Follow-up and monitoring of new users of NHS hearing aids
| ISRCTN | ISRCTN10589817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10589817 |
| IRAS number | 313462 |
| Secondary identifying numbers | IRAS 313462, NIHR131159 |
- Submission date
- 31/08/2022
- Registration date
- 01/09/2022
- Last edited
- 16/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
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 in 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 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.
Who can participate?
FAMOUS will recruit a minimum of 23,400 participants from around 36 NHS hearing service clinics in the UK. These must be adults over 18 years old who are using hearing aids for the first time.
What does the study involve?
Each clinic will be randomly assigned to follow-up hearing aid patients using current NHS guidelines or the FAMOUS four-step support strategy. This means that all patients seen during the time the trial is active at their clinic will all be followed up in the same way. All patients who are fitted with hearing aids will be contacted at 12 weeks and 12 months after fitting, to complete questionnaires to help us understand their usage and experience with the hearing aids.
As well as the patient 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.
What are the possible benefits and risks of participating?
Taking part in the study may not directly benefit the patient, however, the research will help us to understand more about how patients use their hearing aids and improve the care provided in the future. There are no associated risks to patients taking part in this study. There may be some sensitive quality of life questions asked, as part of the 12-week and 12-month questionnaires.
Where is the study run from?
The study is being organised by the Manchester University Hospital NHS Foundation Trust (the Sponsor) and coordinated by the Nottingham Clinical Trials Unit (NCTU) (UK)
When is the study starting and how long is it expected to run for?
January 2022 to December 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
famous@nottingham.ac.uk
Contact information
Principal Investigator
School of Health Sciences
Faculty of Biology, Medicine and Health
A3.11 Ellen Wilkinson Building
University of Manchester
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0001-6543-9098 |
|---|---|
| Phone | +44 161 275 3360 |
| kevin.j.munro@manchester.ac.uk |
Study information
| Study design | Multi-centre two-arm parallel-group cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Follow-up and structured monitoring for adults offered an NHS hearing aid for the first time (FAMOUS): a cluster randomised controlled trial |
| Study acronym | FAMOUS |
| Study hypothesis | To investigate the clinical and cost effectiveness of a 4-step follow-up and monitoring intervention in adults offered hearing aids for the first time, compared to usual care, on self-reported hearing aid use 12 months after initial hearing aid fitting. |
| Ethics approval(s) | Approved 21/12/2022, London - Chelsea Research Ethics Committee (Research Ethics Committee (REC) London Centre, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 104 8029; chelsea.rec@hra.nhs.uk), ref: 22/LO/0836 |
| Condition | Adults who present with hearing difficulties and are offered NHS hearing aid/s for the first time. |
| Intervention | FAMOUS is a multi-centre, two-arm parallel-group Cluster Randomised Controlled Trial (CRCT). During the three-month recruitment phase, the audiology clinic’s trial allocation (usual care or enhanced care) will be adopted as their sole clinical practice for that site. All patients seen in NHS audiology clinics will be treated in line with the clinic’s trial allocation and will be subsequently invited to complete patient-reported outcome measures (PROMs). During the recruitment phase, all patients seen in NHS audiology clinics will be treated in line with the clinic’s trial allocation during a 3-month recruitment period, starting from site green light. The two treatment arms of the trial are as follows: Usual Care: The control group will receive usual care according to local procedures for the hearing aid assessment, prescription, fitting appointment, and follow-up care. For the purposes of the trial, usual care must not include the prescription of any combination device or at-ear sound generator. Usual care must include some level of follow-up according to NICE guidelines, which is usually a face-to-face appointment offered at six-weeks-post-fitting. Enhanced care: Patients randomised to the intervention arm will, in addition to receiving usual care, will receive a follow-up and monitoring behaviour change intervention delivered by their NHS audiologist. At the end of the recruitment phase, sites can revert to the hearing aid follow-up and monitoring that they followed prior to involvement in FAMOUS if they choose to. Sites will continue to provide routine data to the NCTU for 12 months following the completion of the recruitment phase. Patients randomised to the enhanced care arm will, in addition to receiving usual care as described above, receive a follow-up and monitoring behaviour change intervention delivered by their NHS audiologist or delegate. This intervention, designed to increase uptake and use of hearing aids, comprises four steps: 1. At the hearing assessment appointment: Patients, in consultation with their audiologist, will compile a list of situations in which they have difficulty hearing and in which they think a hearing aid might help. This activity is consistent with the widely used and accepted Client Oriented Scale of Improvement (COSI) outcomes measurement. 2. At the hearing aid prescription and fitting appointment: A personalised ‘Hearing Aid User Checklist and Diary’ booklet (based on situations in which the patient has difficulty hearing and in which they think a hearing aid might help) to reinforce where and when hearing aids should be used, and to help integrate them into daily life. 3. Early monitoring of hearing aid use at 7-days after fitting in all patients. 4. Six weeks follow-up after the hearing aid prescription and fitting appointment. In addition to the usual care specified by NICE, audiologists and patients will review the action plans that were made at the fitting appointment and will either reiterate (boost) them or form new plans. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported daily hearing aid use, 12 months after initial hearing aid fitting measured using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’ |
