FAMOUS: Follow-up and monitoring of new users of NHS hearing aids
Research type
Research Study
Full title
Follow-up and structured monitoring for adults offered an NHS hearing aid for the first time (FAMOUS): a cluster randomised controlled trial
IRAS ID
313462
Contact name
Kevin Munro
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
ISRCTN Number
ISRCTN10589817
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Each year in the UK about 355,000 adults are fitted with hearing aids for the first time. We know that hearing aids improve communication and quality of life for adults experiencing hearing loss. However, adjusting to hearing aids can be difficult and many patients may not use their hearing aids as recommended, or at all.
Although there are guidelines in place to support first-time hearing aid patients, the way in which the support is provided can vary between NHS adult hearing clinics, which makes assessing the effectiveness of the current guidelines difficult. We want to find out whether a defined four-step hearing aid follow-up plan is as effective as the current NHS guideline care for hearing aid patients, their families and best value for the NHS.
FAMOUS will recruit a minimum of 23,400 patients from around 36 adult NHS hearing aid clinics in the UK. Each clinic will be randomly allocated to treat patients as per current NHS practice, or FAMOUS enhanced care. All patients seen at a participating hearing clinic during the time the trial is active will all be followed up in the same way. All adult patients who are fitted with hearing aids for the first time will be approached at 12 weeks after fitting, and invited to complete follow-up research questionnaires to help us understand their usage and experience with the hearing aids. Those who consent will also be contacted at 12 months post-hearing aid fitting to complete a further research questionnaire pack. Some patients, audiologists and service managers will be invited to take part in semi-structured interviews as part of a process evaluation.
As well as the research questionnaires, we will use anonymous data from routine clinic records to understand if there is a difference in reported hearing aid use and clinic attendance between the two groups.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0836
Date of REC Opinion
21 Dec 2022
REC opinion
Further Information Favourable Opinion