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

NCT02890576 | Withdrawn

• 1 other identifier: 13 6900 15
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deafness

Keywords

cochlear implant; telemedicine; new organization of patient monitoring

Outcome Measures

Primary Outcomes (1)

• the number of movements avoided the center,

  number of contacts have avoided moving the patient to the center

  12 months after the inclusion

Secondary Outcomes (2)

• 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

Study Arms (1)

telemedicine

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

Other: telemedicine

Interventions

telemedicine OTHER

Monitoring of patients with cochlear implant with sessions of telemedicine

telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with deafness and having a cochlear implant

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Related 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. doi: 10.1111/j..2002.384.doc.x.

  PMID: 15189396 BACKGROUND

• 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.

  PMID: 20053272 BACKGROUND

MeSH Terms

Conditions

Deafness

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Olivier Deguine, MD, PhD

  Hospital University of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share