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

NCT ID: NCT02890576

Last Updated: 2019-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Deafness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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telemedicine

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

telemedicine

Intervention Type OTHER

Monitoring of patients with cochlear implant with sessions of telemedicine

Interventions

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telemedicine

Monitoring of patients with cochlear implant with sessions of telemedicine

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Deguine, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital University of Toulouse

References

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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.

Reference Type BACKGROUND
PMID: 15189396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20053272 (View on PubMed)

Other Identifiers

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13 6900 15

Identifier Type: -

Identifier Source: org_study_id

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