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MPower v1.3 Luxembourg Pilot English Sage Bionetworks May 2016 1.

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Presentation on theme: "MPower v1.3 Luxembourg Pilot English Sage Bionetworks May 2016 1."— Presentation transcript:

1 mPower v1.3 Luxembourg Pilot English Sage Bionetworks May 2016 1

2 2 Branding using v1.3 look/feel No emailing of Consent document- Could be replaced by “view Consent document

3 3 About This Study How can we better manage the symptoms of Parkinson’s disease (PD) together? You can help us understand the fluctuations of PD symptoms and ultimately improve the quality of life for people with PD. Whether you have PD, are touched by someone who has or has had PD or you want to help, we would love for you to participate in this study. We at Sage Bionetworks, a nonprofit biomedical research organization, want to understand why some people with PD have different symptoms than other people with PD, why a person’s symptoms and side effects can vary over time and what can be done to help manage these symptoms. Through surveys and phone sensor data, we can collect and track health and PD symptoms like dexterity, balance or gait. By participating in this study you will help us learn the range of PD symptoms and find out whether mobile devices can help measure PD progression and manage these symptoms better. In this unique study, you will be a research partner. If you are over 18 years old, we invite you to join the study and make a difference in the lives of people affected by PD. mPower is a research study and does not provide medical advice, diagnosis or treatment

4 Information material accessible on the app -What is involved -Who is conducting the study -Links to reference/regulatory documents -Short video or animation about the study Study name

5 5 How this study Works This study will ask you to: 1.Sign up for an account 2.Answer questions about your health 3.Complete simple activities, like walking or tapping on the screen 4.Provide data The study is designed for persons over 18 years old with or without Parkinson Disease 1. Sign up for an Account To sign up for an account you must first complete a consent process explaining the risks and benefits of the study and confirm your agreement to participate in this study. Afterward we will ask you to create an account based on a participant ID provided by the Parkinson Research Clinic in Luxembourg. No personally identifiable information will be submitted in this process. and verify your email address and other general information about you. 2. Complete Health Surveys We will ask you to answer questions about yourself, your medical history, and your current health. We will ask if you have Parkinson disease and if you take certain medications. In addition we will ask you daily, weekly and monthly questions about your symptoms. Because the purpose of this study is to look for patterns over time, we will ask you to review and update your answers from time to time. We might also ask new questions about your mood or how well you slept. These questions are important for the research study. 3. Complete simple Activities We will ask you to do simple activities while holding or using your mobile. For example: Say “aaah” for 10 seconds into your Phone to record variations in your voice Walk back and forth for 30 seconds or stand still with your phone in your pocket to assess your gait and balance. Tap on the phone screen repeatedly to test your motor speed and coordination. Play a short pattern game to assess your short-term memory. Hold your phone for 10-15 seconds to measure tremor in your hand. These activities should take about 20 minutes a day. You may choose to act at your convenience, participate in all or only in some parts of the study. You can enable notifications from the app to receive reminders to do these surveys and activities.

6 6 Who Is Running This Study? STUDY TITLE: mPower (Mobile Parkinson Observatory for Worldwide, Evidence-based research) PROTOCOL NO. 201410711 SPONSOR: Sage Bionetworks (nonprofit) 1100 Fairview Ave. North Seattle, Washington 98109-4433 United States INVESTIGATORS: Prof. Dr. Rejko Krüger (in Luxembourg) Dr. Stephen Friend (in the US) Questions and contact information If you have questions at any time before, during, or after the study, you can contact the study team in Luxembourg by phone at +352 44 11 4848 or email at parkinson@chl.lu or the study sponsor in the US by phone at +1-206-667-2129 (toll free at +1-844-822-4708) or email at PDAppLu@sagebase.org+352 44 11 4848parkinson@chl.luPDAppLu@sagebase.org For questions, comments or requests regarding the privacy policy or our processing of your information, please contact: privacypolicy@sagebase.org Independent Contact: If you are not satisfied with how this study is being conducted, if you have questions about your rights as a research participant or if you have questions, concerns, input, or complaints about the research, please contact the Western Institutional Review Board i(WIRB) in the US to speak to someone independent of the research team: Western Institutional Review Board® (WIRB®) 1019 39th Avenue SE Suite 120 Puyallup, WA 98374-2115, USA Telephone: 1-800-562-4789 E-mail: Help@wirb.com.

7 7 Luxembourg or the Greater Region?

