Participant Information Sheet

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Participant Information Sheet

Research Project: Use of digital technologies by people living with Type 2 Diabetes and depression/anxiety

Research team:

• Peter Bath (University of Sheffield)

• Sophie Bennet (King’s College London)

• Rosie Cooper (University of Oxford)

• Suzanne Duffin (University of Sheffield)

• Parisa Singh (King’s College London)

1. Invitation

We are inviting you to take part in a research project. Before you decide if you would like to take part, it is important for you to understand why the research is being done and what it will involve. Read the following information carefully and discuss it with others if you wish. Ask us if there is anything you don’t understand or if you would like more information. Take time to decide whether or not you want to take part.

2. What is the project’s purpose?

The aim of this study is to find out how people with Type 2 Diabetes and depression/anxiety use digital technologies to support their care. This is part of a larger project looking at digital interventions for people with both Type 2 Diabetes (T2DM) and depression/anxiety and other conditions, to find out how effective these interventions are.

We would like to interview people who live with both Type 2 Diabetes and depression/anxiety, or people with one of these conditions, to help us to understand any issues they face when using digital technologies to support their health and care.

3. Why have I been chosen?

You have been invited because you are part of a group of people living with Type 2 Diabetes and depression/anxiety, and are an adult aged 18+, living in the UK. We are hoping to interview approximately 15 people.

4. Do I have to take part?

No, it is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep (and be asked to sign a consent form) and you can still withdraw at any time. You do not have to give a reason and there will be no negative consequences. Any patient support group which shared the information about the project will not be told whether or not you choose to take part (unless you ask us to refer you back to them for support). If you decide not to take part, you do not have to explain your reasons and it will not affect your legal rights or the support you receive from any patient support group you are part of. You are free to withdraw your consent to participate in the research project at any time, without giving a reason, even after signing the consent form.

If you wish to withdraw from the research, please contact Suzanne Duffin via email (s.duffin@sheffield.ac.uk). Please note that once interviews have been completed and the transcripts have been anonymised it will no longer be possible delete them from the research.

Taking part in this research is voluntary and will not create a legally binding agreement or any form of employment with the University of Sheffield.

5. What will happen to me if I take part? What do I have to do?

If you decide to take part, one of the researchers will discuss the research project with you and ask you to sign a consent form. They will then contact you to arrange an interview. Interviews can be carried out online by secure video link, by telephone, by email, or by post, whichever you prefer. If you would prefer a face-to-face in person interview, it may be possible to arrange this in Sheffield.

There will be one interview, which will last for approximately 30 – 60 minutes.

The researcher will ask you about your experiences of using any digital technologies to manage your Type 2 Diabetes, depression, or anxiety. If you do not use any digital technologies, the researcher will ask you about any barriers and challenges to using technology that you experience. If there are any questions in the interview that you do not wish to answer, you can let the researcher know and this will be respected.

The interview will be arranged at a time to suit you between May 2025 to September 2025. If you choose to be interviewed via online video link, you will require an internet connection and access to a device (e.g. smartphone or computer) capable of connecting online to Google Meets for a video call. The researcher will arrange the video meeting and provide access to you for the meeting.

6. Will I be recorded, and how will the recorded media be used?

Interviews will be audio recorded to ensure that a transcript of the interview can be faithfully and accurately reproduced. The audio recordings of the interviews made during this research will be used only for analysis. No other use will be made of them, and no one outside the project will be allowed access to the original recordings. The recordings will be deleted when the project has finished.

7. What are the possible disadvantages and risks of taking part?

It is possible that reflecting on or discussing your experiences of Type 2 Diabetes and anxiety or depression may be upsetting. If this happens, the researcher can signpost you to support organisations, which may include:

• Mind (https://www.mind.org.uk )

• Centre for Mental Health UK – a list of helplines and crisis contacts (https://www.centreformentalhealth.org.uk/helplines-and-crisis-contacts)

• Diabetes UK (https://www.diabetes.org.uk/ )

• Diabetes.co.uk (https://www.diabetes.co.uk/ )

If you become distressed at any point you will be asked if you wish to continue with the interview or end your participation in the project or interview, with no negative consequences to you.

