Clinical trial NCT05552118: 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
Official title: A Post-Market, Prospective, Multi-Centre, Open-Label, Comparative, Interventional Study of Adult Cochlear Implant Speech Performance and Clinic Efficiency With Remote Care (Remote Check & Remote Assist) Compared With Standard of Care in the First 12 Months Post-initial Activation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: Cochlear Implant aftercare
Remote clinical management
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: QbD Clinical
name: Avania
name: TFS
First posted: 2022-09-23
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older (no upper age limit)
* Post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant
* Unilaterally implanted with a compatible Cochlear™ implant
* Currently using a compatible Cochlear™ Sound Processor
* 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
* Direct access to 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

Exclusion Criteria:

* 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
* Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)
* Abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the Investigator
* Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues
* 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
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* 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).

Primary outcomes:
measure: 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
timeFrame: 3 months post-activation (baseline) and 12 months post-activation
Secondary outcomes:
measure: 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
timeFrame: 3 months post-activation (baseline) and 12 months post-activation
measure: Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation
timeFrame: 3 months post-activation (baseline) and 12 months post-activation
measure: Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire.
timeFrame: 3 months post-activation (baseline) and 12 months post-activation
measure: Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire
timeFrame: 3 months post-activation (baseline) and 12 months post-activation
measure: Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation
timeFrame: 12 months post-activation
measure: Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation
timeFrame: 12 months post-activation
Other outcomes:
Locations:
city: Subiaco
country: Australia
facility: Ear Science Institute Australia
state: Western Australia
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bari
country: Italy
facility: University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
city: Padova
country: Italy
facility: Azienda Ospedale Università di Padova
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre Nijmegen
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
city: Bodelwyddan
country: United Kingdom
facility: Auditory Implant Centre, Glan Clwyd Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: London
country: United Kingdom
facility: St George's Hospital
Study officials:
affiliation: Cochlear
name: Katie Keyrouse
role: STUDY_DIRECTOR
References: