MULTI-MODE PILOT STUDY: Evaluating the Dementia Risk Tool app to aid the management of dementia risk in older adults

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1 We would like to invite you to take part in dementia research MULTI-MODE PILOT STUDY: Evaluating the Dementia Risk Tool app to aid the management of dementia risk in older adults Chief Investigator: Study Manager: Professor Lefkos Middleton Neuroepidemiology and Ageing Research Unit School of Public Health Charing Cross Campus St Dunstan s Road London W6 8RP Miss Dinithi Perera Clinical Research Coordinator Neuroepidemiology and Ageing Research Unit Dementia and Alzheimer s disease (AD) is a growing concern, as the number of people living with dementia is becoming more and more prevalent. With no cure available, the focus is now shifting to finding successful preventative treatments for those at risk of developing dementia and Alzheimer s disease. The Dementia Risk Tool app has been developed by researchers at and their European partners, for the use the general public to establish their own risk of developing dementia, in the hope that prospective preventative treatments can be targeted for those at risk. You are being invited to take part in this pilot study to gather feedback on using a mobile phone app to receive a dementia risk score and guidance on how to lower this risk score. Before you decide whether you want to take part or not, it is important for you to understand what this study is, why it is being developed and what it will involve. Please take time to read the information carefully. Talk to others about the study if you wish. If you have any questions about this study, please contact the study team on or dementia.prevention@imperial.ac.uk 1. Why are you contacting me? You are being invited to take part in this study as you are aged 50 or over, and have expressed an interest in being part of research studies for dementia prevention. 2. What is the study and what is it for? The MULTI-MODE Pilot Study is a research study looking into the possible use of a mobile app called the Dementia Risk Tool, for finding out an individual s risk of developing dementia. We want to know how you would feel about receiving a dementia risk score from a mobile app, and to get your feedback on whether you thought such an app would help motivate you to make lifestyle changes should the app reveal that you are at high risk. MULTIMODE Pilot Trial Participant Information Sheet, dated 28 Nov 2017 version 2 Page 1 of 5

2 This is a pilot study because we plan to use the feedback to further develop the Dementia Risk Tool app. For this reason, we will also ask you about advice or information you would expect, or find useful, from such an app. 3. Can I take part in the study? We are asking men and women aged 50 and over, who do not already have a diagnosis relating to dementia, or know their dementia risk, to complete this questionnaire. You will need to have an Android or Apple mobile device to use the App, and a computer or laptop to complete the questionnaire. Your use of English should be good enough to comfortably use the App in this language. Before participating in the study, we will ask you to confirm that you meet this criteria. If any of the above does not describe you, or if you do not want to take part in this study, you do not need to do anything further. Thank you for taking the time to read this information sheet. 4. How do I take part? To take part in the study, you will be invited to download the Dementia Risk Tool app onto your mobile device, such as a mobile phone or tablet, from either the Google Play Store or Apple Appstore, and test it out. After using the app, you will be invited to complete an online survey to answer a series of questions relating to the Dementia Risk Tool and your thoughts on the app. Before undertaking the questionnaire, please read through this participant information sheet carefully. You are welcome to discuss its content with friends and family. If you have any questions regarding the study, please contact our study team on or dementia.prevention@imperial.ac.uk. If, after reading through this participant information sheet, you are happy to proceed with the study, please refer to your study invitation , which will contain information on how to join the study. You will be asked to confirm that you meet the study s eligibility criteria, that understand the details of the study and that you are willing to take part before you can begin. 5. What is the Dementia Risk Tool? The Dementia Risk Tool is an app which has been developed by researchers in Sweden to help users find out their risk of developing dementia by answering a series of health and lifestyle questions. The app provides the user with a dementia risk score and gives guidance on how to lower this score through possible lifestyle changes. The Dementia Risk Tool does not collect any identifiable information, and any information entered into the app will be anonymous. Users can select not to share any data with the app developers should they wish to. 6. What do I do if I don t want to take part? You are under no obligation to take part in this study. The care that you receive from your health professionals will not be affected. If after reading this information sheet, you do not wish to take part, you do not need to do anything. MULTIMODE Pilot Trial Participant Information Sheet, dated 28 Nov 2017 version 2 Page 2 of 5

