Telemonitoring in Cochlear Implant Patient Care (EMPSICOT)

Evaluation of the Changes in Cochlear Implant Patients Care Pathway With the Use of Telemonitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Other: Remote Check

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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric Venail, PhD, MD; Phone Number: +33467336890; Email: f-venail@chu-montpellier.fr
• Study Contact Backup: Name: Olivier Deguine, PhD, MD; Phone Number: +33561772211; Email: deguine.o@chu-toulouse.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • University Hospital Montpellier
    • Contact: Frédéric Venail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients followed at the implantation reference centers; 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.

Other: Remote Check; 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Toulouse; Cochlear; Groupement Interrégional de Recherche Clinique et d'Innovation; Foundation maladies rares, France

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): June 20, 2025

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Remote monitoring; Cochlear implant; Healthcare system
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: RECHMPL21_0519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No