MIPACT

FAQ

MIPACT Study FAQ

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Contact us at 833-249-9563 or MIPACTstudy@med.umich.edu with questions about participating in the study.

What is the Michigan Predictive Activity and Clinical Trajectories (MIPACT) Study?
The MIPACT Study is a University of Michigan research study that aims to understand the relationship between biosensors, health information, and health outcomes. Researchers will collect several types of data from participants including:

  • Electronic health records
  • Participant survey data
  • Genetic information
  • Blood pressure measurements
  • Apple Watch activity and clinical data

This study will not provide any treatment. It will collect information for research purposes. The University of Michigan and Apple are collaborating to complete this study. The study is sponsored, in part, by Apple Inc.

Participants in the study will help us understand the role of wearable mobile devices in predicting the onset of common health conditions and understanding the health trajectories of participants with these conditions. With appropriate permissions (such as legal, regulatory, and ethical board), your information may also be shared with other researchers at University of Michigan, around the world, and with other companies.


Why should I participate?
As a participant in this study, you will help us generate knowledge on how Apple Watch technology, genetics, survey data, and electronic health information can help us understand health, wellness, and the trajectories of chronic diseases. You will play an integral role in helping researchers understand health outcomes for potentially millions of Americans.

Who can participate?
Interested parties must meet all of the following criteria to be eligible to participate in the study:

  • Must be 18 years or older and resides in the United States
  • Must be a patient within the Michigan Medicine clinical system
  • Must have an iPhone 6 or later with latest version of iOS
  • Must understand English
  • Must have internet access throughout the study period
  • Must be able to use a consumer-friendly home blood pressure cuff
  • Additional demographic and clinical requirements

The study team will screen for additional criteria during the enrollment process.

How long will the study last?
The study will last three years. The first phase of the study lasts up to 45 days, and is followed by a second phase of up to three years of continued participation.

What will I need to do if I join the study?
During enrollment, you will be asked to download three apps to your iPhone, and donate a blood sample (about 2 tablespoons). You will be asked to take your blood pressure twice a day for at least 15 days and wear an Apple Watch regularly. The Apple Watch and wireless blood pressure cuff will be provided to you for the purposes of the study.

During the second phase of the study (see How long will the study last?) you will be asked to complete the same tasks, but on a monthly, as opposed to daily, basis. Both phases of the study will include health questionnaires and surveys.

How do I join the study?
In order to join the study, interested persons who meet the initial eligibility criteria (see Who can participate?) should call the study team at (833) 249-9563 Monday-Friday, 8am-5pm, to schedule an appointment for consent and enrollment. We expect an appointment to last between one hour (60 minutes) and one and a half hours (90 minutes).

Do I need to own an Apple Watch to participate in the study?
No, you will be provided with an Apple Watch and wireless home blood pressure cuff for the purpose of completing study tasks.

Is this going to cost me anything?
No, the study will not cost you anything directly. There may be indirect costs to participation because some of the data collected for this study and transmitted to the study team and Apple will need to be covered by your iPhone’s data plan.

What data will be obtained?
Information that will be obtained includes:

  1. A blood sample, lab test results, and certain genetic data
  2. Personal health information, such as demographic information, medical records, and health history
  3. Device and application data, such as number of steps taken, distance walked, heart rate, blood pressure, survey data, and other biosensor (accelerometer, gyroscope, photoplethysmography) data.

What happens to my data?
Your contact information and other device-related information that directly identifies you will be separated from your other study data and replaced with a random code (coded study data) before it is used for research purposes. As part of the study, Apple will only access coded study data and will not have access to your contact information, device identifiers, biospecimens, and certain electronic health record data (doctor’s notes, images, videos, pharmacy information). Your coded study data will not be linked to other data that Apple may have from your use of other Apple devices and services.

Who will have access to my data?
With appropriate permissions, your data could be shared with approved researchers inside and outside the University of Michigan, including those in other countries and those working with companies, and with Apple.

How will my privacy be protected?
Whenever possible, donated samples and your health information will be stored with a code instead of identifiers (such as name, date of birth, medical record number). However, the more information about you that is combined, however, together, the more likely it is you could be identified.

All information used by this project will be protected so that it can only be accessed by authorized people. The study team will do its best to ensure that the study data is kept private and secure. Your study data will be stored and transmitted using secure systems. However, total confidentiality cannot be 100% guaranteed.

There is always a risk that you could be identified by your blood sample and health information. It is possible that there could be unauthorized access to or a breach of the systems where your data is stored.

No published scientific reports or presentations will identify you directly.

Do I get compensated for my time in the study?
You may be eligible for compensation depending on your level of compliance with the required study tasks.

What is the commercial gain associated with this study?
This study has both research and product development purposes. The sponsor has no plans to offer you financial compensation or share any profits from the commercialization of any products, processes, or services developed from your study data. You will not, however, lose any legal rights to which you are entitled by agreeing to participate in this study.

Whom can I contact if I have questions about the study?
The MIPACT study team can be reached at (833) 249-9563 or mipactstudy@med.umich.edu during business hours (M-F, 8am-5pm).

How do I withdraw from the study?
You can withdraw your participation at any time. To stop participating in the study, please call (833) 249-9563 during business hours (M-F, 8am-5pm).

What happens if I change my mind about being in this study?
After you decide to participate, you can withdraw your participation at any time. To stop participating in the study, please call (833) 249-9563. After you withdraw, no further data will be collected about you for study purposes. Please keep in mind that data collected prior to your withdrawal may continue to be used for research purposes.

The study team or sponsor can stop your participation at any time without your consent for the following reasons:

  • If you fail to follow directions for participating in the study
  • If it is discovered that you do not meet the study requirements (for example, owning an iPhone 6 or later; currently living in the US; willingness to keep contact information updated and be contacted) or if there is a clinical reason for you to stop participation);
  • If the study is terminated

What is an Institutional Review Board?
An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, and/or concerns or complaints regarding this research study, you should contact the Institutional Review Board at:

IRBMED
2800 Plymouth Rd, Bldg. 520, Room 3214
Ann Arbor, MI 48109-2800

irbmed@umich.edu

734-763-4768

Reference this study (MIPACT), with HUM#00148297 in your communication. The IRB will not be able to answer any study- or app-related questions; for all questions about the research study, including technical support, please call (833) 249-9563.

For more information about the IRB, please visit this link.

Study Team Contact Hours
Monday-Friday, 8am-5pm

Disclaimer: These FAQ are meant to serve as guidelines only and may be updated if needed. Study participants with questions should call (833) 249-9563 or email mipactstudy@med.umich.edu.