Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation
- Conditions
- Hearing Loss
- Interventions
- Procedure: Cochlear™ Remote careProcedure: Standard of careDevice: Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)
- Registration Number
- NCT05552118
- Lead Sponsor
- Cochlear
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 148
- Aged 18 years or older (no upper age limit)
- Post-lingually deafened
- Unilaterally implanted with the CI600 Series (CI612, CI622, CI632),CI500 Series (CI512, CI522, CI532) or Freedom Series (CI24RE(CA),CI24RE(ST), CI422)
- Currently using a Nucleus 7 (CP1000) or Kanso 2 (CP1050) Sound Processor (or latest compatible Sound Processor)
- 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
- Owner of a compatible Smart Phone
- Fluent in the languages used for the study, as determined by the investigator
- Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
- Willing and able to provide written informed consent
-
Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming:
- Non-monopolar MAPs (bipolar, common ground, variable mode)
- Dynamic range of <10 Comfortable Level (CL)
- Hybrid mode enabled
- Pulse widths >100 µs
- 10 or more electrodes turned off
-
Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances
-
Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation
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Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)
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Abnormal cochlea anatomy and/or facial nerve stimulation
-
Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues
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Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
-
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
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Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
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Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cochlear™ Remote care Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor) Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist. Cochlear™ Remote care Cochlear™ Remote care Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist. Standard of care Standard of care Routine In-clinic care Standard of care Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor) Routine In-clinic care
- Primary Outcome Measures
Name Time Method 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 3 months post-activation (baseline) and 12 months 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
- Secondary Outcome Measures
Name Time Method 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 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.
Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation 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.
Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire. 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 3 months post-activation (baseline) and 12 months post-activation Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation 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.
Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation 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
Trial Locations
- Locations (10)
Azienda Ospedale Università di Padova
🇮🇹Padova, Italy
UZ Leuven
🇧🇪Leuven, Belgium
Radboud University Medical Centre Nijmegen
🇳🇱Nijmegen, Netherlands
UZ Gent
🇧🇪Gent, Belgium
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
🇮🇹Bari, Italy
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
🇬🇧Birmingham, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Auditory Implant Centre, Glan Clwyd Hospital
🇬🇧Bodelwyddan, United Kingdom
St Thomas' Hospital
🇬🇧London, United Kingdom