| Secondary outcome measures | 1. Self-reported hours of daily hearing aid use measured 12 weeks after initial hearing aid fitting, using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’ 2. Self-reported hours of daily hearing aid non-use measured 12 weeks and 12 months after initial hearing aid fitting, using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’. Non-use is defined as one hour or less per day. 3. Hearing-related quality-of-life (QoL) measured using IOI-HA survey and HHIE survey at 12 weeks and 12 months post hearing aid fitting 4. Relationships with and QoL of significant others (i.e., partner, family members) measured using SOS-HEAR questionnaire at 12 weeks and 12 months post hearing aid fitting 5. Barriers and facilitators to behaviour change within standard practice e.g., capabilities, opportunities and motivations (mechanisms of impact) measured using COM-B questionnaire at 12 weeks post hearing aid fitting 6. Experiences and acceptability of the FAMOUS enhanced care intervention to service users and service providers (process evaluation) measured using semi-structured interviews with patients, service managers and audiologists after the intervention phase has been completed at the site. 7. Estimate the cost to the NHS and value to society measured using HUI-3, HHIE and CSRI questionnaires at 12 months post hearing aid fitting |
| Overall study start date | 01/01/2022 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10800 |
| Total final enrolment | 11733 |
| Participant inclusion criteria | 1. Adults (≥18 years) 2. Using hearing aids for first time |
| Participant exclusion criteria | 1. Adults offered an auditory implant of any kind 2. Adults offered non-conventional hearing aids e.g., that re-route sound between ears. |
| Recruitment start date | 30/05/2023 |
| Recruitment end date | 07/03/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centre
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor information
Hospital/treatment centre
Cobbett House
Oxford Road
Manchester
M13 9WL
England
United Kingdom
| Phone | +44 1612764125 |
|---|---|
| Research.Sponsor@mft.nhs.uk | |
| Website | https://mft.nhs.uk/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The dissemination of the FAMOUS trial findings (main trial results, SWAT, economic analysis and process evaluation) will be via a publication in the NIHR Journals Library (HTA monograph or threaded publication), publication in peer reviewed journals, presentation at medical conferences and communication of our findings to groups involved in guideline development. The manuscripts will be prepared by the Chief Investigator and Trial Management Group and authorship will be determined by mutual agreement. The Trial Steering Committee and Data Monitoring Committee will be given the opportunity to comment on the manuscripts prior to submission. Any secondary publications and presentations prepared by Investigators must be reviewed by the Chief Investigator and NCTU. Manuscripts must be submitted to either party in a timely fashion and in advance of being submitted for publication, to allow time for review and resolution of any outstanding issues. Authors must acknowledge that the trial was performed with the support of Manchester University NHS Foundation Trust. During the trial, press releases may be issued from NCTU or Sponsor. Presentations or other material prepared by local investigators to publicise the trial must be reviewed by the Chief Investigator and NCTU. No party will be entitled to submit any publicity material without prior approval from NCTU. We will create animated videos that will be translated into 4 key languages explaining the results in clear terms. These videos will be available on the trial and BRC websites and be promoted by Royal National Institute for Deaf People, our PPI group and the BRC, to ensure the results are disseminated as broadly as possible. |
| IPD sharing plan | Anonymised participant data may be shared with researchers external to the trial research team in accordance with the NCTU’s Data Sharing Standard Operating Procedure. All requests for data should be sent to the NCTU to be considered by the NCTU Data Sharing review panel. Participant level data will not be available, as it is not permitted by NHS Digital (and devolved nation equivalents) under the terms and conditions under which NCTU receives the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 16/12/2022 | 14/02/2023 | No | No |
| Protocol file | version 3.0 | 06/04/2023 | 31/05/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 4.0 | 17/01/2024 | 09/05/2024 | No | No |
| Statistical Analysis Plan | version 1.0 | 22/06/2023 | 14/05/2024 | No | No |
| Protocol file | version 5.0 | 20/03/2025 | 16/04/2025 | No | No |
Additional files
Editorial Notes
16/04/2025: The following changes were made to the study record:
1. Protocol file V5.0 uploaded (not peer reviewed).
2. The recruitment end date was changed from 28/02/2025 to 07/03/2025.
3. The overall study end date was changed from 30/04/2025 to 31/12/2026.
4. The target number of participants was changed from 23400 to 10800.
5. Total final enrolment added.
25/10/2024: The recruitment end date was changed from 31/10/2024 to 28/02/2025.
14/05/2024: Statistical analysis plan uploaded.
09/05/2024: The following changes were made to the trial record:
1. Uploaded protocol v4.0 (not peer-reviewed) as an additional file.
2. The recruitment end date was changed from 31/05/2024 to 31/10/2024.
31/05/2023: The following changes were made to the trial record:
1. Protocol file uploaded (not peer reviewed).
2. The recruitment start date has been changed from 01/05/2023 to 30/05/2023.
13/04/2023: The recruitment start date has been changed from 01/04/2023 to 01/05/2023.
14/02/2023: The following changes were made to the trial record:
1. Protocol file uploaded (not peer reviewed).
2. Ethics approval details added.
3. The recruitment start date was changed from 01/02/2023 to 01/04/2023.
4. The target number of participants was changed from 5850 to 23400.
31/08/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
