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EpiWatch: Frequently Asked Questions

Help Advance Epilepsy Research As You Track Your Seizures and Medications

 

EpiWatch: Frequently Asked Questions

1. What should I know about this study?

The EpiWatch™ Research Study is an Apple Watch™  app that uses surveys and other interactions to track your seizures and to collect data for the study.

Your use of the EpiWatch app means you are participating in the study. Your participation is entirely voluntary. If you choose to use the app and participate in this study, you can change your mind later and discontinue your use of the app and participation in the study.

An electronic study information guide in the app also explains what to expect as a participant in the EpiWatch Research Study.

2. What will happen if I choose to participate?

Activities

While participating in this study, you will be asked to perform tasks and respond to brief surveys whenever you have a seizure. You may also be asked to take surveys at other times as well. Your responses will be collected for analysis as part of this research.

You will be able to review all the information you manually enter into the app about your seizures and their treatment. This information will be displayed in a dashboard on the app. You may find it useful to share this information with your physician.

We will use this information to help analyze the sensor data collected from Apple Watch during your seizures, and to learn more about seizures and their treatment among participants in this study. Although some of the sensor data may be reported in other apps, you will not have access to all the sensor data collected during your seizures by the study.

Periodic Study Surveys

We will ask you to answer an initial health survey plus brief daily surveys. Every month we will also invite you to update information about the seizures you tracked, as well as their treatment in order to track any changes that may be relevant to this study.

  • Initial health survey (< 10 min)
  • Post-seizure survey (< 2 min, anytime you experience a seizure)
  • Daily survey (< 1 min)
  • Other surveys (optional).

We will ask you to answer questions about your seizures and any other medical conditions or health information that may impact their occurrence or treatment.

We will send notifications through your devices asking you to complete surveys for this study. You may choose to complete the surveys at your convenience.

About the Surveys

The initial health survey will collect valuable information about your seizures and their treatment, which will be used for the study, and also to customize the app for your use in tracking seizures. We will also ask you questions about yourself that are often relevant for patients with seizures. Seizures, for example, can influence employment and lifestyle, and we ask brief questions about these.

The brief post-seizure survey will ask you a few questions about the type and severity of the seizure you had, after you have recovered from it. We plan to use this information, along with your movement and heart rate data and your responses to the app during the seizure, to develop a seizure detector for use in a future app. We will also ask you if you have any possible trigger factors that might have contributed to your having the seizure.

You will complete the brief daily survey regarding seizure activity and medication adherence in the last 24 hours. You will receive a reminder to do this activity every day at the time of your choosing. You will also be able to enter additional information if you wish to update your seizure and medication logs.

Every month we will invite you to review and update the information you have logged in the app. You may also do this at any time to keep track of changes in your seizure type and frequency, medications, and medication side effects. We will also periodically invite you to complete other surveys over time, for example on your quality of life.

Study Activities and Tasks

We will ask you to perform specific activities and tasks during this study, such as opening the study app on Apple Watch and responding to prompts when you are experiencing a seizure, or if you feel a seizure about to start.

Activities and tasks include:

  • Baseline data collection from Apple Watch
  • Seizure tracking tasks (opening the app on Apple Watch, responding to prompts, completing surveys)

About the Tasks

When you first start using the app, you will collect baseline data from Apple Watch to compare with the data you collect during seizures. This data will include heart rate data during rest (5 minutes) and during exercise (4 minutes). We will also ask you to play a brief memory game that will be used to test your responsiveness during seizures.

Whenever you feel a seizure is beginning or is about to start, you will perform a set of seizure tracking tasks with Apple Watch:

  • You will open the EpiWatch app on Apple Watch to start recordings of your movements and heart rate for the next 10 minutes. If you are unable to do this, a family member or other caregiver may do this part of the task for you.
  • You will respond to prompts on Apple Watch to confirm that you want to log a seizure and to send a notification about it.
  • You will tap on the Watch and play a brief memory game to test your responsiveness. If you cannot tap or complete the game, this will be repeated until you can.
  • Once sensor data collection is complete (10 minutes) and you have successfully completed responsiveness testing, or if you could not complete responsiveness testing within 30 minutes, we will ask you to complete the brief post-seizure survey (see above).

The duration of these seizure tracking tasks will depend on the duration of your seizure and how long it takes for you to recover.

You may not be able to respond to any of the prompts for responsiveness testing or the post-seizure survey. If this happens or you are unable to open the app at the start of your seizure, you may log the seizure after it is over in your seizure diary.

Sensor Data

With your permission, this study will gather sensor data from Apple Watch as well as your behavioral responses to prompts whenever you report the onset of a seizure.

You will have the option to contribute activity data and your behavioral responses to this app during your seizures. The activity data will be collected through:

  • The sensors on Apple Watch and other devices
  • Other applications and data available through the Apple HealthKit app

You can choose to contribute just some or none of these data, and still participate in the study.

NOTE: We will NOT access your personal contacts, other applications, personal photos or videos, nor text or email messages.

Data Processing

Your study data (survey, sensor data, and behavioral responses) will be de-identified and combined with similar data from other participants.