3 7. What will I have to do if I agree to join the study? If you decide to take part in the study, you will be invited to download the Dementia Risk Tool app onto your mobile device (such as your mobile phone or tablet) and try it out. After using it, you will be asked to complete an online survey. You will be asked to confirm your agreement to take part before you proceed to answering the survey questions. Once you complete all the questions, and exit the survey, your participation in the study will end. 8. What will happen next? If, after reading this information sheet, you are interested in taking part in the study, please click on the link given at the end of this invitation to proceed in the study. If you have any questions about the study, the app or the survey, please contact the study team on or dementia.prevention@imperial.ac.uk. 9. If I join the study, will I have to travel somewhere? How much time will it take up? If you decide to take part in the study, you can test the app and complete the survey in your own time. You do not need to travel anywhere specific for this this study. It is anticipated that the app will take approx. 5 mins to download and test, and the survey will take approx mins to complete. 10. What are the possible benefits of taking part? We are primarily asking you to provide feedback on an app to help us with development of this. Therefore, we do not anticipate any direct benefit to you. However, we do expect that your contribution will benefit the general public in helping us reach a point where the Dementia Risk Tool app is an effective tool in assisting individuals with managing their risk of developing dementia, and can help to inform health decisions made by individuals and their health professionals. 11. What are the possible disadvantages and risks of taking part? There are no foreseen disadvantages if you decide to take part in the study. However, we do understand that answering questions about your health or receiving information about your dementia risk, may cause you to feel stressed or anxious. Should you have any concerns, you are welcome to discuss the survey with the study team at any stage of the study; they will be able to offer advice and guidance on the study, the Dementia Risk Tool, and on the completion of the survey. 12. Will my taking part in the research study be kept confidential? All information collected about you during the course of the study will be kept strictly confidential. The app and the online survey will not collect any identifiable data from you. Your answers will remain anonymous. Data collected through the study may be shared with researchers at other European institutions, who are partnering in this study, for the purposes of analysis. However all data shared, will be anonymised and will not identify you by name. All sensitive personal information, such as names and contact details, will be kept confidential at Imperial College and will not be shared with any external partners. MULTIMODE Pilot Trial Participant Information Sheet, dated 28 Nov 2017 version 2 Page 3 of 5

4 13. What if I don t want to carry on being involved with the research study? If, after joining the study, you decide that you do not want to continue participating in it, you are able to withdraw from the study at any point. You do not have to give any reasons for your withdrawal and your decision to withdraw will not affect any medical treatments. If you decide to withdraw after starting the survey, any responses that you have provided up to that point will be recorded and used for analysis, but no further data will be collected from you. 14. What if there is a problem? If you experience any problems whilst participating in the study or have any concerns, please speak to the study team on: Tel: If you are not satisfied, you can also contact: Professor Lefkos Middleton l.middleton@imperial.ac.uk As you are asked to test the app and complete the survey in your own time, if you experience any medical occurrence whilst completing the survey, we ask that you report this as soon as possible to the study team on Tel: Will anybody else be informed of my involvement in the study? We will not be informing anyone of your participation in the study. As your responses in the app and on the survey will be anonymous we will be unable to confirm your participation in the study and/or share any details of any responses that you have provided. 16. Who is organising and funding the study? Has it been reviewed independently? This research study is being funded by EIT-Health as part of the MULTIMODE project. The study has been reviewed by the Imperial College Research Ethics Committee. 17. Can I speak to someone if I still have any questions? If you have any questions about the study, please contact the Study Manager on the below details, who will be able to provide further information on the study: Name: Miss Dinithi Perera Phone: MULTIMODE Pilot Trial Participant Information Sheet, dated 28 Nov 2017 version 2 Page 4 of 5

5 Thank you for considering your involvement in this research study and for taking the time to read this information . If you agree to participate in this study, please refer to your study invitation for further instructions on how to join the study. MULTIMODE Pilot Trial Participant Information Sheet, dated 28 Nov 2017 version 2 Page 5 of 5