8 How can we better manage the symptoms of Parkinson disease (PD) together? People with PD have different symptoms. These symptoms can change day-to-day and over time. The purpose of this study is to help us understand the different symptoms of PD. The results of this study may help researchers develop new ways to manage PD symptoms. This study uses an app to monitor PD symptoms. Sage Bionetworks (nonprofit) has developed this app to make it easier for people to participate in this research. If you participate in this study, you will be asked to complete surveys and activities. The activities use your phone’s built-in sensors to collect information about your health and the symptoms of PD -- like balance and dexterity. If you are over 18 years old, you can join the study. We are looking for volunteers with PD and volunteers who do not have PD (“controls”) to join this research study. Both groups are important to the study. 8 This overview explains the research study. After you learn about the study, you can choose if you would like to participate. This may take about 20 minutes to complete. Learn more about the study first

9 9 It is important to know what this study is about and what is involved. Before you can join, we will ask you to take a short quiz to test your understanding. Because this is a research study, we want volunteers to understand the purpose of the study. Also, volunteers need to understand what they will be asked to do. We will tell more about these topics in this overview. If you have questions, please contact us. You should not volunteer until all of your questions are answered. At the end of this overview there is a short quiz. You can go back to the screens describing the study as many times as you need to pass the quiz. Contact information is a popup hyperlink: Please contact the study team in Luxembourg by phone at +352 44 11 4848 or email at parkinson@chl.lu, or contact the study sponsor in the US at +1-206-667-2129 (toll free at +1-844-822-4708) or email PDAppLu@sagebase.org+352 44 11 4848 parkinson@chl.luPDAppLu@sagebase.org

10 10 Activities & Surveys We will ask you questions about your health and your medical history. We will ask if you have PD and if you take certain medications. Because the purpose of this study is to look for patterns over time, we will ask you to review and update your answers from time to time. We might also ask new questions about your mood or how well you slept. These questions are important for the research study We will ask you to do simple activities. For example: Say “aaah” into your phone’s microphone for 10 seconds. This is to measure variation in your voice. Walk and/or stand still with your phone in your pocket. This is to measure your gait and balance. Tap your fingers on your phone’s screen. This is to measure your speed and coordination. Play a short game. In this game, flowers light up in pattern. We ask you to tap the flowers in the same pattern. This is to test your short-term memory. Hold your phone for 10-15 seconds. This is to measure tremor in your hand. These activities need your phone’s sensors on, including the GPS to calculate how far you travel. We do not use the GPS to find out your location. You can enable notifications from the app to receive reminders to do these surveys and activities. To understand changes in your health, we will ask you to complete surveys and simple activities daily and weekly. We will look for patterns over time.

11 11 Your phone contains many sensors. For example, it has a gyroscope and an accelerometer. These sensors are also found in fitness trackers like the Apple Watch, Fitbit, and Jawbone Up. These sensors measure your physical activity. With your permission we’d like to add sensor data from your fitness tracker to the study. This is an optional part of the study. You can still participate in the study if you do not allow us to gather data from these sensors. We will NOT access other apps on your phone. Also, we will NOT access your contacts, photos, texts, or email. The sensors on your phone will collect data when you use the app. Some people wear fitness trackers. We will ask your permission to add the data from the sensors on your fitness tracker to the study. You do not have to agree. Learn more

12 12 Your phone contains many sensors. For example, it has a gyroscope and an accelerometer. These sensors are also found in fitness trackers like the Apple Watch, Fitbit, and Jawbone Up. These sensors measure your physical activity. With your permission we’d like to add sensor data from your fitness tracker to the study. This is an optional part of the study. You can still participate in the study if you do not allow us to gather data from these sensors. We will NOT access other apps on your phone. Also, we will NOT access your contacts, photos, texts, or email.

13 13 View your data trends You can view your data at any time. When you look at your data you may notice patterns. Seeing health patterns can generate a wide range of emotions. This is your data. You’ll be able to view your recent data trends on the app dashboard and download your measurements. Seeing your data may change how you feel. You may feel tired, sad, energized, or happy.

