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”.
In this study, stroke services will be randomly allocated to either provide the new approach or continue with their “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.
You are being invited take part because you are the relative, friend and / or carer of someone who has had a stroke and is being cared for by a stroke service taking part in our study.
No, it is up to you. You do not have to give a reason if you decide not to take part. If you decide not to take part in this study, the standard of care that you/your relative or friend receives will not be affected in any way, whether you decide to take part in this study or not.
If you would like to take part, we will:
A researcher will ask you some questions about yourself (for example, your age and your relationship to the person who has had a stroke).
You will be asked to complete some questionnaires on four 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 5-15 minutes to complete.
A researcher may also contact you in a few months’ time to take part in an interview so we can gain your views on the treatment and services your relative / friend has received. Not everyone will be contacted. If you are, you can agree or refuse to take part in the interview at that point. 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.
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 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 will use your identifiable information (name, date of birth, address, telephone number and email address) to contact you about the 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 don’t have to give a reason. If you withdraw, the information already collected from you will be included in the final study analysis.
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 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. 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.
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.
More information on how we use your data can be found in our Supplementary Information Sheet for Carers.