Feasibility of Remote Cochlear Implant Users' Follow-up (TELERIC1)
Primary Purpose
Deafness; Perception, Bilateral
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telemedicine
Sponsored by
About this trial
This is an interventional supportive care trial for Deafness; Perception, Bilateral focused on measuring cochlear implant ;
Eligibility Criteria
Inclusion Criteria:
- Patients with cochlear implants for more than 12 months followed by CRIC
- native French language
- possibility to carry out the sessions (remote and on-site) within a short time (30 days +/- 8 days) .Patients who can have a computer with internet connection quality and user of remote access type Skype in good conditions Listening, privacy and anonymity.
- Having given their consent to participate in this protocol
Exclusion Criteria:
- Unavailability to carry out the acts of telemedicine
- Difficulty having good quality remote access from home
- Not benefiting from a social protection scheme
- Persons deprived of their liberty by judicial or administrative decision
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A start with the remote session followed by on site
group B start with on site followed by telemedecine
Arm Description
Outcomes
Primary Outcome Measures
comparison the data of the medical consultation and speech therapy assessment, carried out in the CRIC service and videoconferencing when the patient is home, using his computer equipment to communicate with the CRIC
No differences between the speech data and the consultation data for acts at a distance compared to face-to-face acts.
Secondary Outcome Measures
Full Information
NCT ID
NCT03022227
First Posted
January 12, 2017
Last Updated
September 28, 2017
Sponsor
Hôpital Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT03022227
Brief Title
Feasibility of Remote Cochlear Implant Users' Follow-up
Acronym
TELERIC1
Official Title
Comparison of Remote Versus Standard On-site Care for Long Term Follow-up of Adult Cochlear Implant Users: a Prospective Controlled Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Rothschild
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cochlear implants (CIs) are medical devices now widely used in persons with severe to profound hearing loss. After a six month to one-year period following implantation, adults typically reach optimal fitting parameters, which lead to a stabilized hearing performance with their CI. At this stage, they usually enter a routine clinical after-care program, which involves regular appointmentsattheir CI center. Such visits aim at identifying any complication, which can be medical (abnormal cutaneous healing evolution) and/or device related, as well as any declinein performance (possibly related to the former). In France, the HAS (French Health Authority) recommends CI users tobe seen around threetimes a year during the second and third years after implantation, and then annually. While the schedule of appointments remains dependent on centers' practices, there is some kind of consensus about the minimal content of a long-term follow-up session:medical consultation, CI external parts checking, free field aided tonal audiometry, fitting adjustments if necessary,speech understanding assessments.
Our center (CRIC) is one of the biggest French CI implant centers approved by the HAS, providing after-care for no less than 750 CI users, most of whomhave entered their long-term follow-up period. For some, attending follow-up appointments may need several hours, require taking a half-day off work, and entail travel expenses. Some patients may also have associated disabilities making it difficultto reach the center.Moreover, although the cohort of patients has increased over the years, the number of trained professionals and the clinical care infrastructures have not evolved proportionally. As a consequence, there is a need to reduce the number of routine visits, to allow more scope for complex cases andto efficiently identify issues.
Remote consultation seems to address all the points listed above. However, it appears that little has been doneto develop remote after-care for cochlear implant recipients. Published studies mainly focus on the fitting aspects.
The development of telemedicine has become one of the key priorities of the French government over the past few years, and it is now feasible thanks to the development of high speed connections (ADSL, mobile internet, high definition transmissions). Promoting telemedicine has several goals, the main one being to extend health care services to underserved patients in remote locations; it also allows some medical units to be freed upand to reserve infrastructures and professionals for patients requesting critical care. Of course, telemedicine is also meant to save costs.
The objectif of this protocole is to evaluate the feasibility of telemedicine applied to adult cochlear implant users' follow-up by comparing the data of the medical consultation and speech therapy assessment, carried out in the CRIC service and videoconferencing when the patient is home, using his computer equipment to communicate with the CRIC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness; Perception, Bilateral
Keywords
cochlear implant ;
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A start with the remote session followed by on site
Arm Type
Experimental
Arm Title
group B start with on site followed by telemedecine
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
telemedicine
Intervention Description
telemedicine applied to adult cochlear implant users' follow-up
Primary Outcome Measure Information:
Title
comparison the data of the medical consultation and speech therapy assessment, carried out in the CRIC service and videoconferencing when the patient is home, using his computer equipment to communicate with the CRIC
Description
No differences between the speech data and the consultation data for acts at a distance compared to face-to-face acts.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with cochlear implants for more than 12 months followed by CRIC
native French language
possibility to carry out the sessions (remote and on-site) within a short time (30 days +/- 8 days) .Patients who can have a computer with internet connection quality and user of remote access type Skype in good conditions Listening, privacy and anonymity.
Having given their consent to participate in this protocol
Exclusion Criteria:
Unavailability to carry out the acts of telemedicine
Difficulty having good quality remote access from home
Not benefiting from a social protection scheme
Persons deprived of their liberty by judicial or administrative decision
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Remote Cochlear Implant Users' Follow-up
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