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Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial

Cullington, Helen; Kitterick, Pádraig T.; DeBold, Lisa; Weal, Mark; Clarke, Nicholas; Newberry, Eva; Aubert, Lisa

Authors

Helen Cullington

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DR PADRAIG KITTERICK Padraig.Kitterick@nottingham.ac.uk
Associate Professor in Hearing Sciences Translational Hearing Research

Lisa DeBold

Mark Weal

Nicholas Clarke

Eva Newberry

Lisa Aubert



Abstract

Introduction: Many resources are required to provide postoperative care to patients who receive a cochlear implant. The implant service commits to lifetime follow-up. The patient commits to regular adjustment and rehabilitation appointments in the first year and annual follow-up appointments thereafter. Offering remote follow-up may result in more stable hearing, reduced patient travel expense, time and disruption, more empowered patients, greater equality in service delivery and more freedom to optimise the allocation of clinic resources.

Methods and analysis: This will be a two-arm feasibility randomised controlled trial (RCT) involving 60 adults using cochlear implants with at least 6 months device experience in a 6-month clinical trial of remote care. This project will design, implement and evaluate a person-centred long-term follow-up pathway for people using cochlear implants offering a triple approach of remote and self-monitoring, self-adjustment of device and a personalised online support tool for home speech recognition testing, information, self-rehabilitation, advice, equipment training and troubleshooting. The main outcome measure is patient activation. Secondary outcomes are stability and quality of hearing, stability of quality of life, clinic resources, patient and clinician experience, and any adverse events associated with remote care. We will examine the acceptability of remote care to service users and clinicians, the willingness of participants to be randomised, and attrition rates. We will estimate numbers required to plan a fully powered RCT.

Ethics and dissemination: Ethical approval was received from North West—Greater Manchester South Research Ethics Committee (15/NW/0860) and the University of Southampton Research Governance Office (ERGO 15329).

Results: Results will be disseminated in the clinical and scientific communities and also to the patient population via peer-reviewed research publications both online and in print, conference and meeting presentations, posters, newsletter articles, website reports and social media.

Trial registration number: ISRCTN14644286; Pre-results.

Citation

Cullington, H., Kitterick, P. T., DeBold, L., Weal, M., Clarke, N., Newberry, E., & Aubert, L. (in press). Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial. BMJ Open, 6(5), https://doi.org/10.1136/bmjopen-2016-011342

Journal Article Type Article
Acceptance Date Apr 26, 2016
Online Publication Date May 13, 2016
Deposit Date Jan 31, 2017
Publicly Available Date Jan 31, 2017
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 6
Issue 5
Article Number e011342
DOI https://doi.org/10.1136/bmjopen-2016-011342
Public URL http://eprints.nottingham.ac.uk/id/eprint/39251
Publisher URL http://bmjopen.bmj.com/content/6/5/e011342
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0

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2016_BMJOpen_Cullington_etal.pdf (1.1 Mb)
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0





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