For ParticipantsWhat is the purpose of the study?
Research has shown that too much time spent sitting (sedentary behaviour) is bad for our health. Changes in the amount of time spent sitting may improve recovery after a stroke. The RECREATE study is exploring a new approach to help people sit less, and is testing whether the new approach is better than “usual care”.
The RECREATE study is exploring a new approach to help people sit less, and performing an initial test to see whether the new approach is better than “usual care” This will enable us to compare the new approach with standard practices.
Stroke survivors have been involved throughout the design of this study, to ensure it is well designed and with people such as yourself in mind.
A researcher will ask you some questions about yourself (e.g., your age, height and weight, whether you live alone) and will measure your blood pressure.
You will be asked to complete some questionnaires on 4 occasions over the next 24 months. The first questionnaires will be provided to you when you first agree to take part in the study. The second, third and fourth questionnaires will be provided to you around 6, 12 and 24 months later. On each occasion these may take approximately 60 minutes to complete.
The questions will be about how you feel, what you are able to do, and use of care services, such as GP or hospital visits. It will help us understand more about your experience and the impact of your stroke over 2 years.
Someone, a friend or relative, can help you fill in the questionnaires but you must think of your own responses. This way your answers will definitely be your own. You will be provided with a pre-paid envelope to return your questionnaire.
You will be asked to wear an activity monitor and complete a sleep diary for nine days on each of the 4 occasions.
The activity monitor is extremely small, slim, and very light. The monitor attaches to your thigh and uses information about the position of the thigh to determine body posture (i.e., sitting/lying, standing and stepping).
A researcher will show you how to attach the monitor and help you to do this. You will be provided with a pre-paid envelope to return the monitor and sleep diary at the end of each monitoring period. (Further information is provided in the activPAL Information Leaflet.)
You will be sent a letter around 12 weeks after you leave hospital and may be asked to answer some questions about your recent experiences.
You will be sent newsletters to keep you updated with the study.
A researcher will access relevant parts of your medical and care records so that we can gain information about the treatment and services being provided to you. We may also collect further health and treatment information from electronic databases (e.g. NHS Digital and the Sentinel Stroke National Audit Programme).
A researcher may telephone you, send you text messages or email you about this study (for example if we do not receive the questionnaires or activity monitor back from you).
A researcher may ask you if they can observe some of the care you are being provided with (for example, therapy treatment) and / or contact you in a few months’ time to ask if you would like to take part in an interview so we can gain your views on the treatment and services you have received. The interview would take place at a time and a location that is convenient for you (probably your own home or via telephone) and take about an hour.
The researcher would contact you separately about this. Not everyone will be observed or contacted for an interview. If you are, you can agree or refuse to take part in the observation or interview at that point.
Being involved is unlikely to benefit you directly. However, it may help improve future services and support for people who have had a stroke.
You may find wearing the activity monitor inconvenient. There is a small chance that it might irritate your skin. 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 decide to participate, the information collected about you will be handled strictly in accordance with the consent that you have given and also the 2018 Data Protection Act.
Members of the RECREATE research team and other authorised personnel will use your identifiable information (name, date of birth, address, telephone number and email address) to contact you about the study; make sure that relevant information about the study is recorded for your care and to oversee the quality of the study.
Your GP will be informed about your involvement in this study. Further information about how the data we collect is used is provided in the supplementary information sheet. Please read this information carefully and discuss it with your relatives and friends if you wish. Our privacy notice is available at: https://www.bradfordhospitals.nhs.uk/privacy-statement/.
Ask a member of the research team if anything is unclear, or if you would like more information.
You are free to withdraw from the study at any time, and do not have to give a reason. If you decide to stop taking part it will not affect the standard of care you receive.
If you withdraw from the study, the data collected from you up to that point will be used in analysing the results of the study. Unless you explicitly ask us not to, we will continue to collect information from your electronic health records.
The results of this study will be published in a report and in academic journals. If you wish to obtain a copy of the report, or a lay summary of our findings, you can request one from the Trial Manager (contact details below) or visit our website using the following address: https://www.bradfordresearch.nhs.uk/our-research-teams/academic-unit-for-ageing-and-stroke-research/our-research/stroke-research/
It is also possible that the results may be presented at conferences and included in updates to clinical guidelines. You will not be identified in any report/publication.
If you need further information or have any concerns about any aspects of the study, please contact Seline Ozer, RECREATE Trial Manager Tel: 01274 383908 / 07870 543073, Email: email@example.com in the first instance.
If you remain concerned and / or would like to discuss the study with someone independent of the research team you can contact the Patient Advice and Liaison Service (PALS) based at the hospital that registered you onto the study.
In the unlikely event that something goes wrong and you are harmed during the research and / or you wish to raise a complaint on how we have handled your personal data, the normal NHS complaints procedures are available to you. Details can be obtained from your hospital or the PALS Service. There are no special compensation arrangements in place for this study.
In addition, you can contact the Stroke Association [0303 3033 100] for confidential advice.
The Chief Investigator of this research is Professor Anne Forster, who is employed by the University of Leeds and is carrying out the study from the Academic Unit for Ageing and Stroke Research at Bradford Teaching Hospitals NHS Foundation Trust.
