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Recruitment FAQ

1. How should I know whether or not I am eligible for the criteria?


Firstly, you have to be an iphone user because the HeartStep application is
designed only for the ios platform. Secondly, you need to be at the last four
weeks of the cardiac rehabilitation program phase 2 in University of Michigan.
You may confirm this information with your physiologist. If you fulfil the above two
criteria, please contact our researchers by email or through phone to confirm
your eligibility. Also, you can visit the HeartSteps website and do the screening
survey to check your eligibility. If you are eligible, researchers will contact you.

2. How many in-person interviews should I attend?


There are three in-person interview sessions in total. Two intake interview
sessions take place at the beginning of the study and there is one week interval
between the intake interview A and intake interview B. After the 6-month study,
an exit interview will happen to wrap up the study and collect the devices.

3. How should I schedule an intake interview?


Once your eligibility is confirmed, our researchers will reach you through email or
via phone to set up a time for intake interview. An email reminder will be sent out
24 hours before the interview with locations and details of the appointment.

4. How do I know when and where the intake interview takes place?
Our researchers will confirm the time and location of the intake interviews with
you through phone or email. An additional notification containing details of the
location, parking instruction and appointment time will be sent out 24 hours
ahead of the interview via email or text message as a reminder.

5. How long will the intake interview take? What will be discussed?
The two intake interview sessions will take approximately an hour in total. The
session A will take only around 10 minutes. In intake interview A, we will give you
the FitBit Charge 2 device. Notice that the screen of the device are covered and
we will not install the HeartSteps app on your iPhone since we want to collect
baseline data of your step count in daily life before the intervention starts. So
please do not take off the cover on the screen of the device and try to be active
as you usually are in daily life. Also, take the chance to get used to wearing FitBit
every day. After one week, you will take the intake interview B during which we
will help you install the HeartSteps mobile application and give you the instruction
on how to use it. You may raise any questions and concerns during this
interview.

6. How should I schedule an an exit interview?


You can schedule an exit interview with our researchers through phone or email
within 2 weeks before the study comes to an end. If you forget to do so, our
researchers will contact you a week before the study ends to schedule an
appointment for exit interview.

7. How long will the exit interview take? What will be discussed?
The exit interview will take place after the 6-month study is completed. During the
interview, we will ask you for some feedbacks and sum up the study. All the
devices will be collected during this time.

8. What if I cannot attend the scheduled interview? Do I need to reschedule


my interview appointment?
If you cannot make it to the scheduled meeting, dont worry! Just give us a phone
call to inform us and reschedule the interview. We appreciate that you contact us
24 hours ahead of the appointment.

9. What should I bring to the intake interview and exit interview?


For the intake interview session A, you do not need to bring anything in
particular. For the session B, remember to bring your fully-charged iPhone (or
you can also bring a charger in case the battery runs out) with you so that we can
install the HeartSteps app for you.
For the exit interview, please bring back the FitBit device and your iPhone.

10. What information about me could be seen by the researchers or by other


people?
Participating in the study (Signing the consent form) gives the researchers your
permission to obtain, use, and share information about you for this study, and is
required in order for you to take part in the study. Information about you may be
obtained from any hospital, doctor, and other health care provider involved in
your care, including:
Hospital/doctor's office records, including test results (X-rays, blood tests,
urine tests, etc.)
All records relating to your condition, the treatment you have received, and
your response to the treatment
Demographic information
Personal information
Other information

