Participant Information Sheet

OPTIMISING OUTCOMES FOR INDIVIDUALS WITH ACHILLES TENDON RELATED PAIN – A PILOT STUDY

We would like to invite you to take part in our research study. Before you decide, we would like you to understand why the research is being done and what it would involve for you. Please take time to read the following information carefully. Talk to others about the study if you wish. Please ask us if there is anything that is not clear.

 Background to the study

Having a painful Achilles tendon is fairly common. Recent research suggests how treatment is delivered to individuals may be influential on successful treatment is.  Based on previous work, we think expectations, beliefs and who delivers the treatment may be important.

What is the purpose of the study?

Exploring these factors has yet to be investigated, and in order to do so we have designed this ‘pilot study’ to help us develop a larger study to determine if these factors are important.

Why have I been invited?

You have been invited because you are currently undergoing treatment for a painful Achilles tendon.

Do I have to take part?

No, it is up to you to decide to join the study. You can change your mind at any time and decide not to participate. The treatment and standard of care you receive will not be affected in any way if you decide not to take part now or if you withdraw from the study later. We are happy to answer any questions you may have before deciding whether you wish to take part in this study.

What will I have to do?

You will be asked to complete a survey 3 times. Firstly, before your 3^rd visit to see your physiotherapist, again 6 weeks later and finally 3 months later. We will contact you by email to remind you to take the follow up surveys. You may then be invited to participate in a follow up interview about your experience of your treatment.

Expenses and payments

There are no expenses or payments for your participation.

What are the possible disadvantages and risks of taking part?

The survey will take around 15 minutes to complete each time. There are no anticipated risks associated with your participation

What are the possible benefits of taking part?

There are no direct benefits to you, but we hope the information derived from this study will help improve the future treatment of people with painful Achilles tendons.

What will happen if I don’t want to carry on with the study?

If you withdraw from the study, we will destroy all your identifiable data, but we would like to use the data collected up to your withdrawal.

What if there is a problem?

If you have any concerns about any aspect of this study, please contact the chief investigator, Adrian Mallows. You can do this by email amallows@essex.ac.uk or telephone 01206 873847.  He will do his best to answer your questions, however, if you remain unhappy and wish to provide any feedback, or formally complain, please contact Professor Jo Jackson at the University of Essex by email jo.jackson@essex.ac.uk or by telephone 01206 874230. If you would rather contact someone independent of the study, please contact Ewen Speed, Director of Research, School of Health & Human Sciences by email esspeed@essex.ac.uk or by telephone 01206 872847

Will my taking part in this study be kept confidential?

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The survey will not collect any personally identifiable data, but will ask you for your email address so that you can be reminded to take the follow up surveys and potentially be invited for the follow up interview. All data storage will comply with EU data protection regulation. The data collected are stored on a secure, encrypted website called Qualtrics. The website is password protected with only the chief investigator having access to the survey’s data.

What will happen to the results of the research study?

It is anticipated the results from the study will be published and presented at scientific meetings. There is no formal plan to make the results available to participants, however if you would like to obtain a copy please contact Adrian Mallows using the Contact facility on the homepage or email or telephone number listed below.

 Who is organising and funding the research?

The study is being organised by Adrian Mallows as a part of his PhD at The University of Essex. There is no external funding.

 Who has reviewed the study?

The University of Essex Ethics Committee and the NHS Health Research Authority have both reviewed the study and given approval for the conduct of the research (Ref xxxxx).

Further information and contact details

For further information, please contact Adrian Mallows by email amallows@essex.ac.uk or by telephone 01206 873847.