Feasibility of Remote Cochlear Implant Users' Follow-up

NCT03022227 | Completed

• 1 other identifier: 2014-A01871-46
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

cochlear implant ;

Outcome Measures

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.

  18 months

Study Arms (2)

group A start with the remote session followed by on site

EXPERIMENTAL

Other: telemedicine

group B start with on site followed by telemedecine

ACTIVE COMPARATOR

Other: telemedicine

Interventions

telemedicine OTHER

telemedicine applied to adult cochlear implant users' follow-up

group A start with the remote session followed by on site; group B start with on site followed by telemedecine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Rothschild: lead

MeSH Terms

Conditions

Deafness

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of Service CRIC ENT Hôpital Rothschild

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 16, 2017
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: March 1, 2016
• Last Updated: October 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share