14 14 Your privacy We will protect your privacy to the best of our ability. Your data will be encrypted on your phone. We will replace your name with a random code and store your coded study data on a secure cloud server. But we cannot promise total privacy. Your privacy is important to us. We will make every effort to protect your privacy. The data we collect through the app is encrypted on the phone. This means your data is protected. Unauthorized people cannot easily understand your data when it is encrypted. We will separate the account information that identifies you from your study data. Your account information will not be stored with your survey responses or app measurements. Instead of using your name, we will use a code to label your study data. The code is random. It is not based on any of information that identifies you. Information about the code is stored in a separate database on a secure server. Only key people from our study team can link your identity to your study data. Results of this study will be made public. When results are made public, only coded study data will be used. Your identity will not be shared. If required by law, we may give your contact information and identifiable study data to: · The US Department of Health and Human Services (HHS), the Office for Human Research Protection (OHRP), the Food and Drug Administration (FDA), and other agencies for review of our research procedures · The Institutional Review Board (IRB) and Comité National d’Ethique de Recherche ( CNER) so they can monitor the safety, effectiveness, and conduct of our research Please read our Privacy Policy for more information. WE WILL NEVER SELL, RENT, OR LEASE YOUR CONTACT INFORMATION.

15 15 ItIt Data Use Your coded study data will be used for research. It will be combined with data from other volunteers. It will be transferred to an analysis platform in the United States. We will process your data electronically. We will combine your coded study data with the coded study data of other volunteers. We will store this combined coded study data in the United States on the Synapse data analysis platform. Synapse is run by Sage Bionetworks (non-profit). We will analyze the combined coded study data. We will look for patterns. These patterns may help us better understand the symptoms of PD. Also, we will investigate how mobile phones and sensors perform in this type of research. Our goal is to improve the quality of life for people with PD. We will not use the coded study data for commercial advertising.

16 16 Research takes time. Before you volunteer, it is important to know how much time is involved. Signing up to volunteer takes about 20 minutes. After that, the study takes about 20 minutes per day. Once a month, we ask follow up questions. These take about 5 minutes to complete. You decide when and how much to participate. You can stop and start your participation at any time. Transmitting data collected in this study may count against your mobile data plan. You may configure the application to only use Wi-Fi connections to limit the impact this data collection has on your data plan. Time commitment This study will take about 20 minutes per day. Monthly reviews may take an additional 5 minutes once a month. The time you spend on the app may count against your mobile data plan. You can set up the app to use Wi-Fi connections instead. Learn more

17 17 We will ask you to answer different health surveys. Some of these surveys have been used in other PD research studies. Some of the surveys are new. Some of the questions in the surveys may be mildly stressful for some people. Because we are looking for health patterns over time, we will ask you some of the same questions more than one time. This may seem silly, but it is important to our research. So that we have the best chance at making useful discoveries, some questions are mandatory. For example, you have to tell us if you have PD or not. We also must know if you take certain medications. Other questions are optional. You can skip any optional question you do not wish to answer. Surveys are an important part of this research study. We will ask you to complete weekly and monthly surveys about your health. s

18 simple 18 The primary benefit of this study is increasing understanding of the symptoms of PD. We will be looking for health patterns across large groups, not individual health trends. You may or may not benefit from volunteering for this research study. You will be able to view and download your study data. You can share your data with anyone you choose. The mPower app is not a personal diagnosis tool. Potential benefits Your participation in this study could help researchers understand PD better. You may or may not benefit from this research study.

19 19 This is not a medical treatment study. We do not expect medical side effects from participating in this study. We take great care to protect your privacy. However, if there is a data breach it may be possible to identify you. This risk is low but it is not zero. Participating in this study may generate a wide range of emotions. It could affect your mood. Be aware that other people may glimpse the study notifications and/or reminders on your phone and realize you are enrolled in this study. Participation in this study may involve risks that are not known at this time. You will be told of any new information that might change your decision to be in this study. Potential Risks If you participate in this study, your privacy may be at risk. There may be other risks to participating that we do not know about yet. Learn more

20 20 mPower is a research study. The mPower app is not a diagnostic tool. It shouldn’t be used for medical care, diagnosis, or treatment. You should not use mPower in place of seeing a healthcare provider. The sensor data collected through the app are not yet validated as measurements of PD symptoms. We are analyzing this data to see how accurate and reliable it is. If you have questions or concerns related to your health, you should see a healthcare provider. NOT medical care mPower is not used for medical care. It is a research study. The mPower app is not a diagnosis tool. We do not give medical advice or treatment recommendations.

