Survey information page

INFORMATION SHEET FOR PARTICIPANTS

Understanding vocational needs post COVID-19 and multiple sclerosis

Chief Investigator: Professor Richard Morriss, School of Medicine, Division of Psychiatry and Applied Psychology.

We would like to invite you to take part in a study on vocational and functional recovery after COVID-19 and multiple sclerosis. Before you decide, we would like you to understand why the research is being done and what it would involve for you. One of our team will go through the information sheet with you and answer any questions you may have. Talk to others if you wish. Ask us if there is anything that is not clear.

What is the purpose of the study?

COVID-19 is an infectious disease targeting the respiratory system which has caused a worldwide pandemic. The few months following the first recoveries gave rise to issues linked to patients struggling to return to their normal life after recovery with some patients who were hospitalised with COVID-19 developing a post-COVID-19 syndrome that is not resolving after several months. Notably, these patients are struggling to return to work as they feel too unwell. The aim of the study is to understand the characteristics of this syndrome in order to tailor an intervention to these patients to rehabilitate them back to work. As such, we would like to compare COVID-19 patients to patients with multiple sclerosis because they are both illnesses from which patients make a gradual recovery - and to participants who have had neither multiple sclerosis nor COVID-19.

Why have I been invited?

You have been invited because:
-of your recent diagnosis of COVID-19 or multiple sclerosis and have struggled to return to work since recovery.

OR

-you are willing to take part in the study as a healthy volunteer.

What are the possible benefits of taking part?

Upon survey completion, you will be offered the opportunity to be entered into a prize draw to win one of the two £50 vouchers. The draw will take place on 01/12/2021 and the winner will be informed by email by 03/12/2021.
Those who also take part in the telephone assessment and interview will receive a £15 reward for your participation in the study.

What are the possible disadvantages and risks of taking part?

Some of the questions we will be asking will enquire about symptoms including emotions such as feeling anxious or low. Whilst most people do not mind answering these questions, some may feel upset. It is important that we ask these questions to understand the challenges that the participants face and find out if an intervention can improve these symptoms. Many people find that talking or sharing concerns can be helpful.

Do I have to take part?

It is up to you to decide whether or not to join this study. A researcher will describe the study and go through this information sheet. If you agree to take part, we will ask you to sign an online consent form of which a copy will be emailed to you. You are free to withdraw at any time, without giving a reason. If you withdraw then the information collected so far cannot be erased and this information may still be used in the data analysis.

What will happen to me if I take part?

If you consent to participate, you will be emailed a link to the survey whereby you will fill in a questionnaire by ticking boxes that most apply to you. The questions relate to your physical and mental health. The full questionnaire should take about 30 minutes to fill in. Participants from the COVID-19 and multiple sclerosis groups will receive a second survey link 16 weeks after consent. You will receive a reminder email to complete the survey three and six days after receiving the survey link if you have not done so.

You will be asked whether you consent to being contacted for further assessment, which will be in the format of a telephone questionnaire lasting about 30 minutes and a recorded interview to discuss your symptoms and how they affect you. Should you consent to be contacted, you will be asked you provide your phone number so that we can contact you. You can refuse to answer any questions you feel uncomfortable with and you can stop the interview at any time without giving reason. The researcher phoning you will provide more information about the recorded interview, give you an opportunity to ask more questions and will ask for a recorded consent before starting. The telephone assessment and interview can be split in different sessions and you will have the opportunity to take breaks part way through should you wish to. Ideally, they will be completed within a week of completing the online survey.

Involvement of the General Practitioner/Family Doctor (GP)/other health care practitioners.

If you are found to be at risk to yourself or others, you will be referred by the research team to the local 24 hour crisis team in secondary mental health services or if you are in poor physical health to the local accident and emergency department. The research team will also inform your GP or Psychiatrist.

Expenses and payments

You will be reimbursed any expenses occurred as a result of the participation in this study (for example, the purchase of data for mobile video-conferencing).

