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44 | petentium accusamus mea.
45 |
Track changes by answering a weekly and monthly survey
16 |
Perform activities three times a day to measure your voice, walking and tapping
17 |
18 |
19 |
20 |
21 | The
22 | MyHeartCounts
23 | app will ask you to do 3 activities: 1) use your phone, or any wearable activity device you
24 | have, to collect activity data for 7 days; 2) perform a 6-minute walk test of fitness; and 3)
25 | enter information about risk factors and blood tests to calculate your American Heart
26 | Association risk score.
27 |
If you use a personal health device with your iPhone (such as a Apple Watch) and use iOS8 or
16 | later (which includes Apple HealthKit), you can choose to include the data from the device in
17 | the study. You can set our app to get all, some, or none of the data. You can choose not to do
18 | this and still participate in the study.
19 |
20 |
21 | You will have the choice to use the asthma app to receive location-specific information such as
22 | weather and air quality in your area. If you choose to do so, the asthma app will use the
23 | location of your phone to send you information about your general area. The asthma app will
24 | record the location of your iPhone (in latitude/longitude coordinate form) as often as once per
25 | hour when the app is open in order to help identify location-specific triggers, such as point
26 | sources of industrial pollution that may make your asthma worse. You are free to turn off the
27 | asthma app's access to your location. If you do this, your location will not be recorded and you
28 | will not receive location-specific information about air quality.
29 |
30 |
We will NOT access your personal contacts, other applications, phone use habits, text messages,
31 | personal photos, or websites visited.
Your study data without information to identify you may be shared with researchers, but we will
14 | not share your personal information or study information with any commercial third parties such
15 | as advertisers.
We will work hard to protect your privacy. A random code instead of your name or other
15 | information that could identify you will be used on all your study data. Researchers will only
16 | analyze data without information that identifies you.
17 |
18 |
Your study data will be coded and stored in a manner that keeps your information as safe as
19 | possible and prevents unauthorized people from getting to your data. Even with removal of your
20 | personal information and these procedures, it is sometimes possible to re-identify an
21 | individual. This risk, while very low, should still be considered before enrolling.
Before completing the enrollment and creating your study account, we will assess your
15 | understanding and eligibility to provide consent. It is important that you understand what the
16 | study is about and what is involved. You should not join the research study until all of your
17 | questions are answered. Feel free to contact the study sponsor with any questions.
The study team may ask permission to contact you if needed. If you do not want the study team to
15 | contact you, you will have a chance to opt out of being contacted.
Study data will be stored on Amazon Web Services servers under the control of Mount Sinai and
15 | Sage Bionetworks, a non-profit research institution. No one at Amazon Inc. will have access to
16 | the data.
There are sensors in your phone that can help assess activity, plus Apple’s Health app on your
14 | phone can store health and activity data from other devices.
15 |
This study gives you the option to share your data in 2 ways:
15 |
16 |
1- Share with the world: You can choose to share your coded study data with qualified researchers
17 | worldwide for use in this research and beyond. Coded study data is data that does not include
18 | personal information such as your name or email. Qualified researchers are registered users of
19 | Synapse who have agreed to use the data in an ethical manner for research purposes, and have
20 | agreed to not attempt to re-identify you. If you choose to share your coded study data, the
21 | coded data will be added to a shared dataset available to qualified researchers on the Sage
22 | Bionetworks Synapse servers. (www.synapse.org).
23 | Sage Bionetworks will have no oversight on the future research that qualified researchers may
24 | conduct with the coded study data.
25 |
26 |
2- Share with the Institution and its partners only: You can choose to share your study data only
27 | with the study team and its partners. The study team includes the sponsor of the research and
28 | any other researchers or partners named in the consent document. Sharing your data only with the
29 | (Institution) means that your data will not be made available to anyone other than those listed
30 | in the consent document and for the purposes of this study only.
31 |
32 |
If required by law, your data (study data and account information), and the signed consent form
33 | may be disclosed to:
34 |
35 |
The US National Institute of health, Department of Health and Human Services agencies,
36 | Office for Human Research Protection, and other agencies as required,
37 |
38 |
Institutional Review Board who monitors the safety, effectiveness and conduct of the
39 | research being conducted,
40 |
41 |
Others, if the law requires
42 |
43 |
The results of this research study may be presented at meetings or in publications. If the
44 | results of this study are made public, only coded study data will be used, that is, your
45 | personal information will not be disclosed.
46 |
47 |
You can change the data sharing setting though the app preference at anytime. For additional
48 | information review the study website at http://apps.icahn.mssm.edu/asthma/
49 |
The study will take place completely by using this app. While you use the app to monitor your
14 | asthma, we will study how well the app works and use the information to make the app better.
15 |
16 |
The app will ask you questions about your background, your asthma, the asthma medicines you take,
17 | and other questions about your health. Certain questions have to be completed for the app to
18 | work as designed, such as entering your asthma medicines so the app can give you reminders.
19 |
20 |
You will be asked daily questions about your asthma symptoms and use of quick relief medicine.
21 | You can choose the time each day to get your reminder and do your questions. Be mindful of the
22 | alert sound for your notifications if you don’t want anyone to know you are in the study. You
23 | can turn off the sound if you want. Once each week you will be asked about any major things that
24 | happened such as visits to your doctor, the emergency department, the hospital, or changes in
25 | asthma medication.
26 |
27 |
We will not collect information from your medical records. By answering these questions, the app
28 | will keep track of how well your asthma is controlled and you can compare how you are doing to
29 | other app users. There will be questions and surveys at the beginning and end of the study.