21 21 We might want to reach out to you. You can opt out of these follow up notifications at any time. We may reach out to you. We might want to alert you to research events, like webinars. We might want to tell you about other research opportunities. You can still participate in mPower even if you opt out of these follow up notifications. There are two ways to opt out of follow up notifications. You can adjust the “permissions” setting in your mPower profile. Or you can contact us. Contact information is a popup hyperlink: Please contact the study team in Luxembourg by phone at +352 44 11 4848 or email at parkinson@chl.lu, or contact the study sponsor in the US at +1-206-667-2129 (toll free at +1-844-822-4708) or email PDAppLu@sagebase.org+352 44 11 4848 parkinson@chl.luPDAppLu@sagebase.org

22 22 You may pause your participation or leave the study at any time. If you pause your participation, you can continue using the app. Your data will remain on your phone. It will not be included in the study. You can resume your participation at any time. If you leave the study, you withdraw your consent. You will be logged out of your account and no more data will be collected. If you wish to re-enroll at a later date you will be asked for your informed consent again. Your coded study data from before your pause or withdrawal will continue to be used in the study. It will not be destroyed or deleted. The study team may also withdraw you from the study at any time for any reason. There are two ways to pause or leave the study. You can do so directly from your app profile page. Or you can contact us. You can also uninstall the app from your phone at any time. Contact information is a popup hyperlink: Please contact the study team in Luxembourg by phone at +352 44 11 4848 or email at parkinson@chl.lu, or contact the study sponsor in the US at +1-206-667-2129 (toll free at +1-844-822-4708) or email PDAppLu@sagebase.org+352 44 11 4848 parkinson@chl.luPDAppLu@sagebase.org Pause or Quit Your participation is voluntary. You can pause your participation or you can leave the study at any time.

23 23 Your participation is voluntary. Take time to think it over. If you have any questions about this study, please contact us. If you would like to speak to someone other than us about this study, please contact the Western Institutional Review Board (WIRB) in the US. WIRB is a group of experts who independently review research. WIRB will address any concerns or complaints you have about this study. They will also help with any questions or concerns about your rights as a research participant. Think it over Your participation is voluntary. Take time to think it over and ask questions. Contact information is a popup hyperlink: Please contact the study team in Luxembourg by phone at +352 44 11 4848 or email at parkinson@chl.lu, or contact the study sponsor in the US at +1-206-667-2129 (toll free at +1-844-822-4708) or email PDAppLu@sagebase.org+352 44 11 4848parkinson@chl.lu PDAppLu@sagebase.org Contact information is a popup hyperlink: Western Institutional Review Board ® (WIRB ® ) 1019 39th Avenue SE Suite 120 Puyallup, WA 98374-2115, USA Telephone: 1-800-562-4789 or 360-252-2500 E-mail: Help@wirb.com.

24 24 Future independent research Learn more: The same coded study data that you donate for mPower could be used for other research. We give you the option to share your coded study data with other researchers worldwide for other research. You get to decide if you want to share your coded study data for other research. Here are important points to consider when deciding: First, research using the shared coded study data can be on any topic, not just PD. The research might be on topics you disagree with or find offensive. Second, you cannot take back your data once it is used in another research study. Third, future research may lead to patentable discoveries or commercial product(s). You will not profit from these future research. For example, you will not be paid for being in the study and/or sharing your data. Think carefully about sharing your coded study data for other research. Make the choice that feels right for you.

25 simple 25 You can only share your coded study data. This is to protect your privacy. Your coded study data does not include your name or information that directly identifies you. Instead of using your name, we use a random code to label your study data. This is your coded study data. Researchers will not be able to easily figure out your identity using your coded study data. Sharable data are coded study data from: Survey responses Activity measurements Comments you make through the app Fitness tracker sensor data (if applicable) Recordings or Photos taken within the app (if applicable) Sharable Data Only coded study data are sharable. Coded study data do not include your name or email address. A random code is used instead. Learn more

26 26 Learn more: We share coded study data with qualified researchers worldwide. Who are qualified researchers? Qualified researchers must register on Synapse, our data- sharing and analysis platform. To register, researchers must tell us their name, email address, company, and location. This information is public. Also, qualified researchers must write a short statement about their research. We post these statements publically. You can review them at https://www.synapse.org/#!Synapse:syn4993293/wiki/392026. Finally, researchers must sign an oath. They agree to use the data ethically and to do no harm. They promise to not identify you or contact you without your permission. You can review the oath on synapse. Anyone in the US or abroad can apply to become a qualified researcher. For example, doctors working at hospitals or scientists at universities. Researchers who work for commercial companies, like drug manufacturers, can apply. Private citizens can also apply. If we change these rules for any reasons we will let you know. Qualified Researchers With your permission, we will share your coded study data with qualified researchers worldwide. We have rules to qualify researchers. However, we do not control the research that they do with the shared data.

