Florence Feasibility Study

  • Research type

    Research Study

  • Full title

    Feasibility of a randomised controlled trial (RCT) to examine the effectiveness and cost-effectiveness of a text-messaging intervention, to improve hearing aid use for NHS adult audiology patients.

  • IRAS ID

    345347

  • Contact name

    Emma Broome

  • Contact email

    emma.broome1@nottingham.ac.uk

  • Sponsor organisation

    WS Audiology

  • Clinicaltrials.gov Identifier

    NCT07146607

  • Duration of Study in the UK

    1 years, 0 months, 31 days

  • Research summary

    The problem
    In the UK, 12 million people have significant long-term hearing loss. Each year 355,000 adults are fitted with NHS hearing aids at a cost of £131million. Hearing aids help patients by amplifying quiet sounds, however the non and infrequent use of hearing aids by NHS patients is high. Patients tell us they would benefit from additional information when hearing aids are first prescribed.

    The solution
    The NHS-approved telehealth service ‘Florence’ has been shown to help patients self-manage many long-term conditions. However, it has not yet been provided to patients with hearing loss. In this study, Florence will send text-messages to NHS patients when they are first prescribed and fitted with hearing aids. Using established behaviour change techniques, the messages will prepare, inform and support patients when adapting to and using their hearing aids by addressing key barriers to hearing aid use.

    We need to understand if the text-message tool is an acceptable intervention for patients and audiologists. We also need to check whether a large clinical trial to measure all of the benefits to patients and the NHS could be carried out, and if so, how best to design it. This information will help ensure the trial provides high quality evidence and value for money.

    Feasibility study with nested process evaluation
    We will:
    • Undertake a feasibility study with 60 first-time adult hearing aid users from NHS audiology clinics.
    • Check how many patients can take part in the study and how many are needed for the trial.
    • Find out what patients and clinicians think about Florence and the research procedures and the text message tool.
    • Share findings with patients, clinicians, charities and researchers.

    We have involved patients in designing the feasibility study, which should make it easier for future patients to take part in the trial.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    24/EM/0167

  • Date of REC Opinion

    20 Aug 2024

  • REC opinion

    Further Information Favourable Opinion