30 | Apart from the daily and weekly questions and your medicines, you are free to skip anything that
31 | makes you uncomfortable.
Possible benefits may be that what we learn from the study may help doctors better understand
15 | asthma and design better mobile applications. During the study you will be able to track what is
16 | happening with your asthma and your health overall. You may learn more about asthma and
17 | monitoring your health that may possibly help you and your doctor to keep you healthy. It is
18 | possible that neither you nor others may benefit from taking part in this research.
You should continue your asthma care with your usual doctor if you need help with your asthma
14 | during the study, after the study and also if you choose not to join the study. If you
15 | participate in this research study, you should also tell any health care providers who treat you
16 | that you are in the study.
17 |
18 |
There are risks, discomforts, and inconveniences with any research study.
19 |
20 |
This study does not provide any compensation, health or medical care to participants. If you are
21 | injured as a direct result of your participation in this study, the Principal Investigator and
22 | the research study staff will assist you in obtaining appropriate medical treatment. Email us at
23 | asthmamobilehealth@mssm.edu if you feel you
24 | have been injured as a direct result of your participation in this study. Your medical
25 | insurance, managed care plan, or other benefits program will be billed for this treatment. You
26 | will be responsible for any associated co-payment or deductibles as required by your insurance.
27 |
28 |
29 |
If costs of care related to such an injury are not covered by your medical insurance, managed
30 | care plan or other benefits program, you may be responsible for these costs. The sponsor will
31 | not pay charges that your insurance does not cover. No payment is available from the study
32 | sponsor.
33 |
34 |
Using the app will take some time. Some questions may make you feel uncomfortable. Other people
35 | may see the app or your reminders on your phone and realize you are enrolled in this study and
36 | that you have asthma. This could cause embarrassment or self-consciousness.
37 |
38 |
Be safe. Do not do study tasks while driving. Wait until you are in a safe place to perform
39 | tasks.
40 |
41 |
Data collected in this study will count against your existing mobile data plan, but you can set
42 | up the “asthma app” to only use Wi-Fi connections to limit impact on your data plan.
43 |
44 |
Participation in this study may involve risks that are not known at this time.
45 |
46 |
Giving consent, registering for the study and answering the first set of questions should take 20
15 | minutes. You can stop and restart where you left off at any time. Using the app in this study
16 | will involve daily and weekly tasks that should only take a minute or two each day to complete,
17 | for a total of 15 minutes each week. There will also be special tasks you will be asked to do at
18 | 3 months and 6 months into the study. Your participation in the study will last for 6 months
19 | from the day you sign up.
The purpose of this study is to understand whether using an asthma mobile health
18 | application Version 2.0 (AMHA2.0 or “asthma app”) that you download onto your iPhone
19 | will help you to monitor your asthma.
20 |
21 |
The study is funded by the Icahn School of Medicine at Mount Sinai with technology
22 | support from Apple, Sage Bionetworks, and LifeMap Solutions. We expect that hundreds or
23 | thousands of people may join this study.
24 |
25 |
26 | People with asthma do best if they actively manage their asthma. This app uses your
27 | mobile phone to help you do this. If you take daily asthma medicine, the app will help
28 | you remember to take it on schedule. There are links to learn more about asthma, how to
29 | use your medicine, what triggers your asthma, and how to recognize when your asthma is
30 | out of control. The information you put into the app will help you track how well your
31 | asthma is controlled and how you are doing compared to other app users with asthma.
32 | Although we will look at the data at different points during the study, we will not be
33 | looking at your asthma information each day. The app does not replace your usual medical
34 | care, so if your asthma is getting worse during the study, please reach out to your
35 | health care team.
36 |
37 |
By using this app, you will join a research study, so we will need you to formally give
38 | your consent. We will now tell you what is involved so you can make an informed choice.
39 | Take time to read the full written consent at the end of this signup process before
40 | making your choice. If you have any questions or anything is unclear, stop and email the
41 | study team at asthmamobilehealth@mssm.edu before you sign the consent. If you contact us
42 | by email, you can also ask us to call you with more information or answers to your
43 | questions.
44 |
45 |
You cannot participate in this study if you:
46 |
47 |
48 |
Are younger than 18
49 |
Are pregnant
50 |
51 |
52 |
To join the study, you need to:
53 |
54 |
55 |
Have asthma confirmed by a doctor
56 |
Be prescribed medication for asthma (including inhalers or pills)
57 |
Live in the United States of America
58 |
59 |
60 |
If you are younger than 18 or don’t meet these qualifications, please stop now.
61 |
62 |
If you have any questions or anything is unclear, stop and email the study team at
63 | asthmamobilehealth@mssm.edu before you sign the consent. If you contact us by email, you
64 | can also ask us to call you with more information or answers to your questions.
There will be no penalty to you if you decide not to take part in this study. To stop being in
14 | the study at any time, choose “Leave Study” in the profile section, delete the “asthma app” from
15 | your phone or contact the study team by email. If you withdraw from the study, we will stop
16 | collecting new data, but any data already collected will remain as part of the study. The study
17 | team may also withdraw you from the study at any time for any reason.
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24 | ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in
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25 | ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation
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29 | est laborum
30 |
31 |
32 |
Be 18 years of age or older
33 |
Have doctor-diagnosed robot
34 |
Have been prescribed medication for robot (including robot pills)
As a participant in our Robot research study, you’ll be prompted to complete daily and
23 | weekly tasks that should only take a minute or two a day to complete, for a total of 15
24 | minutes each week. The study lasts for 6 months.
25 |
26 |
The app helps you track your condition, and gives you feedback on your progress.
27 |
