The purpose of this study is to find out whether adding the Stroke Action Falls (SAF) programme to usual care can reduce falls in people who have had a stroke, compared to those receiving usual care alone.

Some patients in this study will receive the Stroke Action Falls programme along with their usual care, while others will receive usual care only. Usual care follows national guidelines and usually includes a combination of medical treatment, rehabilitation, and social support, depending on how serious the stroke was and what each person needs.

You will be asked to complete a few short questionnaires over the 12 months after leaving hospital.

You have been invited to take part in this study because you have had a stroke and will soon be going home from the hospital. A member of your healthcare team will confirm whether this study is suitable for you.

We are inviting 464 people who have recently had a stroke to take part in this research.

Participation in this study is entirely voluntary. It is up to you whether you take part in the study. Even if you agree now, you are free to withdraw later if you wish. We will explain the study to you and answer any questions you may have. If you agree to participate, we will ask you to sign a consent form. If you are unable to sign but can still make your own decisions, a witness can sign the form on your behalf. If you are unable to sign but can still make your own decisions, a witness can sign the form on your behalf. If you are unable to give consent yourself, a personal consultee (such as a family member or close friend) can advise the research team on what they believe your wishes and feelings would be about taking part, and they will sign a declaration form. If you choose not to participate, you will continue to receive the standard care you deserve.

If you decide to take part, your involvement in the study will last for about 12 months. This starts from the time you are randomly placed into a group, until you complete your final questionnaire.

After you have read the patient information sheet and talked with a member of your healthcare team, you will be asked to sign a consent form. We will also ask for some basic details, like your contact information, so we can send you the study questionnaires.

As part of the study, you will be treated as part of the Stroke Action Falls programme plus usual care or in line with usual care alone. The treatment you receive will be decided by a process called randomisation. This means you will be placed into one of the two groups by chance, giving everyone an equal chance of receiving either treatment. Randomisation helps create similar groups, so we can fairly compare them and find out whether adding the Stroke Action Falls programme helps reduce falls in people who have had a stroke.

Neither you, your healthcare team, nor the research team can choose which group you are placed in, as this could make the results less reliable. Everyone in the study will receive the usual stroke aftercare. If you are placed in the group receiving the Stroke Action Falls programme, you will also have an extra home visit from a local Falls lead, who will deliver the programme with you.

Taking part in this study will not require you to attend any extra hospital visits outside of your usual care. Your participation will last for 12 months after you leave the hospital. During this time, we will ask you each month whether you have had any falls, and some details about any falls you have. Every three months, we will also ask you to complete some short questionnaires about your general health.

With your permission, we will let your General Practitioner (GP) know that you are taking part in the study. If you are currently in another stroke-related study or have taken part in one recently, please think carefully about whether joining this study is right for you. If you are unsure, you can talk it through with the research team.

Taking part in the study may not directly benefit you, but the information we gather could help improve care and reduce falls for other people who have a stroke in the future.

There are no risks associated with taking part in this study. You may find some of the topics covered in the questionnaires upsetting. You do not have to answer any questions you do not wish to.

If you have concerns or questions about any aspect of this study, you should ask to speak to the local researchers. Their contact details are at the end of this information sheet.

If any questions remain you can contact the study coordinating centre:

Tel: (0115) 823 1600 & Email: fiss@nottingham.ac.uk   

If you remain unhappy and wish to complain formally, you can do this through the National Health Service (NHS) Complaints Procedure via your local Patient Advisory and Liaison Service (PALS).

If something does go wrong and you are harmed because of taking part in the study, there are no special compensation arrangements in place. However, if the harm is caused by someone's negligence, you may have the right to take legal action and seek compensation, although you might have to pay legal costs. You will still be able to use the normal NHS complaints process if you have any concerns.

You are free to withdraw at any time, without giving any reason, and without your legal rights being affected. If you would like to withdraw, contact your local researchers or Nottingham Clinical Trial Unit (NCTU) Study team and they can organise this for you. If you withdraw, or are withdrawn from the study for any reason, the information collected will not be erased and this information may still be used in the study analysis.

We will need to use information from you, your medical records, and the local research team for this project.

