Evaluation of the Changes in Cochlear Implant Patients Care Pathway With the Use of Telemonitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Patients with at least one unscheduled follow-up visit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Patients with at least one unscheduled follow-up visit
Time Frame: 24 months from the start of the study
Annual percentage of patients-cochlear implant users having at least one unscheduled appointment at the reference center
Secondary Outcomes
- Patient's Quality of Life(24 months from the start of the study)
- Scheduled and unscheduled visits during 1 year(24 months from the start of the study)
- Equipment failures and dysfunctions(24 months from the start of the study)
- Time spent in MyCochlear for each patient(24 months from the start of the study)
- Compliance measures(24 months from the start of the study)
- Patient satisfaction(24 months from the start of the study)