5 Questions: A three-month checkup of MyHeart Counts

In March, the School of Medicine launched MyHeart Counts, a first-of-its-kind iPhone app that enables users to participate in a large-scale study of the human heart. The app assesses each user’s cardiovascular health and provides information on how to improve it. Researchers involved with the MyHeart Counts study will investigate, among other things, what factors motivate people to improve their heart health.

MyHeart Counts is one of the first apps to use Apple’s ResearchKit framework, which is designed to make it easier for scientists to study health and disease by allowing them to gather more real-world participant data through the iPhone. The app collects data about participants’ physical activity using the smartphone’s built-in motion sensors. Participants also are asked to respond to surveys and questions related to their cardiac risk factors. They get feedback on their chances of developing heart disease and an estimate of their “heart age.”

Recently, writer Tracie White checked in with Michael McConnell, MD, a professor of cardiovascular medicine at Stanford, about how things with the app and the study are progressing. He is the study’s principal investigator.

Q: Since the MyHeart Counts app was released, almost 40,000 users have downloaded it and consented to participate in the study. How does this compare with recruitments for medical research trials in general?

McConnell: There have been larger research studies, particularly national efforts to study their populations, but we believe enrolling this many participants in such a short time frame is unprecedented. We very much appreciate the interest of the public for participating in medical research and are excited to offer this new approach that clearly facilitates participation. For the future, we hope to learn from our research participants — from both their feedback and their data — on how best to engage with them and learn the most from our research.

Q: Participants are asked to keep their iPhone with them as much as they can during a seven-day period. What happens during activities such as swimming when they can’t carry a phone?

McConnell: The iPhone has a motion chip and sensors that measure your activities without draining the battery, but only if the phone is with you. The MyHeart Counts app captures these data, plus checks with you daily during the seven-day assessment to enter any activities that were not captured by the phone, such as swimming. While you only need an iPhone to participate in MyHeart Counts, the app does collect activity data from wearable activity devices that are linked to the Health app on the iPhone, including the Apple Watch.

Q: Have you been happy with how the consent process is working?

McConnell: We have been very happy with the consent process and have received positive feedback from both users and other researchers. We greatly appreciate the efforts of John Wilbanks from Sage Bionetworks in working with all the institutions involved in ResearchKit to develop this “e-consent” process, as well as the input from our own bioethics group and institutional review board. We believe this new consent process gives the participant study information in a more user-friendly way, as well as more time to review and decide. These are critical elements to informed consent, but we will need to understand in more depth how participants respond to this format. The goal is to broaden the ability for people to participate in medical research in which they are interested.

Q: When the app was first released, it was announced that behavior modification methods would be studied. When do you expect this phase of the app to be rolled out and what types of methods will be used?

McConnell: Yes, healthy behaviors are critical to preventing heart disease and stroke, so the MyHeart Counts app will study which motivational tools are most helpful. This will follow the second activity and fitness assessment, which occurs after three months. The initial approach will be empowering participants with more personalized feedback about their individual behaviors and risk, based on the American Heart Association’s “Life’s Simple 7” guidance.

Q: How are you ensuring that participants stay anonymous and that data won’t be hacked or fall into the wrong hands? Also, have there been bumps along the road as the app has been rolled out?

McConnell: We follow the best data security protocols, such as encrypting the data as it leaves the phone and using a secure server to receive the data. Also, personal identifying information is separated from the research data so that only anonymous data goes to a special secure server for analysis. While we employ all these security measures, we simply cannot guarantee that any system is 100 percent foolproof.

There have been technical bumps in using a smartphone app for research. This is clearly one of the challenges faced by the first group of ResearchKit apps. We actively listen to user feedback and have made improvements to the app; future researchers will benefit from what we’ve learned. The main advice I would give to other researchers is to be straightforward with your participants that there may be technical issues, even for the next generation of ResearchKit apps, and to ask for feedback to help improve the technology as this new approach to research continues to evolve.