Participant Information Sheet
Evaluation of Remote Peer-Mentorship In Osteoarthritis
1. Invitation
We would like to invite you to take part in a research study looking at receiving remote peer-mentorship support for people with hip or knee osteoarthritis who are experiencing socioeconomic disadvantage. This type of support is designed to help people with OA manage their condition and delivered by trained volunteers (called peer mentors) who also have osteoarthritis. Before you decide whether or not to take part in this study, it is important for you to understand why this research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Please contact us using the information at the end of this letter if anything is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
2. What is the purpose of this study?
Osteoarthritis (OA) of the hip and knee are the most common forms of arthritis and often cause joint pain. OA of the hip and/or knee can cause physical disability, reduce mobility, interfere with independence, affect mood, and the ability to take part in social activities. We have developed a programme of support for individuals who have hip and/or knee OA. This support can be delivered remotely by a peer mentor, who is a trained volunteer who also has OA. We want to see whether this type of support, referred to as remote peer-mentorship benefits the people who receive it and in what ways it helps them.
3. Why have I been chosen to take part in this study?
You have been invited to take part because you have osteoarthritis of the hip and/or knee. You have also identified yourself as experiencing socioeconomic disadvantage. This may be due to factors such as your household income, other resources that are available to you; your housing situation or the area you live in.
4. What would taking part in this study involve?
You will be provided with support for your osteoarthritis through receiving remotely delivered weekly mentorship from a trained volunteer. The volunteer known as a ‘peer mentor’ also has osteoarthritis and is experiencing socioeconomic disadvantage. The peer mentor will work with you individually or in a small group (1-2 others) to manage your osteoarthritis more effectively. The peer mentor will connect with you remotely (either through the telephone or by a video call e.g. Teams or Zoom) for up to one hour each week for 6 sessions. The peer mentor will only have access to your name and if required your email address or telephone number. It you don’t have access to video calling, we will loan you a digital device (tablet) with pre-paid internet access. We can also help you learn how to use it, if required.
If you decide to take part in this study, you will be contacted by a member of the research team who can answer any questions you might have, and the researcher will complete a questionnaire with you over the phone. This will take around 15-20 minutes. The questionnaire will ask things like how long you have had your hip or knee OA; what medication you take for OA; about your pain levels and how you manage; how easily you can move about; and your quality of life.
Next the researcher will match you up with a peer mentor and arrange for your mentorship-support sessions to start. This will be at a time and day that works for both of you and arranged by a member of the study team. During these sessions, your peer mentor will listen to your concerns about your OA and help you learn more about it. They will provide information and different types of support that will help you to manage your osteoarthritis. You will receive six peer-mentorship sessions (either individually or in a small group), each lasting about one hour. These are all the peer mentorship sessions you will receive and there is no provision for peer-mentorship to continue after the study has ended. Sessions will usually take place weekly on the same day at the same time depending on your availability. We will also send you information and exercise sheets, in the post or by email. These will help remind you what you and your peer mentor have talked about and help you to self-manage your osteoarthritis. The peer mentor will complete a brief summary of the session, and these will be shared with the research team and anonymised. There will be no provision of the peer mentorship programme after the study has ended.
At the end of your six peer-mentorship sessions, a researcher will contact you and ask whether you would be willing to take part in an interview about your experience of receiving remote peer-mentorship for your osteoarthritis. This interview will be held remotely (either by telephone or video call) and will take around 45 minutes. We will ask your permission to record this interview, either using a digital recording device or if through Zoom or Teams, the built-in video-recording facility. Six months later, we will contact you again to ask if you will take part in another interview. This 30 minute interview will focus on how you have managed your osteoarthritis since the mentorship support ended. You do not have to take part in either of the interviews and you can decide at the time whether or not you wish to participate in just one or both of the interviews.
5. Do I have to take part in this study?
No, you do not have to take part, the decision is entirely up to you. If you decide to take part, you will be free to leave the study at any time and without giving a reason. Your decision about whether to take part in this study, or to leave the study after you have started taking part, will not affect the routine care you receive.
6. What will happen to the findings of this study
We will use the findings of this study to learn more about remote peer-mentorship for osteoarthritis. We will learn how acceptable remote peer-mentorship is for people with hip and knee OA and how it may help with self-management of osteoarthritis. We will share the findings of this study with other people through written reports which will be published in medical and health journals. We will also share our findings at conferences and on social media. We will also produce a report for the funders of this study.
We can also send you a written or pictorial summary of the findings and any journal publications we produce from this study if you would like us to. We will need your consent to do this.
