, the data will be analyzed and compared with the data collected in step 2, in order to validate or not, the feasibility of these self-administrated tests without any help by the team.

Condition or disease Intervention/treatment Phase
Cochlear Diseases Device: Self-adjustment tests Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Remote Monitoring Applied to Cochlear Implant Patient Follow-up (TELESURVIC)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: self-adjustment tests

For patients with an implant Cochlear™, we will be trained during workshop, to use a tablet how to do some tests; They will do alone, by themselves the tests, just after the workshop and 8 to 30 days later.

Self audiometric test : digit triplet test, consonants discrimination test, Self-fitting of cochlear implant

Device: Self-adjustment tests

For patients with an implant Cochlear™, we will be trained during workshop, to use a tablet how to do some tests ; They will do alone, by themselves the tests, just after the workshop and 8 to 30 days later.

Self audiometric test : digit triplet test, consonants discrimination test, Self-fitting of cochlear implant





Primary Outcome Measures :
  1. The degree of auditory rehabilitation achieved with the cochlear implant. [ Time Frame: Between day +8 to +30 after the training session ]
    Comparison of the data collected (The hearing tests 3 digits test and VCV) during the usual evaluations in the department, then in auditory self-test and of the parameters of reaction just after an apprenticeship and at a distance, between 8 to 30 days, of this learning

  2. The degree of auditory rehabilitation achieved with the cochlear implant. [ Time Frame: Between day +8 to +30 after the training session ]
    Comparison of the data collected (the electrophysiological measures) during the usual evaluations in the department, then in auditory self-test and of the parameters of reaction just after an apprenticeship and at a distance, between 8 to 30 days, of this learning


Secondary Outcome Measures :
  1. Estimate the degree of patients satisfaction, on the use of new tools that will be used for remote monitoring [ Time Frame: Between day +8 to +30 after the training session ]
    For the patients: The results of Qualitative Self questionnaire, EVA scale, and free comments, according to the scoring manual, will be aggregated to estimate the degree of satisfaction.

  2. Estimate the degree of satisfaction professionals, on the use of new tools that will be used for remote monitoring [ Time Frame: Between day +8 to +30 after the training session ]
    For the professionals: The results of Qualitative Self questionnaire, EVA scale, and free comments, according to the scoring manual, will be aggregated to estimate the degree of satisfaction.

  3. Estimate the necessary adaptations of the medical team and patients [ Time Frame: Between day +8 to +30 after the training session ]

    When the patients come back (between Day +8 to Day+30), they do the same tests alone, by themselves. The staff checks if the results are the same as those of the tests at day 0, (without any medical or technical intercurrent event).

    We note the time spent for each test by the patient. Each professional involved in the process of teaching, coaching and assessing the patient through the study will fill a chart detailing his/her actions and keep a record of his/her dedicated time.

    By this approach, we hope building a team adapted to the remote monitoring applied to cochlear implant patient follow-up.


  4. Estimate time savings for professionals [ Time Frame: Between day +8 to +30 after the training session ]
    Comparison of the time spent for acts realized in a traditional way and the way according to the protocol, for professionals.

  5. Estimate time savings for patients [ Time Frame: Between day +8 to +30 after the training session ]
    Comparison of the time spent for acts realized in a traditional way and the way according to the protocol, for patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years old
  • Cochlear implantation older than 6 months (with a COCHLEAR implant and processor allowing wireless connection), followed by CRIC or IFIC,
  • Fluent in the French language,
  • Possibility of carrying out the acts alone in person in the service within a short time (less than 30 days).
  • Patients affiliated to a social security scheme or entitled to it
  • Patient who has signed informed consent form

Exclusion Criteria:

  • Difficulty mastering the tests alone or handling the tablet that will be entrusted to him
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons hospitalized without consent and without legal protection, and persons admitted to a health or social institution for purposes other than research.
  • Adults who are subject to a legal protection measure (guardianship, trusteeship or judicial protection), adults who are unable to express their consent and are not subject to a protection measure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874533


Contacts
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Contact: Christine PONCET WALLET, MD +33 1 40 19 36 61 christine.poncet@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christine PONCET WALLET, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03874533    
Other Study ID Numbers: APHP180004
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cochlear Implantation
telemonitoring
training workshop
Additional relevant MeSH terms:
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Cochlear Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases