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Randomised controlled feasibility trial of the Active Communication Education programme plus hearing aid provision versus hearing aid provision alone (ACE to HEAR): a study protocol
  1. Nicholas J Thyer1,
  2. Jude Watson2,
  3. Cath Jackson3,
  4. Louise Hickson4,
  5. Christina Maynard1,
  6. Anne Forster5,
  7. Laura Clark2,
  8. Kerry Bell2,
  9. Caroline Fairhurst2,
  10. Kim Cocks2,
  11. Rob Gardner6,
  12. Kate Iley7,
  13. Lorraine Gailey8
  1. 1 Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM), University of Leeds, Leeds, UK
  2. 2 York Trials Unit, Department of Health Sciences, University of York, York, UK
  3. 3 Valid Research Ltd, Wetherby, UK
  4. 4 School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia
  5. 5 Leeds Institute of Health Sciences (LIHS), University of Leeds, Leeds, UK
  6. 6 Audiology Department, Bradford Royal Infirmary, Bradford, UK
  7. 7 Audiology Department, York Hospital, York, UK
  8. 8 Hearing Link, Eastbourne, UK
  1. Correspondence to Dr Nicholas J Thyer; n.j.thyer{at}leeds.ac.uk

Abstract

Introduction Up to 30% of hearing aids fitted to new adult clients are reported to be of low benefit and used intermittently or not at all. Evidence suggests that additional interventions paired with service-delivery redesign may help improve hearing aid use and benefit. The range of interventions available is limited. In particular, the efficacy of interventions like the Active Communication Education (ACE) programme that focus on improving communication success with hearing-impaired people and significant others, has not previously been assessed. We propose that improved communication outcomes associated with the ACE intervention, lead to an increased perception of hearing aid value and more realistic expectations associated with hearing aid use and ownership, which are reported to be key barriers and facilitators for successful hearing aid use. This study will assess the feasibility of delivering ACE and undertaking a definitive randomised controlled trial to evaluate whether ACE would be a cost-effective and acceptable way of increasing quality of life through improving communication and hearing aid use in a public health service such as the National Health Service.

Methods and analysis This will be a randomised controlled, open feasibility trial with embedded economic and process evaluations delivered in audiology departments in two UK cities. We aim to recruit 84 patients (and up to 84 significant others) aged 18 years and over, who report moderate or less than moderate benefit from their new hearing aid. The feasibility of a large-scale study and the acceptability of the ACE intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews.

Ethics and dissemination Ethical approval granted by South East Coast-Surrey Research Ethics Committee (16/LO/2012). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters, patient forums and Trust bulletins.

Trial registration number ISRCTN28090877.

  • hearing loss
  • active communication education
  • hearing aid benefit
  • economic benefit
  • communication benefit
  • hearing aid use

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors NJT led on the conception, design and writing of the study and study protocol with substantial contributions to the design, writing, critical review of intellectual content and final manuscript approval from JW, CJ, KC, AF, LH, LC, KB, CF, CM,RG, KI and LG. All authors agree to be accountable for their work. As Principle Investigator, NJT takes overall responsibility for the work. KC provided statistical expertise in the study design and development stages of the project and the protocol. CF provided further essential statistical advice and expertise on the study protocol. JW, CJ and LC made substantial contributions to the trial design and management. AF was involved in all aspects of the study and LG provided particular input to PPI. KB was specifically responsible for the health economic aspects of the study design and KI and RG were responsible for aspects specific to Trust’s service delivery, providing expert clinical support.

  • Funding Sponsored by Bradford Teaching Hospitals NHS Foundation Trust are the sponsors on behalf of the funder, who is the NIHR as stated below. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for PatientBenefit (RfPB) Programme (Grant Reference Number PB-PG-0215-36147).

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Ethical approval has been granted by South East Coast-Surrey Research Ethics Committee. IRAS project ID 204072 (rec reference 16/LO/2012) and HRA approval obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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