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| Name | Class |
|---|---|
| University Hospital, Toulouse | OTHER |
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
| Foundation maladies rares, France | UNKNOWN |
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Following a sufficient delay after the cochlear implantation and initial implant activation, the patient will return to the hospital for follow-up visits for equipment maintenance and auditory performance evaluation only once per year. This frequency might appear either insufficient, in which case an additional patient check-up will be arranged, or excessive if patient performances and implant adjustments are stable. Using at-home testing tool for remote hearing performance monitoring can thus appear advantageous for both patients and clinicians, allowing to avoid an unnecessary journey to the implantation reference center for the first and to diminish a number of unscheduled medical appointments for the second.
In December 2020, the French Medical Device and Health Technology Evaluation Committee (CNEDiMTS) voted in favour of the integration of telemonitoring in cochlear implant users' follow-up thus adding a range of new possibilities to a standard health care routine.
According to the official recommendations of the French National Authority for Health, a patient implanted for a sufficiently long time should be seen annually at the implantation reference center. This periodicity might appear too low, in which case a patient will have to organise an unscheduled check-up appointment. Such appointments are a source of various problems: firstly, they disorganise the routine of the reference centers not adapted for emergency and semi-emergency situations; secondly, the patient might encounter substantial travelling fees (only 22 refence centers in France), especially if an implant component to replace is out of stock. Having an utility of remote patient monitoring is also beneficial in situations where the access to health care system is restricted, for example, the recent pandemic of Covid 19.
Cochlear™ has recently designed an at-home based patient testing tool, Remote Check application, permitting to complete a series of hearing test from a compatible smartphone. The results are then sent to the implantation reference center and evaluated by healthcare professionals. The data is securely stored on Cloud accessible to authorised clinicians via MyCochlear site.
Although the feasibility and the accuracy in detecting technical problems of remote follow-up of people with cochlear implant had been already assessed, its impact on health care system is still unknown. Hence, this project will be the first to evaluate an interest of implementing remote monitoring in following adults with cochlear implantation.
The main objective of the study is - to determine if the use of telemonitoring through Remote Check application reduces significantly a number of unscheduled check-up appointments in the reference centre during 1 year follow-up period for a patient with a cochlear implant Cochlear™ in comparison to traditional health care approach.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients followed at the implantation reference centers | Experimental | Patients eligible for implant processor renewal in 2 years and corresponding to inclusion criteria will be enrolled during their routine check-up appointment at the implantation reference centers of the University Hospitals of Montpellier and Toulouse. Patients will be their own controls through the use of their medical history data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Check | Other | Remote Check is a remote monitoring tool which permits patients with Cochlear Nucleus CP1000 or CP1150 processors to complete hearing tests (pure-tone and speech-in-voice audiometry, electrode impedance measures, implant functioning assessment) at home, |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with at least one unscheduled follow-up visit | Annual percentage of patients-cochlear implant users having at least one unscheduled appointment at the reference center | 24 months from the start of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Scheduled and unscheduled visits during 1 year | The number of scheduled and unscheduled (avoidable and unavoidable) visits during 1 year | 24 months from the start of the study |
| Compliance measures |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric Venail, PhD, MD | Contact | +33467336890 | f-venail@chu-montpellier.fr | |
| Olivier Deguine, PhD, MD | Contact | +33561772211 | deguine.o@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Montpellier | Recruiting | Montpellier | France |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Cochlear |
| INDUSTRY |
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The compliance will be measured by the number of Remote Check assessments in one year after the start of remote monitoring. Assessments performed within the timeframe and after the deadline will be identified.
| 24 months from the start of the study |
| Equipment failures and dysfunctions | The number and the type of failures/dysfunctions identified by Remote Check | 24 months from the start of the study |
| Time spent in MyCochlear for each patient | Clinician login time spent on each subject's file on MyCochlear data base during the year of follow up | 24 months from the start of the study |
| Patient satisfaction | Patient satisfaction measured by the questionnaire validated in French language: "the Service User Technology Acceptability (SUTAQ)". Score will be assessed by 5 options from "Strongly disagree" (worse outcome), "Disagree somewhat", "Neither agree nor disagree", "agree somewhat" to "strongly agree" (better outcome) | 24 months from the start of the study |
| Patient's Quality of Life | Patient's quality of life score linked to deafness will be measured by the questionnaire Speech, Spatial and Qualities of Hearing scale (Sp-SSQ12) validated in french. Score will run from 0 (worse outcome) to 10 (better outcome) | 24 months from the start of the study |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |