Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, is partnering with Apple to study atrial fibrillation and how wearable technologies can help people identify afib to reduce the likelihood of an adverse health outcome.
The virtual research study, called the Heartline Study, will look at whether the use of the Heartline Study app on an iPhone, in combination with the electrocardiogram app and the irregular rhythm notification feature on Apple Watch, can reduce the likelihood of stroke and improve health outcomes with the earlier detection of afib.
Health technology company Evidation Health also is a collaborator on the study, providing the technology and operations that enable the Heartline Study app and study experience for participants.
The virtual study is open to consumers age 65 or older who have original (traditional) Medicare. Study participants also must own an iPhone 6s or a later model and agree to provide researchers access to their Medicare claims data.
Afib is a common form of irregular heartbeat rhythm and the leading cause of stroke in the U.S. Up to 6 million Americans have afib, according to Janssen. The condition often has no symptoms, and patients may not learn of it until they suffer a serious cardiac event like a stroke or heart attack.
Johnson & Johnson’s Paul Butron, vice president of medical affairs, told CNBC's Chrissy Farr the study represents the largest randomized trial in the history of cardiovascular disease.
The study will span three years, and the goal is to recruit 150,000 people who will be randomly assigned into one of two groups.
One group will only use the Heartline Study app, which provides health education and tips. The second group will be given the Apple Watch, either as a loaner device or at a heavily subsidized price of $49 plus tax, Farr reported.
The collaboration with Johnson & Johnson is Apple's latest move to get more involved in healthcare.
The tech giant teamed up with Stanford Medicine on a research initiative looking into how the Apple Watch can identify users experiencing irregular heart rhythms and virtually connect them with a physician. In September, Apple launched a new Research app to enable researchers to collect and share data, along with three medical studies focused on hearing, women's health and heart rate and mobility.
“Heartline is a study that has the potential to fundamentally change our understanding of how digital health tools, like the ECG app and irregular rhythm notification feature on Apple Watch, could lead to earlier detection of AFib, helping patients understand and directly engage in their heart health, prompting potentially life-saving conversations with their doctors, and improving health outcomes,” said C. Michael Gibson, M.D., co-chair of the Heartline Executive Committee, professor of medicine at Harvard Medical School and CEO of the Baim Institute.
Through the app-based approach, the study will enable participants to engage in the study remotely using their iPhones and in some cases an Apple Watch, rather than traveling to a clinical trial site. This approach to conducting a clinical trial, if successful, could potentially save time and money.
The study will test out new models to break down some of the most common barriers to participation in clinical studies, according to Paul Burton, M.D., Ph.D., vice president, medical affairs, internal medicine at Janssen Scientific Affairs.
“Apple technology is making a meaningful impact on scientific research through the powerful capabilities of iPhone and Apple Watch, all with privacy at the center of the participant experience,” said Myoung Cha, Apple's head of health strategic initiatives.