What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions. The researchers' contact details are given at the end of this information page.

If you wish to contact someone who is not involved in assessment in the research team, you can contact:
Professor Richard Morriss, Richard.morriss@nottingham.ac.uk,

If you remain unhappy and wish to complain formally, you should then contact the FMHS Research Ethics Committee Administrator E-mail: FMHS-ResearchEthics@nottingham.ac.ukEmail: fmhs-researchethics@nottingham.ac.uk

Will my participation in the study be kept confidential?

We will follow ethical and legal practice and all information about you will be handled in confidence.
If you join the study, we will use information collected from you during the course of the research. This information will be kept strictly confidential, stored in a secure and locked office, and on a password protected database at the University of Nottingham. Under UK Data Protection laws the University is the Data Controller (legally responsible for the data security) and the Chief Investigator of this study (named below) is the Data Custodian (manages access to the data). This means 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 to comply with certain laws and for the research to be reliable and accurate. To safeguard your rights we will use the minimum personally - identifiable information possible.
You can find out more about how we use your information and to read our privacy notice at: https://www.nottingham.ac.uk/utilities/privacy.aspx
The data collected for the study will be looked at and stored by authorised persons from the University of Nottingham who are organising the research. They may also be looked at by authorised people from regulatory organisations to check that the study is being carried out correctly. The research team will not access medical records or extract any data from them, access to medical records by the sponsor may be required for auditing/monitoring purposes. All will have a duty of confidentiality to you as a research participant and we will do our best to meet this duty. Your contact information will be kept by the University of Nottingham for 12 months after the end of the study so that we are able to contact you about the findings of the study and possible follow-up studies(unless you advise us that you do not wish to be contacted). This information will be kept separately from the research data collected and only those who need to will have access to it.
All other data (research data) will be kept securely for 7 years. After this time your data will be disposed of securely. During this time all precautions will be taken by all those involved to maintain your confidentiality, only members of the research team given permission by the data custodian will have access to your personal data.
In accordance with the University of Nottingham's, the Government's and our funders' policies we may share our research data with researchers in other Universities and organisations, including those in other countries, for research in health and social care. Sharing research data is important to allow peer scrutiny, re-use (and therefore avoiding duplication of research) and to understand the bigger picture in particular areas of research. Data sharing in this way is usually anonymised (so that you could not be identified) but if we need to share identifiable information, we will seek your consent for this and ensure it is secure. You will be made aware then if the data is to be shared with countries whose data protection laws differ to those of the UK and how we will protect your confidentiality.
The only time that we would break confidentiality and inform your GP is if we felt that we need to share information to protect your safety or the safety of others or if there is an indication that an alternative form of treatment may be more appropriate for you. We will tell you if we do this

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

Your participation is voluntary, and you are free to withdraw at any time, without giving any reason, and without your legal rights being affected.

If you withdraw then the information collected so far cannot be erased and this information may still be used in the data analysis as we are not allowed to tamper with study records and this information may have already been used in some analyses and may still be used in the final study analyses.

What will happen to the results of the research study?

A summary of results from the study will sent to everyone who participates and the results will be published in peer-reviewed academic journals. You may request copies of any published articles related to this study. You will not be identified in any report or publication.

Who is funding the research?

The research study is being organised by the University of Nottingham and the Applied Research Collaboration (ARC) East Midlands and funded by Santander bank who kindly donated to research the mental health and well-being consequences of COVID-19.

Who has reviewed the study?

We also developed the project with patient and public involvement and engagement (PPI/E) representatives.

Further information and contact details

Please contact
Thank you very much for considering taking part in our study. If you have any queries or would like to talk more about the study, you can contact:
Clem Boutry, Research assistant
Tel: 07929 852207
Email: clem.boutry@nottingham.ac.uk

Chief investigator
Richard Morriss
Email: richard.morriss@nottingham.ac.uk

Principal investigator
Nikos Evangelou
Email: nikos.evangelou@nottingham.ac.uk

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