- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890576
Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV (COCHLESURV)
Organization of Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant.
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.
Study Overview
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 Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
telemedicine
Setting up of a new organization of medical monitoring (ussing telemedicine) of patient having a cochlear implant
|
Monitoring of patients with cochlear implant with sessions of telemedicine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of movements avoided the center,
Time Frame: 12 months after the inclusion
|
number of contacts have avoided moving the patient to the center
|
12 months after the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The delay for the identification of malfunction
Time Frame: Up to 1 year
|
Up to 1 year
|
The time spent by the health professional during a telemedicine session
Time Frame: Up to 1 year
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier Deguine, MD, PhD, Hospital University of Toulouse
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13 6900 15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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