Participant Information Sheet

Study Title:Remote care of cochlear implant users

Researcher:Helen Cullington

Ethics references:ERGO 15329, IRAS project ID 185061

Please read this information carefully before deciding to take part in this research. If you are happy to participate you will be asked to sign a consent form.

What is the research about?

This is a research project funded by The Health Foundation. We are looking at whether some parts of long-term cochlear implant care could be done remotely by patients themselves at home, instead of coming in to the clinic.

Why have I been invited?

You have been invitedbecause you are an adult who has been using a cochlear implantfor at least 6 months.

What does the project involve?

The people who choose to do the project will be split into two groups:

Group 1 will follow their usual care pathway and still attend appointments at the clinic if needed

Group 2 will be enrolled on the remote care pathway and will have some new tools to use to care for their hearing with the cochlear implant

If you choose to take part in the project, you will be put into one of the groups at random; this means that you and I cannot choose which group you are in.

Whichever group you are in, you can still attend the clinic if you want or need to, and you can choose to leave the project at any time for any reason.

What exactly will happen to me if I take part?

If you want to take part, you will come to two study appointments in Southampton: one in November2015 and the other in summer 2016. Travel expenses will be paid both times and you can have a parking permit if you wish to drive. At the first visit you will find out if you are in Group 1 or Group 2. Please note that if you are not a Southampton patient, we will let your own centre know that you are taking part. You would need to bring your speech processor remote control if you have one, and your direct connect lead or wireless accessory if you have one.

When you come to the first study visit, you will be asked to sign a consent form. You will then have the following tests:

  • listening to sentences and numbers in quiet and noise, similar to what you usually do in clinic
  • questionnaires about how confident you are to look after your health and cochlear implant
  • questionnaires about any hearing difficulties you are having (you may have done one of these questionnaires before, as we send it to patients every year routinely)
  • a questionnaire about your quality of life

The same tests will be done again in summer 2016. In between these two visits, we will collect the following information about you:

•how many times you come to USAIS and why

•how many times you contact USAIS and why

•repairs you need

•age

•gender

•home postcode (to calculate distance to clinic)

•cochlear implant device and speech processor

•your highest formal educational qualifications (egO’levels, degree – this is so we know whether remote care works for all people)

•which cochlear implant centre takes care of you now

If you are in Group 1:

You will not need to do anything else.

If you are in Group 2:

On the day of the first study visit, you will be trained in the new remote care tools. These are:

  1. Self testing

We will show you how you can test your hearing at home using a new website or app. It involves listening to numbers in background noise and typing in the numbers you hear.

If you use certain Cochlear devices, you may be given the ability to check your own impedances (checking the electrodes - like we do in clinic). This would be done on your Cochlear remote control.

  1. Self tuning

If you use certain Cochlear devices, you may be given the ability to make changes to your maps (tuning/mapping - like we do in clinic). This would be done on your Cochlear remote control.

  1. Apersonalised online or smartphone support tool

You will be given a login for a support tool that you can use on a computer or smartphone. This will allow you to manage your own hearing care at home, for example getting information, troubleshooting, learning about your device, learning about music, setting up reminders and setting goals for your hearing.

You can use these remote care tools at any time, as many times as you want, wherever you are. However we would like you to use them at least in the first and 6th month of the project.

You will of course always be able to contact the clinic or come into the clinic as usual at any time you feel it is necessary. These tools are designed to help you, not to stop you coming to clinic.

When you come back for the second study visit in summer 2016, we would also like you to take part in a focus group to find out what you thought about the remote care measures and how they could be improved. We will audio record the focus group. We will ask you if you would be willing to be video recorded talking about what remote care means to you; this would then be used in presentations to describe the research. Your name would not be used. You do not have to do the video recording.

Are there any benefits in my taking part?

There may not be any direct benefits to you if you take part. However it may enable us to improve our service to cochlear implant patients in the future. If you are in the remote care group you may enjoy using the new tools and find them useful for monitoring your hearing. If you are in the control group, we will make sure you are among the first people to get remote care tools if you want them, if and when they become routine.

Are there any risks involved?

There are no significantrisks involved in this experiment.Noise levels will be in accordance with Exposure to Noise at Work act (2005) and the ISVR human experiment guidelines(1996) and therefore will not exceed levels heard on a daily basis. If you are using a Cochlear remote control to adjust your map, we will show you how to stop the test if you feel it is getting too loud. If you wish to stop the project at any point, just let me know. You don’t have to say why.

Will my participation be confidential?

Information collected about you (number of nature of clinic visits, number and nature of clinic contacts, repair logs, age, gender, distance to clinic, cochlear implant device and speech processor, study results and any clinic testing results) during your participation in this study will be kept on a password-protected computer and only be used for the purpose of this research. You will be given a unique identifier (a code) when you join the study, for example CIRCA001. We will store your results using only this code – not your name. The list of who is each code name will be kept in a password-protected computer file separate from the study results and destroyed one year after the experiment ends. The data of the research will be kept for at least 10 years and will be used for presentations, articles and publications around the world. Your name will not be used at any point. We may publish quotes that you say about the project or remote care; we will never use your name.

We will keep track of how much you use the online support tool (e.g. how often you log in, what parts you look at, how long you look at it for). We will not be able to access any other information on your computer. You may choose to set up reminders to come by text message (eg Remember to change your microphone cover).

The research data will also be shared with Insignia – the company who own one of the questionnaires. They will not have access to your name or contact details.

You can have a summary of the findings; please ask Helen Cullington (023 80 597606, ).

What happens if I change my mind?

It is totally up to you whether you take part or not. Whether you take part or not will not affect your clinical care at this centre or your own centre in any way. You are free to withdraw at any point without telling me why.

What happens if something goes wrong?

In the unlikely case of concern or complaint, you should contact the Research Governance Office:

Research Governance Office

George Thomas Building 37

Room 4079

University of Southampton

Highfield

Southampton SO17 1BJ

Tel: 02380 595058

Please note that the researcher or others persons involved in the study will not deal with any complaints.

Who has reviewed this study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given a favourable opinion by the North West – Greater Manchester South Research Ethics Committee.

Where can I get more information?

You can contact:

Dr Helen Cullington (Research Coordinator, University of Southampton Auditory Implant Service)

023 80 597606

You could also contact the Chair of the Remote Care Steering Group, Carl Verschuur:

Dr Carl Verschuur, Director,University of Southampton Auditory Implant Service

023 80 593989

1

Helen Cullington October 15 2015

V 1.0, ERGO ref 15329; IRAS ref 185061