This information will include your initials, name, and contact details. The research team will use this information to carry out the study and to check your records, to make sure 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. For everyone else, your information will be replaced with a code number to protect your privacy.

Your contact details will be used by the research team to get in touch with you by post, email, or phone to help you complete the study questionnaires, send reminders, and share the study results with you if you would like to receive them.

If we are not able to reach you directly, we may contact someone close to you, such as a family member or home carer, to help with completing the questionnaires.

The University of Nottingham is the sponsor of this research and is responsible for protecting your personal information. We will keep your information safe and secure by:

• • • Following data protection laws, including the General Data Protection Regulation (GDPR).

    • Using strict access controls on our computer systems.

    • Deleting your personal data when it is no longer needed, as explained in this information sheet.

    • Keeping your contact details separate from your study data.

    • Once the study is finished, we will keep some of the data so we can check and confirm the results. Any reports we write will not include your name or any details that could identify you. We will keep your study data for up to 7 years. After that, the data will be fully anonymised and either securely stored or destroyed.

You can choose to stop being part of the study at any time, without giving a reason. If you do, we will keep the information we have already collected about you.

If you decide to leave the study, we would like to continue collecting information about your health from central NHS records. If you do not want this to happen, just let us know and we will stop. You also have the right to ask us to remove, change, or delete the data we hold about you for this study. However, in some cases, we may not be able to do this if it would affect the reliability of the research. If that happens, we will explain why we can’t do this.

You can find out more about how we use your information, including the specific mechanism used by us when transferring your personal data out of the UK:

• at www.hra.nhs.uk/patientdataandresearch
• at Clinical, Medical and Human Physiology Research Participant Privacy Notice
• at Data Protection at the Nottingham Clinical Trials Unit
• by asking one of the research team
• by sending an email to fiss@nottingham.ac.uk and to our Data protection officer at: dpo@nottingham.ac.uk
• by calling the Nottingham Clinical Trials Unit on: (0115) 823 1600

The lead investigator for this research is Professor Pip Logan, a Professor in Rehabilitation Research at the University of Nottingham and The University of Queensland and Metro North Health, Australia. The deputy lead investigator for this research is Associate Professor Vicky Booth Associate Professor of Rehabilitation School of Medicine at the University of Nottingham. The FISS is being sponsored by the University of Nottingham and coordinated by the Nottingham Clinical Trials Unit (NCTU). The funding for the study is provided by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme (NIHR HTA Project NIHR158240). FISS NIHR research award All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by a Research Ethics Committee. Patients who have previously been treated for having a stroke have helped us plan and design this study.  Patients’ representatives are also involved in the teams that oversee the running of the study.

Sometimes we get new information about your condition during the study. If this happens your research doctor will tell you about this new information and discuss whether you should continue in the study. If you decide not to continue, your doctor will make sure your care goes on as usual. If you choose to stay in the study, you may be asked to sign a new Informed Consent Form.

When the study ends, your healthcare will continue as usual. If you decide to leave the study early, we will keep and use the information collected up to that point.

At the end of the study, the results will be published in medical journals and shared at conferences. You will not be identified in any reports or publications.

We will also send you a newsletter with a summary of the study findings, unless you tell us you do not want to receive it.

If you would like more information about stroke or support for yourself or someone you care for, please visit:

The Stroke Association – www.stroke.org.uk

They provide expert guidance, support services, and resources that may be helpful during or after your participation in the FISS study.

At every stage of the FISS study, we have worked closely with patients and members of the public known as Patient and Public Involvement (PPI) contributors to shape the design, delivery, and communication of the study. The Stroke Action Falls programme was co-designed by patients, carers, health and social care professionals, and researchers to ensure it meets the real needs of stroke survivors.

A key partner in this study is the Nottingham Stroke Research Partnership Group (NSRPG). This group, which includes stroke survivors, carers, and family members who have real, lived experience of stroke. Their insight ensures our research is practical, relevant, and respectful of lived experience.

The NSRPG involvement is a crucial part of the FISS study. By sharing their lived experience, they guide us in ways that improve outcomes and make research more impactful for stroke survivors like you.

We deeply value the perspectives of everyone involved in the FISS study. Your experiences whether as a participant, carer, or family member are important, and we welcome your feedback at any point in the study.