Benefit of Connected Care for Cochlear Implant Management

Official title

Evaluating the Benefit of Integrating Connected Care to Reshape the Cochlear Implant Care Pathway: a Multicenter Randomized Non-inferiority Study

Overview

Some 30 hospitals in France are accredited to manage cochlear implant (CI) activity, which represents around 1,800 new patients implanted per year and an estimated active file of over 20,000 patients. The current patient pathway meets the requirements described in 2009 for this activity. Today, however, it is inflexible, not scalable, and presents major constraints for both patients and the healthcare professionals in charge of them. In the first year post-implantation, a patient visits his or her center on average 9 times for routine follow-up. The growing demand for patients to be implanted and the need to continue monitoring patients who have already been implanted are putting a strain on the centers responsible for this activity, leading to a deterioration in the management of this condition. We need to propose a new care pathway that meets current needs, improves patient service and optimizes the workload of our teams in order to manage their entire implant cohort. This project focuses on two areas in order to optimize the implant patient's care pathway. The first is to integrate telemonitoring into the follow-up process. Telemonitoring has already proved its worth in many therapeutic fields, and could clearly meet the needs of all those involved: Reduced time constraints, optimized on-site visits, flexibility in management, fewer people lost to follow-up... The second axis consists in optimizing the implant system activation stage, a cumbersome and complex step, by favoring early activation based on objective patient data collected intraoperatively. Reducing the variability of activation leads to earlier stabilization of settings, without compromising hearing performance. These two approaches are currently used in some centers, but not in combination, and have been adopted routinely in some countries. The expected benefits are therefore well known, but this project has a key role to play in demonstrating the feasibility and medico-economic benefits of our French model. This project will therefore jointly optimize early activation, made possible by objective intraoperative measurements, and patient management by integrating telemonitoring into the adult CI pathway to improve efficiency. The aim of this project is to evaluate, in the first year of post-CI follow-up, the benefits of this new, adapted care pathway, both in terms of the organization of care and the patient's quality of life and performance. The main hypothesis is that a new care pathway that integrates early activation and remote monitoring will enable the center to provide more flexible and adapted patient follow-up to optimize management, and thus improve quality of life without any deterioration in clinical effectiveness (hearing performance). The investigators aim to demonstrate the clinical non-inferiority of performance in noise (DTT Test) assessed at 12 months in patients benefiting from the new care pathway vs. current standard follow-up, while improving their quality of life, in a multicenter randomized controlled trial.

Interventions

• Other Standard-of-care
  Management of the first year post-CI follow-up according to current center practices
• Other Experimental hybrid care pathway
  First year post-CI follow-up including early activation of the implant and hybrid follow-up, including remote or in-center monitoring visits, adjustable according to the evolution of their hearing performance and comfort. In this new care pathway, compared with the Standard-of-care, the 2-week visit and the 9-month visit are omitted, due to early activation and remote follow-up. Visits at 1 and 6 months are the same as those in the conventional, on-site routine. Visits at 3 and 12 months will be

Primary outcome measures

• Hearing performance in noise [Time frame: At 12 months post-activation of the CI]

Eligibility criteria

Inclusion criteria

• Adult patients (aged 18 or over) eligible for a cochlear implant in primary implantation according to French National Authority for Health indications
• Patients suffering from severe to profound bilateral deafness with discrimination less than or equal to 50% on voice audiometry tests using the Fournier list (or equivalent).
• Patients affiliated to the public health insurance body
• Patients who benefit from a Cochlear® system with a processor compatible with Remote Care tools
• Patients using a smartphone compatible with the Nucleus Smart application.
• Patients who have given their written informed consent to the study
• French-speaking patients

Exclusion criteria

• Patients already implanted and candidates for implantation of the other ear (bilateralization), or previously implanted (re-implantation).
• Patients with concomitant illnesses that are incompatible with the use of remote monitoring,
• Pregnant women
• Patients suffering from unilateral deafness with incapacitating tinnitus
• Persons under legal protection (guardianship, curators).
• Subjects taking part in other interventional research with an exclusion period still in progress at the time of inclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07117968 · 69HCL24_0756

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