Clinical trial NCT02890576: Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV
Official title: Organization of Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Deafness
Keywords: cochlear implant
telemedicine
new organization of patient monitoring
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with deafness and having a cochlear implant

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the number of movements avoided the center,
timeFrame: 12 months after the inclusion
Secondary outcomes:
measure: The delay for the identification of malfunction
timeFrame: Up to 1 year
measure: The time spent by the health professional during a telemedicine session
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Hospital University of Toulouse
name: Olivier Deguine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
citation: Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.