11. How is my confidentiality protected?


We will take a number of steps to protect your privacy and confidentiality.
First, any personally-identifiable information (e.g., your name) will be
removed from all of your data after the study, and the data will only be linked with
your participant ID. All analyses will also use aggregate data. For example,
analyses of location will only be run on categories of Home, Work, and
Other, not actual addresses or locations. Your de-identified data will be stored
separately from a file that links your personal information and your participant ID,
and documents with this link will be kept in a locked filing cabinet to which only
the members of the study staff will have access. These files will also be
destroyed after the research is complete.
Second, all data collected will be kept on secure, restricted access servers
that have been approved by the University of Michigan for the storage of health
and other sensitive information. The servers are behind a firewall, under intrusion
monitoring, and will be made accessible only to the members of the study team.
Similarly, all data in paper form (e.g., surveys) will be stored in locked filing
cabinets that only members of the study team can access.
Third, to help protect data on your personal mobile phone, our study team is
available at the initial in-person session to help you add password-protection to
your phone. Password protection makes it highly unlikely that any unauthorized
person could gain access to your data, as iPhones security model automatically
encrypts all data stored on a password-protected phone.
Fourth, at any point during our in-person interview you may request that
audio recording be turned off at any time should you have any concerns about
anything you want to say being captured on tape. Similarly, you can skip any
survey or phone-based self-report question or refuse to answer any interview
question with which you feel uncomfortable.

12. Where can I find documented information of this study?/ Is this study
documented by the ClinicalTrials.Gov website?
This study is documented by the ClinicalTrials.Gov website publicly. You can
check detailed information about this study through the link: / Yes! You can
access recorded information of this study through the link below:

In-study FAQ
1. How should I know my daily prescribed activity goal?
When you complete the cardiac rehab program, your physiologist will tell you a
prescribed activity goal, and you can input that information into the HeartSteps
app and it will be displayed on the dashboard. If you have not discussed about it
with your physiologist, then just indicate an activity goal which you feel
comfortable with.

2. What if I cant/dont want to follow one of the messages suggestions?


Thats okay - each message is only a suggestion! Were working to make each
message accessible to you and appropriate for your context, but they wont be
perfect every time. Do us a favor, though, and press the messages thumbs
down icon to tell us that you dont like the message or that it needs to be
improved.
3. What if I am on a travel or under any circumstances where I cannot follow
the messages suggestions for a period of time?
If you are on a trip or under any circumstance that you cannot follow most of the
messages suggestions as you usually do, please turn the Vacation mode on
and indicate how many days you will be away in the app. The number of days
you take off will be added to the end of the study to extend it to 6 months. Our
researchers will send you an email to confirm the extension once we notice that
the vacation mode is on.

4. What if I want to change the time to receive the activity messages and
weekly activity planning survey?
You can definitely adjust the time to receive message suggestions in the settings!

5. What if I cannot see the text clearly on the screen?


You can definitely adjust that! Go to the settings in iPhone and enlarge the text
size.

6. What if I become sick or injured?


Oh no! If you are able to do so, we appreciate that you continue to wear the
device, rate the messages, and complete the weekly plan, as these provide us
with important data. One of the survey questions you might receive even includes
a place to indicate that you are sick. If you are unable to follow the suggestions or
feel that responding to the suggestions is a burden, we suggest you turn on the
Vacation mode. However, if health issues become so severe that they prevent
you from continuing with the study, please do not hesitate to contact us at ***.

7. What if my cardiac problems relapse or I develop new symptoms during the


study?
If any worsening or new symptoms shows up, which may lead to potential risks
including minor and self-limited musculoskeletal complaints, as well a possibility
of dyspnea or angina as a result of physical activity, please contact us at ***
immediately. At the same time, we suggest you speak with your health provider
about your situations.

8. What if I delete the HeartSteps app accidentally? How do I reinstall the


application?
Dont worry. If that happens, please call us immediately at (734) 392-8551 so we
can help you get it installed and started again.

9. What if the FitBit device stops working?


Please check if the FitBit device runs out of battery and needs to be charged first.
If it powers off but you cannot charge it immediately, you can turn on the
Vacation mode temporarily until you are able to charge it. If it still does not work
after charging, please contact us immediately at *** or ***.com for
troubleshooting.

10. What if I lose/damage the FitBit device, the charging device or my iphone?
These things happen! Please contact us immediately at (734) 392-8551 or
heartstepsum@gmail.com so that we can tell you what to do next step.

11. What if I want to drop from the study for personal reasons?
We understand and respect your decision! Please contact us via phone or email
to make the request.