Stanford Medicine Newsletter Updates For the Local Community

 

Smartphone app for heart health

Feedback for users, innovative tool for researchers

Cardiologists Alan Yeung (left) and Michael McConnell are using the MyHeart Counts app to collect data about physical activity and cardiac risk factors in a large-scale study of the prevention and treatment of heart disease.

   

In March, the School of Medicine launched a first-of-its-kind iPhone app that enables users to help advance the understanding of the health of the human heart. The free MyHeart Counts app uses the new Apple ResearchKit framework to help assess each user’s heart health and provide information on how to improve it. The app represents an entirely new approach to medical research, making it easier for scientists to study health and disease by allowing them to gather 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 relating to their cardiac risk factors and will get feedback on their chances of developing heart disease and an estimate of their “heart age.” Among other things, the researchers will study what factors motivate people to improve their heart health and will provide users with coaching tips. Michael McConnell, MD, professor of cardiovascular medicine at Stanford, is the principal investigator for the MyHeart Counts study.

Stanford Medicine’s MyHeart Counts is one of the first five apps to use Apple’s ResearchKit framework. With its release as open-source software in April, do you expect to see other researchers jumping onboard using this new platform?

Absolutely. One of the key academic goals of developing these ResearchKit apps was to make it much easier for other researchers to implement additional studies. This research “tool kit” Stanford and other institutions helped to develop includes doing consent, surveys and research tasks through a smartphone, which provides the building blocks for designing new research studies. Releasing ResearchKit as open source makes it easier and will help spread this kind of research to other phone operating systems.

Since the MyHeart Counts app was released in March, almost 40,000 users have downloaded the app and consented to participate in the study. How does this time frame and number of participants compare with recruitments for medical research trials in general? What do you hope to see in the future?

There have been larger research studies, particularly national efforts to study populations, but we believe enrolling this many participants in such a short time frame is unprecedented. We very much appreciate the interest in 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.

Participants are asked to keep their iPhone with them as much as they can during a seven-day period that measures their physical activity. What happens when the participant cannot keep the phone on them during activities such as swimming?

The iPhone has a motion chip and sensors that measure activities 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. While you only need an iPhone to participate in MyHeart Counts, the app does collect activity data from wearable devices that are linked to the app on the iPhone, including the Apple Watch.

Could you discuss the significance of the consent process for the future of medical research?

We believe this new “e-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. We greatly appreciate the efforts of John Wilbanks from Sage Bionetworks in working with all the institutions involved in ResearchKit to develop this consent process, as well as the input from our own bioethics group and Institutional Review Board.

How are you ensuring that participants stay anonymous and that data won’t be hacked or fall into the wrong hands?

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. 

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?

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 provide personalized feedback about individual behaviors and risk based on the American Heart Association’s “Life’s Simple 7” guidance.

Will the MyHeart Counts study be available on devices other than Apple’s now that the platform is open-source software?

The open-source release of ResearchKit will certainly speed the ability to provide MyHeart Counts and similar research studies on other smartphones. We estimate that will occur in late 2015 or early 2016. 

What kind of advice would you give to other researchers attempting to use this new platform for recruitment for medical research trials?

There have been technical bumps in using a smartphone app for research—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.

 

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