7. What are the possible benefits of taking part in this study?
This research is trying to find out whether remote peer-mentorship for osteoarthritis is of any benefit to people with hip and/or knee osteoarthritis who are experiencing socioeconomic disadvantage. This study involves receiving weekly support sessions from a trained volunteer to support self-management of osteoarthritis. Receiving this type of support may help you learn how to manage your symptoms better. However, you may find that there are no direct benefits to you in taking part in this research.
8. What are the possible disadvantages and risks of taking part in this study?
Taking part in this study does not involve a change to the routine care you receive, therefore there are no direct risks to taking part in this study. You will receive remote (telephone or video call) support (either individually or with one or two others with osteoarthritis) from a trained volunteer mentor who also has osteoarthritis. They will aim to support you to manage your osteoarthritis. If at any time, you wish to stop the peer mentor sessions, contact the study co-ordinator (details below) who will do this on your behalf.
9. What if I have a problem whilst taking part in this study?
If you have a question or concern about any aspect of this study, you should ask to speak with a member of the research team who will do their best to answer your questions and concerns. If you are not satisfied with what the researcher has said, you can ask to speak to the University of Leeds governance team by emailing: governance-ethics@leeds.ac.uk.
Study participants can claim/receive compensation where any harm/injury has resulted from taking part in the study. The University, as Sponsor, has insurance cover in force, which meets claims against it and where those claims arise from the Universities own negligence in its role and activities relating to the study (and which is subject to the terms, conditions and exceptions of the relevant policy).
10. Will my taking part in the study be kept confidential?
Yes. The University of Leeds is the sponsor for this study and will keep personal identifiable information about you for 6-12 months and anonymised data for 5 years after the end the study. This information will then be confidentially destroyed.
How will we use information about you?
We will need to use information from you for this research study. This information will include the personal details you provided These details include: your name, month and year of birth, telephone number and email address. In addition, if you chose to have information sent to your own home, you will be asked to provide your postal address.
People connected with the study will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. The only time we might need to share your personal information outside of the study (break your confidentiality) would be if you indicated you had broken the law, are planning to break the law or are at risk of harming yourself or others.
The audio recordings of the interviews from this study will be transcribed (typed up) by 1st Class Secretarial Services. A Data Processing Agreement will be in place between the University of Leeds and 1st Class Secretarial Services.
We may use direct quotes from your interview in reports, publications, and presentations. However, all quotes will be anonymised. This means no one will be able to identify you from what you have said. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that protects your identity so no-one can work out that you took part in the study.
If you agree to take part in this study, the information you share may be provided to researchers running other research studies at the University of Leeds and other organisations. This information will not identify you and will not be combined with other information in a way that could identify you.
What are your choices about how your information is used?
- You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have collected.
- We need to manage your records in specific ways for the research to be reliable. This means that we are unable to let you see or change the data we hold about you.
Where can you find out more about how your information is used?
You can find out more about how we use your information:
- At www.hra.nhs.uk/information-about-patients/
- At https://dataprotection.leeds.ac.uk/wp-content/uploads/sites/48/2019/02/Research-Privacy-Notice.pdf
- By asking one of the research team
- By sending an email to the University Data Protection Officer via DPO@leeds.ac.uk
11. What do I do now?
If you would like to take part in this study please return the enclosed Contact Form (either by post or online) or email Elizabeth Lavender (Study Co-ordinator) or Amrit Daffu-O’Reilly (Research Fellow) via mskprism@leeds.ac.uk to let a member of the research team know that you are interested in taking part. The return postal and email address are on the Contact Form.
12. Study Contact Information:
If you have any further questions about this study, please contact us using the details below:
Elizabeth Lavender, Study Co-ordinator, School of Healthcare, Baines Wing, University of Leeds, Leeds, LS2 9JT. Email: mskprism@leeds.ac.uk; Tel: 0113 343 1346; Mobile 07745210126
Dr Amrit Daffu-O’Reilly, Research Fellow, School of Healthcare, Baines Wing, University of Leeds, Leeds, LS2 9JT. Email: mskprism@leeds.ac.uk; Tel 0113 3437551; Mobile 07745210126
Professor Gretl McHugh, Professor of Applied Health Research, School of Healthcare Baines Wing, University of Leeds, Leeds, LS2 9JT. Email: G.A.McHugh@leeds.ac.uk; Tel: 0113 343 1365
Thank you for taking time to read this information sheet and to consider taking part in this study.
This project has been funded by Nuffield Foundation’s Oliver Bird Fund and Versus Arthritis (OBF/FR-000023819), but the views expressed are those of the authors and not necessarily funders. Visit www.nuffiedfoundation.org and www.versusarthritis.org.
Please click on 'next' to proceed to the online version of the Contact Form.