The University of Leeds Clinical Trials Research Unit (CTRU) and King’s College, London are supporting the co-ordination of the study.
To find out more, visit our Meet the Team page.
The research is funded by the Department of Health (National Institute for Health Research). The sponsor for the research is Bradford Teaching Hospitals NHS Foundation Trust. This study has been reviewed by Yorkshire and The Humber – Bradford Leeds Research Ethics Committee.
If you have a change in circumstances (i.e. move house), please contact Seline Ozer, Tel: 07870 543073 or email: firstname.lastname@example.org and we will update our records.
Who is responsible for my data?
Bradford Teaching Hospitals NHS Foundation Trust (BTHFT) is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as “data controller”. This means that we are responsible for looking after your information and using it properly. The University of Leeds Clinical Trials Research Unit (CTRU) will be supporting us in the co-ordination of this study from its premises at the University of Leeds.
How will my data be used?
This research is in the public interest, which means our results will be used to improve the healthcare of patients in the future. Because of this, if you agree to take part in the study, we will use information about you, including sensitive information about your health and ethnicity.
Members of the research team will use your personal information (name, date of birth, address, telephone number and email address) to contact you about the research study and make sure that relevant information about the study is recorded for your care. Other authorised personnel may contact you to oversee the quality of the study.
Your data may be used in future by the organisations involved in this research for evaluation, teaching and training purposes relating to the provision of NHS care and treatment, and for academic and non-commercial research purposes. If this happens, your personal information will be removed so that no-one will be able to identify you.
Individuals from BTHFT and regulatory organisations may look at the information we have gathered from you and look at your medical records to check the accuracy of the research study.
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. If you take part in study observations and decide to withdraw, we will destroy any observation data collected up to that point, should you request it. To safeguard your rights, we will use the minimum amount of personally identifiable information possible.
You can find out more about how we use your information by contacting the Trial Manager (details below). The research team would be happy to forward any further queries you may have on to the Data Protection Officer.
Will my information be kept confidential?
Yes. If you decide to take part, the information collected about you will be handled strictly in accordance with the consent that you have given and also the Data Protection Act 2018.
You will be allocated a unique study number, which will be used along with your date of birth and initials to identify you instead of your name on all paper and electronic records we create for you.
If you consent to completing study questionnaires, the CTRU will hold a copy of the consent form, which will have your name on it. Your name, address, phone number(s) and email address (if you have one) will also be given to the study team at the CTRU and to authorised members of the research team. This is so that they can contact you about the study when they need to (for example, to send the questionnaires). Information may also be shared with another NHS Provider, for the purposes of data collection and follow-up, including administration of the activPAL.
Your data will be entered onto a secure database held at the CTRU. All access to data and databases will be restricted just to the staff who require access to process and analyse the data.
If you consent to the study observations, a copy of your signed consent form will be held at BTHFT. Data from the observations will be entered onto secure databases held at BTHFT and only accessed by authorised members of the research team.
Will you share any of my information?
We will share identifiable information such as initials, date of birth, gender, NHS Number and post code when requesting information from electronic health records registries (e.g. NHS Digital and the Sentinel Stroke National Audit Programme) to ensure we collect the correct information. This information will include health information, which is regarded as a special category of information. We will use this information to check if you have had any major health events during the course of the study. Information will be securely shared, with these system providers also working in accordance with the Data Protection Act 2018.
It is also possible that the information collected about you may be shared with other research teams to answer new research questions in the future. If this happened, the information would be anonymised so that no-one would be able to identify you from it.
Although the information we collect about you is confidential, should we identify something of concern about your health, or you disclose anything to us, which we feel puts you, or someone else at risk of harm, we may feel it necessary to report this to the appropriate persons. In these circumstances, the researcher would report their concerns to the appropriate clinician in the stroke service or your GP and consider contacting the person responsible for Adult Safeguarding in the NHS Trust, where appropriate. In the event that you were no longer in contact with an NHS stroke service, the researcher would report their concern to the Adult Safeguarding Team in the Social Services for your local area.
How will my information be stored?
BTHFT and the CTRU will be responsible for ensuring that information collected about you is kept safe and secure. Your information will only be accessed by individuals who need to do so in order to do their job. All the data you give us, including identifiable information such as name and date of birth will be securely stored for at least 10 years after the end of the study before being confidentially destroyed.
Where can I find out more about how my information is used?
You can find out more about how we use your information
- at www.hra.nhs.uk/information-about-patients/
- by contacting the Trial Manager by using the contact details below
- Bradford Teaching Hospitals NHS Foundation Trust Privacy Notice is available to read at https://www.bradfordhospitals.nhs.uk/privacy-statement/
What should I do if I need to update my details?
If you have a change in circumstances (i.e. move house), please contact us using the details below and we will update our records.
For more information please contact:
Dr Seline Ozer – RECREATE Trial Manager
Academic Unit for Ageing and Stroke Research
Bradford Institute for Health Research
Bradford Royal Infirmary
Tel: 01274 383908 / 07870 543073
More information on how we use your data can be found in our Supplementary Information Sheet for Stroke Survivors.