27 27

28 28 Give medical advice and diagnose people with Parkinson disease. You are correct. The purpose of this study is to better understand the fluctuations of Parkinson’s disease symptoms. It is not a treatment study. The app does not replace your usual medical Care. Give medical advice and diagnose people with Parkinson disease. The correct answer is to understand the fluctuations of Parkinson’s disease symptoms. This is not a treatment study. The app does not replace your usual medical care.

29 29 You are correct. Your name and contact information will not be stored with your study data. We will use a random code instead of you name on all your study data. The correct answer is No. Your name and contact information will not be stored with your study data. We will use a random code instead of you name on all your study data.

30 30 I decide to share my data with qualified researchers. Then I change my mind. Can my data be deleted from their studies? The correct answer is No. Your coded study data cannot be deleted once it is used in another research. You are correct. Your coded study data cannot be deleted once it is used in another research.

31 31 Some survey questions may be slightly stressful You are correct. Answering questions may elicit a wide range of emotions. It can be stressful The correct answer is Yes. Answering questions may elicit a wide range of emotions. IT can be stressful.

32 32 I can pause/resume participating at any time You are correct. Your participation is voluntary. You may withdraw your consent and discontinue participation at any time. To withdraw, contact the researcher, delete the app or choose the withdraw link on your profile page. The correct answer is Yes. Your participation is voluntary. You may withdraw your consent and discontinue participation at any time. To withdraw, contact the researcher, delete the app or choose the withdraw link on your profile page.

33 You answered one or more questions wrong. We want to make sure you understand what this study is about and what is involved. Review the information screens and try again. If you have questions, please contact contact the study team in Luxembourg by phone at +352 44 11 4848 or email at parkinson@chl.lu, or contact the study sponsor in the US at +1-206-667-2129 (toll free at +1-844-822-4708) or email PDAppLu@sagebase.org+352 44 11 4848 parkinson@chl.lu PDAppLu@sagebase.org or 33

34 Learn more: You get to decide if you want to share your coded study data for other research. You have two options: Yes. Choose “yes” if you would like to share your coded study data for other research. If you choose “yes” your coded study data will be used for mPower research. It will also be used for other research by qualified researchers. No. Choose “no” if you want your coded study data only used by us for mPower research. Your data will not be used for other research. You can change your mind at any time. Go to the Data Sharing setting in the app to update your choice. Note that, we may be required by law to share both your contact information and identifiable study data with: · The US Department of Health and Human Services (HHS), the Office for Human Research Protection (OHRP), the Food and Drug Administration (FDA), and other agencies for review of our research procedures. · The Institutional Review Board (IRB) and Comité National d’Ethique de Recherche (CNER) so they can monitor the safety, effectiveness, and conduct of our research. The study team (Parkinson Research Clinic (Luxembourg), Sage Bionetworks and their partners) will receive your study data from your participation in this study. YES- Share my data with the study team and qualified researchers worldwide NO- Only share my data with the study team 34

35 By agreeing you confirm that you read the information and that you wish to take part in this research study 35

36 36 Enter your Participant study IDEight-digit alphanumeric code Repeat input of Participant ID as a Registration step. The alphanumeric code will be taken from a list of 3000 pre-generated codes already shared between Venkata and Alx. Please sign the printed mPower consent document. This document will be added to your clinical records held at the Parkinson’s Research Clinic.

37 37 the symptoms of PD Register

38 38 Repeat input of Participant ID as a Registration step

39 39

40 40

41 41 Verification of email address and receipt of signed consent form

42 42 Set up Permissions and profile

43 43

44 44

45 We want to understand how certain medications affect the app activities. To do that we need more information from all study participants. Please tell us if you have PD and if you take medications from the proposed list. We’ll ask you again from time to time to track any changes. This survey should take about 5 minutes. Diagnosis and Medication Diagnosis and Medication Survey

46 “Next” button is greyed out until an answer is selected. Diagnosis and Medication Have you been diagnosed with Parkinson Disease by a medical professional?

