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CompletedNCT03022227TELERIC1Updated Oct 2, 2017

Feasibility of Remote Cochlear Implant Users' Follow-up

An interventional study of telemedicine in Deafness; Perception, Bilateral, sponsored by Hôpital Rothschild. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Hôpital Rothschild · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Deafness; Perception, Bilateral

Keywords

  • cochlear implant ;
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    group A start with the remote session followed by on site

    Other: telemedicine

  • Active comparator
    group B start with on site followed by telemedecine

    Other: telemedicine

Interventions

  • Othertelemedicine

    telemedicine applied to adult cochlear implant users' follow-up

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03022227
Lead sponsor
Hôpital Rothschild
Responsible party
Christine PONCET-WALLET (head of Service CRIC ENT Hôpital Rothschild, Hôpital Rothschild) — Principal investigator
First posted
Jan 16, 2017
Start date
May 2015
Primary completion
Jun 2015
Completion
Mar 2016
Last update
Oct 2, 2017

Oversight

Data monitoring committee
No
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