8. What are the possible benefits of taking part?

Participants will be compensated for their time with a Love2Shop voucher to the value of £25. We also hope that this work will help us to understand how effective digital health technologies are, and any issues people face when using them. Your participation will help to improve services for supporting people living with Type 2 Diabetes and anxiety/depression in the future.

9. Will my taking part in this project be kept confidential?

Yes. All information collected from (or about) you during the research project will be kept strictly confidential and will only be accessible to members of the research team. Any personal information you provide will be managed in accordance with data protection legislation.

In exceptional circumstances, the research team may over-ride confidentiality if they feel they have a legal and/or professional obligation to do so, for example if they have reason to believe that there is a risk to your safety, or the safety of others. If this does happen, where appropriate, the research team will aim to notify you of the need to over-ride confidentiality.

10. Data Protection

The University of Sheffield will act as the Data Controller for this study. This means that the University of Sheffield is responsible for looking after your information and using it properly and in accordance with Data Protection legislation. Further information about Data Protection, including your rights, the legal basis under which University of Sheffield processes your personal data for research, University of Sheffield’s Data Protection Policy, how to contact the University of Sheffield Data Protection Officer and how to contact the Information Commissioner’s Office may be found at: https://www.sheffield.ac.uk/govern/data-protection/privacy/general#Complaints%20to%20ICO

Some of your data collected during the research is defined in the legislation as more sensitive (information about your health), so we need to let you know that the use of this data is necessary ‘in the public interest, scientific research purposes or statistical purposes', in accordance with data protection legislation. Further information can be found in the University’s Privacy Notice.

All correspondence will take place through a password protected University of Sheffield email account. The researcher will collect your name, contact details, gender and age as part of the recruitment process (including your name and contact details on the consent form), and allocate you a participant ID number under which your data will later be anonymised. Completed consent forms will be stored on the University of Sheffield secure electronic storage, and deleted from any other devices following transfer. The audio recordings of interviews will be uploaded onto the University of Sheffield’s secure media storage system following each interview, and deleted from any other devices following transfer. Audio recordings will be transcribed verbatim and anonymised with pseudonyms (including for place names and the names of other people) by the researcher as soon as possible.

If you choose to withdraw from the project at any point before anonymisation, you can also request that your stored data be deleted and we will do this if possible. Once data has been anonymised, it will no longer be possible to delete it.

Data will be stored securely for two years after the project is completed and will then be permanently destroyed.

11. What happens to the results of the research?

The results of the project will be written up and put into a report which will be available to participants and to the patient support groups in 2025-2026. The research team also hope to publish these findings in academic journals.

You will not be identified in any publication, report or presentation of this research, and any quotations from your interview will be anonymised.

12. Who is organising and funding the research?

The research is funded by the National Institute for Health and Care Research (NIHR), grant number NIHR R/186813.

13. Who has ethically reviewed the project?

This project has been ethically approved by the School of Information, Journalism and Communication at the University of Sheffield

14. What if something goes wrong and I wish to complain about the research or report a concern or incident?

If you would like to complain about any aspect of the research or if you feel that you have been exploited, abused or harmed as a result of taking part in the research, please contact Professor Peter Bath (p.a.bath@sheffield.ac.uk). If you feel your complaint has not been handled in a satisfactory way you can contact the Head of the School of Information, Journalism and Communication (Professor Brioni Birdi, b.birdi@sheffield.ac.uk). If your complaint is about how your personal data has been handled, you can find information about how to raise a complaint in the University’s Privacy Notice.

15. Contact for further information

If you would like more information about the project, please contact Dr Suzanne Duffin (s.duffin@sheffield.ac.uk); Dr Sophie Bennett (sophie.3.bennett@kcl.ac.uk); or Prof. Peter Bath (p.a.bath@sheffield.ac.uk).

Thank you for considering taking part in this research project. If you decide to participate, you will be given a copy of this information and your signed consent form to keep for your records.

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