Feasibility of Remote Cochlear Implant Users' Follow-up

NCT ID: NCT03022227

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

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.

Conditions

Deafness; Perception, Bilateral

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

group A start with the remote session followed by on site

Group Type: EXPERIMENTAL

telemedicine

Intervention Type: OTHER

telemedicine applied to adult cochlear implant users' follow-up

group B start with on site followed by telemedecine

Group Type: ACTIVE_COMPARATOR

telemedicine

Intervention Type: OTHER

telemedicine applied to adult cochlear implant users' follow-up

Interventions

telemedicine

telemedicine applied to adult cochlear implant users' follow-up

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Rothschild

OTHER

Sponsor Role: lead

Responsible Party

Christine PONCET-WALLET

head of Service CRIC ENT Hôpital Rothschild

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2014-A01871-46

Identifier Type: -

Identifier Source: org_study_id