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

Deafness Clinical Trial

— COCHLESURV  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02890576
• Other study ID #: 13 6900 15
• Status: Withdrawn
• Start date: September 2019
• Est. completion date: September 2020

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• telemedicine
Monitoring of patients with cochlear implant with sessions of telemedicine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of movements avoided the center,	number of contacts have avoided moving the patient to the center	12 months after the inclusion
Secondary	The delay for the identification of malfunction		Up to 1 year
Secondary	The time spent by the health professional during a telemedicine session		Up to 1 year