Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV

Withdrawn

• Conditions: Deafness
• Interventions: Other: telemedicine

• Registration Number: NCT02890576
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The number of patients with cochlear implants increases every year, constituting an active queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380 adult patients). The number of approved cochlear implant centers is limited by guardianships, and corresponds to the Hospitals University. It is not possible to create networks of correspondents. Teams of implantation centers must meet the needs of new patients and ensure continuity of care for patients already implanted: speech therapy monitoring, adjustment and rehabilitation.

In case of malfunction of the implant, patients use in first-line reference center. The increasing number of patients leads to a lack of specialized teams that can not meet the demands of patients in a timely manner, while continuing to provide support for new patients. It is therefore necessary to find solutions to improve the service provided to patients who received a cochlear implant system to respond quickly and effectively to the request of troubled patients, while optimizing the workload of the teams . The introduction of a telemedicine platform is expected to achieve these goals, distinguishing minor malfunctions, not requiring a consultation in a center, and the most complex situations requiring consultation in a center.

Detailed Description

The strategy of the study is to establish contact with the patient at home in case of problems through the establishment of a daily continuously in service by telephone contact and video calling.

There will be no change in the usual care of the patient. The monitoring center by health professionals (speech therapists, technicians and doctors ORL) in the cochlear implant center will operate a daily permanence of 5 half days on business days, to respond to a patient call.

Are excluded from this research, emergency management such as meningitis, which passes through the usual emergency lane.

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Study Start: 2019-09
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patient (> 18 years), carrying a cochlear implant,
• Familiar with using the Internet and with equipment (computer and computer video camera) at his home
• Agreeing to participate in the study,
• With a social protection system.

Exclusion Criteria

• Misunderstanding of login procedures,
• Failure to follow procedures,
• Person under a legal protection system (guardianship, curators or safeguard justice)
• Pregnancy or breastfeeding.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
telemedicine	telemedicine	Setting up of a new organization of medical monitoring (ussing telemedicine) of patient having a cochlear implant

Primary Outcome Measures

Name	Time	Method
the number of movements avoided the center,	12 months after the inclusion	number of contacts have avoided moving the patient to the center

Secondary Outcome Measures

Name	Time	Method
The delay for the identification of malfunction	Up to 1 year
The time spent by the health professional during a telemedicine session	Up to 1 year