Clinical trial NCT05566353: Telemonitoring in Cochlear Implant Patient Care
Official title: Evaluation of the Changes in Cochlear Implant Patients Care Pathway With the Use of Telemonitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: Remote monitoring
Cochlear implant
Telemedicine
Healthcare system
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Toulouse
name: Groupement Interrégional de Recherche Clinique et d'Innovation
name: Foundation maladies rares, France
name: Cochlear
First posted: 2022-10-04
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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:

* To compare a number of scheduled appointments during a period of Remote Check use versus a historical period of a traditional follow-up
* To compare a number of indispensable unscheduled visits (unavoidable with or without Remote Check use) with a number of unnecessary ones (avoidable with Remote Check)
* To measure the compliance of the Remote Check application use
* To assess quantitatively and qualitatively a number of implant failures/dysfunctions identified with Remote Check
* To evaluate for each study participant time spent by clinician to treat Remote Check analysis data uploaded to My Cochlear data base
* To assess patients satisfaction of Remote Check implementation in their healthcare routine
* To evaluate the quality of life specific to the Deaf before and after Remote Check use The study implies four visits for each patient. The inclusion visit (V0) is a routine check-up appointment in the implantation reference center. After the patient is informed and his/her consent is collected, the Remote Check application will be activated on his/her processor. Two next follow-up visits, V1 (V0+ 5 mois (± 0.5 mois)) and V2 (V0 + 11 mois (± 0.5 mois)), are remote visits with hearing test performed through Remote Check application. Final visit, V3 (V0 + 12 mois (± 0.5 mois)), corresponds to patient's annual check-up appointment. In case a problem with processor's functioning is detected during V2, it will be resolved at V3. Equipment verification will be also performed to detect failures missed by Remote Check.

Eligibility criteria: Inclusion Criteria:

* Subjects-users of uni- or bilateral cochlear implants (Cl24RE, series 400, 500 and 600) and Cochlear Nucleus processor CP1000 or CP1150 during one year minimum
* Subjects who have already renewed their processor at least once
* Subjects implanted for more than 5 years
* Over 20 years old
* Subjects with Apple or Android smartphones compatible with Remote Check

Exclusion criteria:

* Associated physical (visual, motor...) or severe cognitive (dementia, specific language development troubles) making impossible the use of smartphone software and the conduction of hearing tests
* Patients unable to give oral informed consent
* Patients residing in geographical zones with limited internet access
* Subjects deprived of liberty by juridical or administrative decision
* Patients subjected to legal protection measures (guardianship or curatorship)
* Subjects for whom French is not a native language

Primary outcomes:
measure: Patients with at least one unscheduled follow-up visit
timeFrame: 24 months from the start of the study
Secondary outcomes:
measure: Scheduled and unscheduled visits during 1 year
timeFrame: 24 months from the start of the study
measure: Compliance measures
timeFrame: 24 months from the start of the study
measure: Equipment failures and dysfunctions
timeFrame: 24 months from the start of the study
measure: Time spent in MyCochlear for each patient
timeFrame: 24 months from the start of the study
measure: Patient satisfaction
timeFrame: 24 months from the start of the study
measure: Patient's Quality of Life
timeFrame: 24 months from the start of the study
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Montpellier
Study officials:
References: