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Active Brains is a study who are looking to recruit patients who are aged between 60-85 without a diagnosis of dementia.
A quick summary of the study
· This study is testing an interactive programme (called ‘Active Brains’) to help people aged 60-85 with lifestyle changes and brain training activities which may help with memory and thinking skills.
· If you take part, the study will last for five years.
· We ask everyone who takes part to complete 4 online puzzle games and answer some questions about how they are when they start the study, and then again each year after that. Doing these online puzzle games each year is a really important part of the study, and only takes about 10 minutes.
· About two thirds of people will be in a group who can use Active Brains straight away and one third of people will carry on with usual care and get brief advice about a healthy lifestyle.
· Which group you are in will be decided by chance.
· Everyone in the study will carry on receiving their usual NHS care.
· The activities recommended by Active Brains can nearly all be done at home. They are all activities that are likely to be good for staying fit and healthy in general. However, it is very important to follow current government advice about how to stay safe and healthy during the Coronavirus (COVID-19) outbreak.
· Active Brains is not designed to treat the type of memory and thinking problems that can be caused by COVID. If you feel as if your thinking skills are currently being affected by COVID unfortunately this study will not be suitable for you.
· The study is being run by the University of Southampton and is funded by the National Institute for Health Research, the main funder of research in the NHS.
What is the aim of the study?
The aim of the study is to find out if using Active Brains is useful for people aged 60-85 to keep their brain healthy. We want to know if it can help with things like memory, thinking skills, and quality of life.
What will happen if I take part?
If you are in one of the groups who can use Active Brains then you can use it as much as you like. You can choose which bits of Active Brains you would like to see and use. We will record which parts of the website people use in the study.
What are the possible pros and cons of taking part?
Taking part in the study and using Active Brains might improve your memory and thinking skills and general well-being. In our other studies, people have enjoyed taking part and learning new things.
A while after the study has finished we will tell everyone who took part about what the study found out. If Active Brains is shown to be helpful for people’s memory and thinking skills, we will try to make it available for everyone to use. As someone who took part we would let you know how you could access Active Brains.
Taking part in the Active Brains study will take up some of your time. It will take about 30 minutes to fill in the questions about how you are. You will be asked to complete these questions every year.
What will happen if I don’t want to carry on with the study?
You can change your mind and stop taking part in the study any time without giving a reason. This will not affect the medical care you receive in any way. If you decide to stop taking part then the information you have given us up to that point would be used in study results, unless you tell us not to. This information would not include any of your personal details (e.g. your name, or any other details that could let people know who you are).
Will my taking part in this study be kept confidential?
The Active Brains website is secure. Only people on the study team will be able to see your data. We will have your contact details and the ones for your contact person so that we can keep in touch. Your GP will know that you are taking part in the study. After years 1 and 5, relevant parts of your medical records will be checked by the research team. All personal data will be deleted at the end of the study. Once analysis and reporting our results are complete, study data will be archived in a sponsor approved facility for 10 years. After this time all data will be destroyed. The findings from this study will be used in research reports, but no names will be included in the report. Any feedback you give us will be anonymous. You can find out more at www.activebrains.online/page/privacy-policy.
What will happen to the results of the research study?
The results will be presented at medical conferences, published in medical journals, used to educate students and develop the Active Brains programme. None of this will include names or personal details.
Who has reviewed the study?
The study has been reviewed and given approval by Bradford Leeds NHS Research Ethics Committee (Ref 20/YH/0018).
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