{
  "abstract": "Introduction Post-surgical care following cochlear implantation is a pivotal part of the rehabilitation journey for cochlear implant (CI) recipients. However, frequent in-clinic visits, particularly in the first year following CI activation, can place a significant burden on CI recipients. Moreover, the growing number of CI recipients may pose a challenge for CI clinics to provide consistent and lifelong care. Cochlear Remote Care is a platform that enables the delivery of post-surgical care through remote hearing assessments and remote video appointments, offering an opportunity to enhance clinic efficiency, eliminate geographical barriers, reduce financial burdens and provide flexible post-surgical options. The primary objective of this study is to compare self-reported hearing ability in daily life among CI recipients who receive post-surgical care through Remote Care with those receiving routine in-clinic care during the first year following CI activation. Additionally, the study will assess the time and costs associated with these care models for both the clinic and patients.Methods and analysis This multi-centre randomised controlled trial is set to be conducted across 11 clinics in the United Kingdom, Italy, the Netherlands, Belgium and Australia, with an anticipated sample size of 148 participants. All participants will be adults with post-lingual deafness and unilateral CIs. Following baseline measurements at 3 months post-activation, participants will be randomly assigned to either in-clinic visits or Remote Care appointments. At six and 12 months after activation, participants will complete a comprehensive battery of audiometric tests and questionnaires on patient-reported outcomes, usability and resource utilisation.Ethics and dissemination Ethics approval has been obtained for each clinical site. Study findings will be disseminated widely through peer-reviewed publications, lay language summaries and conference presentations.Trial registration number NCT05552118.",
  "authors": [
    {
      "affiliations": [
        "Otolaryngology Unit, Department of BMS, Neuroscience and Sensory Organs, University of Bari, Bari, Apulia, Italy"
      ],
      "name": "Nicola Quaranta"
    },
    {
      "affiliations": [
        "Otolaryngology Unit, Department of BMS, Neuroscience and Sensory Organs, University of Bari, Bari, Apulia, Italy"
      ],
      "name": "Alessandra Murri"
    },
    {
      "affiliations": [
        "Department of Otorhinolaryngology, Head and Neck Surgery, UZ, Leuven, Belgium",
        "KU Leuven Department of Neurosciences, ExpORL, Leuven, Belgium"
      ],
      "name": "Sam Denys"
    },
    {
      "affiliations": [
        "Department of Otorhinolaryngology, Head and Neck Surgery, UZ, Leuven, Belgium",
        "KU Leuven Department of Neurosciences, ExpORL, Leuven, Belgium"
      ],
      "name": "Nicolas Verhaert"
    },
    {
      "affiliations": [
        "Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Department of Otorhinolaryngology, Nijmegen, Netherlands"
      ],
      "name": "Wendy Huinck"
    },
    {
      "affiliations": [
        "North Wales Auditory Implant Service, Betsi Cadwaladr University Health Board, Wales, UK"
      ],
      "name": "Jennifer Townsend"
    },
    {
      "affiliations": [
        "Department of Otorhinolaryngology, Ghent University Hospital, C. Heymanslaan 10, Ghent, Belgium"
      ],
      "name": "Freya Swinnen"
    },
    {
      "affiliations": [
        "Department of Otorhinolaryngology, Ghent University Hospital, C. Heymanslaan 10, Ghent, Belgium"
      ],
      "name": "Ingeborg Dhooge"
    },
    {
      "affiliations": [
        "Hearing Implant Centre, Guy's and St Thomas’ NHS Foundation Trust, London, UK"
      ],
      "name": "Anel de Klerk"
    },
    {
      "affiliations": [
        "St George’s University Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "Dhaval Mehta"
    },
    {
      "affiliations": [
        "Section of Otorhinolaryngology, Department of Neuroscience, University of Padova, Padova, Italy"
      ],
      "name": "Davide Brotto"
    },
    {
      "affiliations": [
        "Midlands Hearing Implant Programme (Adult Service), Queen Elizabeth Hospital NHS Foundation Trust, Birmingham, UK"
      ],
      "name": "Louise Craddock"
    },
    {
      "affiliations": [
        "Maastricht University Medical Center, Maastricht, Netherlands"
      ],
      "name": "Gijs Hoskam"
    },
    {
      "affiliations": [
        "Cochlear Limited, Macquarie University, Sydney, New South Wales, Australia"
      ],
      "name": "I Manjula Schou"
    },
    {
      "affiliations": [
        "Cochlear Limited, Macquarie University, Sydney, New South Wales, Australia"
      ],
      "name": "Margaret E McBride"
    },
    {
      "affiliations": [
        "Cochlear Limited, Macquarie University, Sydney, New South Wales, Australia"
      ],
      "name": "Cherith Campbell-Bell"
    }
  ],
  "title": "Randomised controlled trial to assess the efficiency and effectiveness of remote care compared with in-clinic care for adult cochlear implant recipients in the first 12 months after activation: a protocol of the INSPIRE study",
  "uid": "e43615cc-a152-532a-972d-2b1df7f3a76f"
}