We will separate your account information (name, email, contact information, etc.) from your study data, which includes sensor data and behavioral responses during seizures you report and your responses to surveys. This will de-identify your study data.

We will combine your de-identified study data (without your name) with those of other study participants to be analyzed.

WE WILL NEVER SELL, RENT, OR LEASE YOUR CONTACT INFORMATION.

3. How are the data protected?

We will replace your name with a random code. The coded data will be encrypted and stored on a secure cloud server under the control of Johns Hopkins University and its research technology partner to prevent improper access.

We will use a random code instead of your name on all your study data. This code cannot be used to re-identify you.

4. How will the study use my data?

Your encrypted data will be used for research and may be shared with other researchers worldwide.

By analyzing the data from all app users, we may be able to better achieve the goals of this study. We may also make more progress by sharing this data with other researchers.

Transmitting the data collected in this study may count against your existing mobile data plan if you are not on WiFi. However, the amount of data generated and transmitted by the app is expected to be small.

5. How much time will it take to participate?

We hope you will commit to the study for 6-12 months. Your commitment to share data over this extended period of time is valuable to researchers seeking to help epilepsy patients.

The initial survey and monthly follow up survey should take no more than five minutes each. The daily seizure and medication survey should take less than a minute each day. The time it takes to record a seizure on the app will vary by person; it will depend on how long your seizures last and how frequently your seizures occur.

We will notify you to complete a brief daily survey as well as a monthly survey. You may choose to complete these at your convenience.

6. Can I choose not to participate?

Your participation in this study is voluntary. You may withdraw your agreement to participate in the study at any time.

You may choose to leave the study at any time. If you choose to withdraw from the study, we will stop collecting new data. The coded study data that you have already provided, and that has already been distributed, will not be destroyed or deleted.

To withdraw from this study, please tap on the “Leave Study” link in the profile page of the application, or contact Dr. Gregory Krauss.

7. What are the potential benefits of participation?

We cannot guarantee any direct benefits to you, but you may find learning more about trends in your seizures and how they relate to your treatment as a potential benefit.

The scientific benefits of this study are primarily to gather data for the development of a future app that can detect and classify seizures so that caregivers can be notified when help may be needed. However, this app will not detect seizures.

Other benefits of this study will be to learn more about what factors predict the occurrence, frequency, and severity of seizures. The researchers may also learn more about the impact of education and the usefulness of a seizure tracking app for the management of seizures.

We will return any insights learned from this study through public communications or research publications, but these insights may not be of direct benefit to you.

We cannot, and do not, guarantee or promise that you will personally receive any direct benefits from your participation in this study. However, you will be able to track your health and share this information with your medical doctor and anyone you choose.

8. What are the risks of participation?

This is not a treatment study, and we do not expect any medical changes from participating. However, participating in this study could cause unexpected emotions, stress, fatigue, or concerns.

Use of the app could be distracting. Please wait until you are in a safe place to perform study-related activities.

Use of this app could allow others around you to know you are possibly having a seizure; this could lead to loss of privacy about having epilepsy.

Other people may notice the study notifications and/or reminders on your phone and realize you are enrolled in this study. This could compromise your privacy and make you feel self-conscious.

There is a risk that you will find responding to the app’s signals distracting or stressful. You may get tired or find it stressful to submit health information requested by the app, such as recording your seizures and your medication dosage.

You will be asked to use Apple Watch to measure your heart rate at rest and during brief, gentle exercise. You may find this tiring. You may omit this testing if you find it too strenuous or have medical or other restrictions.

Some questions may make you feel uncomfortable. If so, you may choose not to answer them.

Participating in this study may change how you feel about your seizures and their treatment. You may feel sad, angry, or anxious about your seizures as a result of participating.

Participation in this study may involve risks that are not known at this time. You will be told about any new information that might change your decision to participate in this study.

9. Is there a risk to my privacy?

We will make every effort to protect your information, but total anonymity cannot be guaranteed. Please read this Privacy Statement carefully.

We take great care to protect your information; however, there is a slight risk of loss of privacy. This is a low risk because we separate your personal information (information that can directly identify you, such as your name or phone number) from the research data to respect your privacy. However, even with removal of this information, experts in re-identification may be able to reverse our processes and/or attempt to re-identify an individual given enough cross-reference information about him or her.

Accidental public disclosure may occur due to unintended data breaches including hacking or other activities outside of the procedures authorized by the study.

10. Will you share my information?

The EpiWatch study will receive your data from your participation in this study. Sharing your de-identified data more broadly (without information such as your name) may benefit this and future research.

To make more progress in our research, we may share your de-identified data, which includes sensor data and behavioral responses reported during seizures, along with survey responses, with other researchers worldwide.

11. Who is running this study?

The EpiWatch study is directed by researchers at the Johns Hopkins University School of Medicine.

For questions, comments, or requests regarding the privacy policy or our processing of your information, please contact EpiWatch@jhmi.edu.

12. Do I get any money for participating?

You will not be paid for being in this study.

13. Does it cost anything to participate?

The EpiWatch study app is free to download on Apple Watch. Johns Hopkins does not charge you any fees to participate in the study. Participating in the EpiWatch study may incur costs from your mobile data plan if applicable.