47 Do you take any of these medications ? (Please select all that apply) Diagnosis and Medication Do you take any of these medications (Please select all that apply) Diagnosis and Medication Add option for “unspecified PD medication” that can still trigger the “moment in Day question

48 “Next” button is greyed out until answers are selected. How many times a day do you take these medications? Diagnosis and Medication How many times a day do you take these medications? Diagnosis and Medication

49

50 If the user has previously recorded responses to the medication survey, then they will be directed to the “Moment in Day” question directly. In this case, the step includes explanatory language. The “Next” button is greyed out until the question is answered and the question is not optional. Activity flow with previously selected medication We want to find out if taking medicine influences the results of this activity.

51 51 In this activity we ask you to tap your fingers. It is an activity that tells us about your fine motor coordination. Your doctor may measure your fine motor coordination in a different way. Put your phone on a flat surface. Use two fingers on your right hand to tap the buttons on the screen. Tap one finger, then the other. Try to time your taps to be as even as possible. Keep tapping for 20 seconds. Tap the next button to begin. Put your phone on a flat surface. Use two fingers on your left hand to tap the buttons on the screen. Tap one finger, then the other. Try to time your taps to be as even as possible. Keep tapping for 20 seconds. Tap the next button to begin. Bi-lateral Tapping

52 52 This step assesses background noise. Phonation In this activity we ask you to say, “Aaaah.” It is an activity that tells us about your vocal tremor. Your doctor may measure vocal tremor in a different way. This activity uses your phone’s microphone. Hold your phone so you can easily see the screen. Take a deep breath and say, “Aaaah,” for as long as you can. Try to keep the volume of your voice steady so the audio bars remain blue. Tap the next button to begin. Next

53 53 Find a place where you can walk safely back and forth in a straight line. Press the get started button. Then put your phone in your pocket or in a bag. Follow the audio instructions. In this activity we ask you to walk and stand still. Do not do this activity if you cannot walk safely unassisted. It is an activity that tells us about your gait (walk) and balance. Your doctor may measure your gait and balance in a different way. Walk back and forth in a straight line for 30 seconds Walk as you would normally. Gait and Balance

54 54 Memory The flowers will light up one at a time. Watch carefully. Then tap the flowers in the same order they lit up. Tap the next button to begin. In this activity we ask you to remember a pattern. It is an activity that tells us about your short-term memory Your doctor may measure short- term memory in a different way. Memory

55 55 Tremor – 5 assessments Resting Tremor Intentional Tremor

56 56 Postural Tremor Kinetic Tremor Pronation/ Supination Not yet implemented

57 Surveys Background: Demographic, health history PD history Validated health surveys: MDS-UPDRS PDQ8 …

58 Purpose Tell us how you feel. We’ll ask you to rate your mental clarity, mood and pain level today as well as how well you slept and how much exercise your have done in the last day. You will also have an opportunity to track any activity or thought that you choose yourself. Length This activity should take less than two minutes to complete Get started

59 How would you rate your pain today?

60 60

61 61 How long will this take? Instructions Instructions: Make sure your phone is charged daily. First, answer the survey questions to tell us more about your health. Then complete the activity sessions and check-in daily. Each activity session contains the following activities: 1.Tapping on the phone screen repeatedly to test your motor speed and coordination. You will be asked to tap with your right and left hand. 2. Saying “aaah” in the phone for as long as you can to record variations in your voice. 3. Memory game where you are asked to recall highlighted objects. 4. Walking forward or standing still with your phone in your pocket to assess your gait and balance. 5. Holding your phone in several positions to measure tremor in your hands 6. Rating your thinking, mood, pain level, sleep quality and level of exercise Prior to initiating a session make sure you are wearing pants with a pocket. How do I quit the study?

62 62 How long will it take? It takes approximately 15 minutes to complete each activity session. What to do if I missed a session: There isn’t a scheduled time to complete the activity session. Contact us: Please contact the study Coordinator in Luxembourg and the Greater Region with any questions or concerns by phone at +352 44 11 4848 or email at parkinson@chl.lu. Call the the study sponsor in the US by phone at+1-206-667-2129 (toll free at +1-844-822-4708) or email at PDAppLu@sagebase.org.+352 44 11 4848parkinson@chl.lu+1-206-667-2129PDAppLu@sagebase.org In the event the phone is lost, please contact the study coordinator as soon as possible. How do I quit the study? Your participation is voluntary. To quit the study, please uninstall the app from your phone. The data already collected will continue to be used in the study. It will not be destroyed or deleted.

63 Participants can view their own data on the dashboard 63

64 64 Profile page- scroll down  Profile page needs editing since we do not collect participant’s name or birthdate

65 65 Selecting “Leave Study 

66 66


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