What is the purpose of the study?
To see whether a structured follow-up and monitoring plan affects hearing aid use in first time hearing aid users, compared to current NHS follow-up.
Why are you being contacted?
You have been contacted because you had a new hearing aid fitted. We are asking all patients fitted with hearing aids at your hearing clinic, to complete questionnaires about how much they are wearing their hearing aid, if at all, and experience with wearing their hearing aids, if at all.
Do you have to continue to take part?
It is up to you whether or not you complete the questionnaires for the next part of the study. Your audiologist or a member of the FAMOUS team can talk to you about the study and answer any questions you may have. If you choose to take part, there will also be another opportunity to answer some more questionnaires approximately one year after your hearing aid fitting, in around nine months’ time. Completing either of these questionnaire packs is optional.
What does taking part involve?
Your hearing clinic was either assigned to the current NHS guidelines follow-up plan, or the new follow-up plan, and has shared your medical data with us relating to your hearing aid assessment, fitting and follow-up appointments.
After using your hearing aid for a few months, we would like to learn about whether you are using your hearing aid or not, and about your hearing aid experience.We would like you to complete some questionnaires that are associated with hearing-related quality of life. The FAMOUS questionnaire pack includes:
- A selection of hearing questionnaires that assess quality of hearing in patients
- Some quality-of-life questionnaires for you and a significant other (this can be a friend or a family member)
- A consent form asking for your permission for us to contact you again after one year of hearing aid use, with some additional questionnaires
- A stamped addressed envelope for you to return the completed questionnaires and consent form back to us. The postage is prepaid so you will not have to pay for posting. You can complete the questionnaires electronically if you prefer, please follow the guidance provided in the booklet
We predict it will take no more than 20 minutes to complete these questionnaires. You don’t need to complete them all at the same time. You can take your time and return the completed questionnaires to us once you have finished. Please try and fill in as many of the questionnaires as possible.
You will receive one reminder telephone call from your audiology clinic about the questionnaire packs they are sending in the post. You will receive the call around the time you receive the questionnaire pack (this may be slightly before, or slightly after). This will give you a chance to ask any questions you might have about what is involved.
If you agree to being contacted, we will send you another questionnaire pack a year after your hearing aid fitting. If you also agree to be contacted for an informal discussion about your hearing aid use, then someone from the study team will contact you to give you more information.
What are the possible benefits of taking part?
Taking part in the study may not directly benefit you, this research will help us to understand more about how patients use their hearing aids and improve the care provided in the future. As a ‘thank you’ for completing the questionnaire pack, you will be sent a £10 Love2Shop voucher each time you complete a questionnaire pack.
What are the possible disadvatages and risks of taking part?
Taking part in the study may not directly benefit you, this research will help us to understand more about how patients use their hearing aids and improve the care provided in the future. As a ‘thank you’ for completing the questionnaire pack, you will be emailed a £10 Love2Shop voucher each time you complete a questionnaire pack. This will be sent either by email or post depending on your preference.
What will happen if you don't want to carry on with this study?
You do not have to complete these questionnaires. You can ignore this request without giving any reason, and without your legal rights being affected. If you do not want to carry on with the study, your clinical care will not be affected in any way. If you decline further participation in the study, the information we have already collected from your audiology clinic in relation to your hearing aid appointments will be kept and may be used in the project analysis. This information has been collected anonymously, therefore we will not be able to identify your data to remove it.
How will information about you be used?
Researchers at the NCTU (part of the University of Nottingham) will need to use information from you and your medical records for this research project. The researchers will use this information to check your records to make sure that the research is being done properly. If you provide us with your consent, the answers you give in the questionnaire packs will be linked to your anonymous medical data we have collected from your hearing aid appointments. If you provide us with consent to contact you again with the 12-month questionnaire pack and/or an informal telephone call, the FAMOUS Study team will use your contact details(name, address, email and contact telephone numbers) to get in touch with you again. Contact details will be kept confidential and destroyed to maintain your privacy, before any analysis takes place.
If you choose to receive text reminders about your questionnaires, your first name and mobile number will be shared with eSendex, our approved text message provider (https://www.esendex.co.uk/). All appropriate security steps are taken to ensure your confidentiality, and protection of your data.
All information about you will be kept safe and secure. Once the study has finished, some of the data will be kept so the results can be checked. Reports will be written in a way so that no-one can work out that you took part in the study.
What happens at the end of the study?
When the FAMOUS study ends, your care will continue to be managed by your hearing clinic. If you decide you do not want to complete the questionnaires we send, we will keep and use the anonymous medical information we have already collected from your hearing aid appointments. At the end of the study the results will be published in scientific medical journals and presented at conferences. You will not be identified in any publication. We will share study results using newsletter and an animated video available on our study website, at the end of the study.
View the information sheet link