36m Follow-up study Information Sheet for WORKWELL Participants
Part One: Introduction
We would like to invite you to take part in a research study. The study is being run by the Centre for Health Sciences Research, University of Salford. Before you decide, you need to understand why the research is being done and what it will involve for you. Please take time to read the following information carefully. Talk to others about the study if you wish. If you have any questions, please contact our Trial Research staff (0161 295 2120 and email@example.com). Please ask if there is anything that is not clear to you or if you would like more information. Take time to decide whether or not you wish to take part.
What is the purpose of this study?
Working people with arthritis may experience difficulties in working due to their arthritis. The Workwell study tested whether practical work advice provided by a Workwell-trained therapist, or written self-help information about work, helped reduce such work difficulties.
In this study, we want to find out if this work advice and information has had any longer-term effects in helping people at work.
Why have I been invited?
We are asking you to take part, because you previously took part in the Workwell study.
Do I have to take part?
It is up to you to decide. Please read this information sheet and contact us if you have any queries. If you decide to take part, you will be free to withdraw at any time, without giving a reason.
What will happen to me if I take part?
We will ask you to complete a short questionnaire (online or postal, whichever you prefer) asking if you are still working and about any work difficulties you may have. It takes about 15-20 minutes to complete. We will send this to you about three-years after you started in the Workwell study with us. The questionnaire is much shorter than those you previously filled in. We will ask you to tick a short consent form on the front of the questionnaire. Returning the completed questionnaire also indicates your consent to take part.
If you choose an online questionnaire, please click on the link in the email we send you to complete and submit your questionnaire. If you choose a postal questionnaire, please return the completed questionnaire in the FREEPOST envelope provided (i.e., at no cost to yourself).
We also would like up to 15 people, who saw a Workwell occupational therapist, to take part in a telephone interview. If you saw a Workwell therapist, we would like to ask about your work, how arthritis is affecting it, and any longer-term effects of receiving work support from the therapist. If you are interested in this, please tick the box on the front page of the questionnaire. (If you are not sure if you saw a therapist, we can check our records). We may have more volunteers than we need. If you do volunteer, we will get in touch within 4 weeks of you returning the questionnaire. We will tell you more about the interview, answer any questions, and ask for your informed consent if you are happy to take part. The interview should last around 30-45 minutes.
We would like to audio-record the interview to help us later in writing down accurately what you said. The recordings are only listened to by our research staff. Your name is not identified when these are typed up. We delete the recordings once the content is written down. We will not ask about any private information. (Please do not disclose such information to the interviewer).
Expenses and payments
There is no expense in completing the questionnaires, as we provide FREEPOST envelopes for the reply. If you are taking part in the telephone interview, we will call you so you will not need to pay for the phone call.
What are the possible benefits of taking part?
The information you give us will help us understand any effects the information pack and WORKWELL programme may have on people with arthritis’ work problems in the longer-term. In future, this will help therapists plan work-related treatment for people with arthritis.
What are the possible disadvantages and risks of taking part?
We do not expect there are any disadvantages or risks to you. If you opt for the telephone interview, we will arrange the call at a time to suit you.
If the information in Part 1 has interested you and you are considering taking part, please read the additional information in Part 2 before making any decision.
Part Two: Further information
Will my taking part in this study be kept confidential?
Yes. We will follow ethical and legal practice. We will handle all information about you in confidence. We will store it securely at the University of Salford. All information which is collected about you during the course of the research will be kept strictly confidential. We only identify you in the interview recording and questionnaire booklet by a study number. You have the right to check the accuracy of the data held and correct any errors. Only staff involved in the research study see your information. Any direct quotes from the audio-recordings we use in reports, will not identify you in any way. If you are taking part in the telephone interview, we will send you a copy of your signed consent form for your records.
How we will use your personal data and your rights under the law.
The University of Salford is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by visiting our website: https://www.workwelluk.org/privacy-notice
The only people in the University of Salford who will have access to information that identifies you will be people who need to contact you to (for example to discuss the study, find out any missing information, arrange an interview) or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details.
Your NHS department will now keep identifiable information about you from this study for 3 years after this 3-year follow-up study has finished. The research team at the University of Salford will also keep identifiable information about you from this study for 6 years after the study has finished. Your information will be stored in locked cabinets and then a data archive store within the Centre for Health Sciences Research and only accessible to members of the research team. After this date, your identifiable information, questionnaires (paper and any scanned information) will be confidentially destroyed or purged from the University server.
What will happen if I don’t want to carry on with the study?
You can withdraw from the study at any time, and your care will not be affected. We will use the data collected up until your withdrawal unless you tell us not to.
What will happen if there is a problem?
If you have any problems with this follow-up study, please contact us to discuss this.
If you have any complaint about the way you have been dealt with during the study, or any possible harm you might suffer, we will address this. If you have a concern about any aspect of this follow-up study, please kindly speak to us first. We will do our best to answer your questions (contact us by email: firstname.lastname@example.org or telephone: 0161 295 2120).
If you remain unhappy and wish to complain formally, you can do this through the School of Health Sciences, University of Salford. Please contact:
Professor Ben Light, Associate Dean of Research and Innovation, by email (email@example.com) or by telephone (0161 295 0159).
What will happen to the results of the research study?
We will send you a summary of the findings when the study is fully completed. When you finish taking part, we will send you a letter saying when this is. We will write up the findings and submit them for publication. This will help Rheumatology and Therapy departments learn from our experiences. You will not be identified in any report or publication. We will send your therapist and their Rheumatology/ Therapy department a summary of the study when it is finished. We will also present the study results at national and international rheumatology conferences.
Who is organizing and funding the research?
The Centre for Health Sciences Research, University of Salford is organizing this trial. We are also working with researchers at the: University of Manchester, University of Lancaster, University of Southampton and Sheffield Hallam University. The study is being funded by research funds held by the University of Salford researchers. The Chief Investigators are Professor Alison Hammond and Dr Yeliz Prior. The Centre for Health Sciences Research, University of Salford is part of the Versus Arthritis/ Medical Research Council’s National Centre for Musculoskeletal Health and Work Research.
Who has reviewed the study?
All research in the NHS is looked at by independent groups of people, called a Research Ethics Committee, to protect your safety, rights, wellbeing and dignity. This study has been reviewed and given favorable opinion by West Midlands-Solihull Research Ethics Committee. The Research Ethics Committee at the University of Salford and University of Central Lancashire have also approved the study.
Further information and contact details
If you have any questions about the study, wish to discuss taking part or have any concerns; please contact the researchers direct at: Tel: 07706198706; email: firstname.lastname@example.org
Trial Manager: Dr Angela Ching
Trial Research Administrator: Dr Jennifer Parker
Chief Investigator: Professor Alison Hammond until December 2022 and then Dr Yeliz Prior from January 2023
Address: Centre for Health Sciences Research, University of Salford, Room L701 Allerton, Frederick Road, Salford, M6 6PU (until December 2022 and then
from January please direct post to Dr Yeliz Prior Frederick Road Campus, Brian Blatchford, Frederick Road, Salford, M6 6PU
Information about the study is also available from our website: www.workwelluk.org
Thank you for considering taking part. Please keep this information sheet. We will ask you to sign a consent form if you agree to take part.