The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
148
Cochlear™ Remote Check is a virtual assessment tool which helps the clinician to monitor the participant hearing progress remotely. It allows the participant to complete a series of hearing tests using the Cochlear™ Nucleus® Smart App then electronically send the results to the clinician for review. Cochlear™ Remote Assist enables a video call appointment through the Cochlear™ Custom Sound® Pro software and the Nucleus® Smart App. When remote check requires further follow-up, it allows the clinician to make programming adjustments and sound processor settings without a clinic visit.
Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro
Individuals who are implanted with a compatible cochlear implant series and compatible sound processor are eligible to participate.
Ear Science Institute Australia
Subiaco, Western Australia, Australia
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
Bari, Italy
Azienda Ospedale Università di Padova
Padova, Italy
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, Netherlands
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
Birmingham, United Kingdom
Auditory Implant Centre, Glan Clwyd Hospital
Bodelwyddan, United Kingdom
St Thomas' Hospital
London, United Kingdom
...and 1 more locations
Mean change in patient reported hearing ability in daily life measured with the SSQ12 (Speech, Spatial and Qualities of Hearing Scale) questionnaire between month 3 (baseline) and month 12 post-activation
Measuring change of speech, spatial and hearing experiences (12 items). Each item is scored on a scale of 0 to 10 where 0 corresponds to "complete inability or complete absence of a quality" and 10 to "complete ability or complete presence of an ability". The score of a participant is determined as the mean of the 12 items. Higher scores indicate less hearing disability
Time frame: 3 months post-activation (baseline) and 12 months post-activation
Mean change in speech recognition score for an open-set word recognition measure in quiet between 3 months post-activation (baseline) and 12 months post-activation
The test is done using phonetically balanced words and scores are recorded as % correct words. Higher scores indicate a better outcome.
Time frame: 3 months post-activation (baseline) and 12 months post-activation
Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation
The test is done using validated lists of phonetically balanced sentences. The noise is kept constant at 65 decibel (dB) Sound Pressure Level (SPL), and the speech is adapted stepwise to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. Lower scores indicate a better outcome.
Time frame: 3 months post-activation (baseline) and 12 months post-activation
Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire.
Time frame: 3 months post-activation (baseline) and 12 months post-activation
Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire
Time frame: 3 months post-activation (baseline) and 12 months post-activation
Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation
Measuring satisfaction of participants with the healthcare service (8 questions). Each item is scored using a 4-point Likert scale with 1 always indicating a negative response and 4 a positive response. A total higher score indicates higher satisfaction
Time frame: 12 months post-activation
Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation
Evaluating the knowledge, skills, beliefs, and behaviours that participants have for self-management of their long-term health condition (13 items). Each item is scored on a 4-point likert scale from 1 (strongly disagree) to 4 (strongly agree). The overall score is calculated and normalized to a 100-point scale. Higher scores indicate greater levels of activation.
Time frame: 12 months post-activation
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