A virtual randomized trial launching this month will investigate whether a collaboration between a new heart health app, a medication adherence program, and an Apple Watch can accelerate the diagnosis of cardiovascular events, increase healthful lifestyles, and decrease strokes and death rates, all at one percent the cost of traditional clinical trials.
Janssen Pharmaceuticals, a member of the Johnson & Johnson Family of Companies, and Apple have collaborated to create a heart health program using the Apple Watch and a newly-designed app to improve the lives of the approximately 10 million Americans living with atrial fibrillation (AFib).
Clinicians, physicians, and scientists across Janssen, Apple, and Evidation Health, a patient interface health company, have collaborated to create HEARTLINE, a heart-health app designed to engage users through increased healthful living styles. Janssen is designing and running the study and Apple and Janssen collaborated on the app. Other outside groups have participated as well.
The randomized trial is designed to determine if wearable technology can detect AFib, if the app can successfully motivate users to follow an active, healthful lifestyle and boost patient compliance to prescribed medicine. Researchers also hope to answer whether anti-coagulants can improve outcomes following an AFib diagnosis, if asymptomatic patients with AFib can improve outcomes with anti-coagulants, whether these medications prevent strokes in all patients, if all irregular heartbeats necessitate medication, and whether these drugs can have negative effects.
“This is a trial of technology, human behavior, and drugs,” says C. Michael Gibson, an interventional cardiologist, CEO of the non-profit BAIM Research Institute at Harvard Medical School, Harvard professor, and co-chair of the HEARTLINE study. At 150,000 participants, Gibson says this is the largest randomized clinical trial in medicine to date. The actual study is completely virtual, with no required doctor appointments, hospital visits, or contact with clinical researchers, therefore slashing its price tag. At one percent the cost of a traditional clinical trial, Gibson calls it a “landmark trial.”
Five million Americans are currently diagnosed with AFib, some of whom are under-treated. Another five million may be living with it undiagnosed, which can lead to clot formation, strokes, and death.
“This collaboration brings together Johnson & Johnson’s depth of expertise and long heritage in treating cardiovascular disease with Apple’s experience in utilizing cutting-edge technologies to improve the lives of consumers,” says Paul Burton, Vice President, Cardiovascular and Metabolism Medical Affairs at the Janssen Pharmaceutical Companies. “Ultimately, we hope to improve the treatment of cardiovascular disease and identify ways to prevent it.”
The first year of the three-year study will focus on recruitment through advertisements, word-of-mouth, and awareness of the study. Gibson is vitalizing enrollment through his 450,000 twitter followers and 50,000 fellow cardiologists on clinicaltrialresults.org, which he founded.
Any American aged 65 and older can participate regardless of medical history; the open access allows for a more diverse participation. A majority of the participants do not have AFib and are not on medication.
Everyone will need an iPhone for the app and communication; three-quarters of participants will be selected randomly to wear watches. If they don’t have a watch, they can purchase one after entering the study; those on limited incomes will be offered watches at reduced costs. “We want a broad, inclusive enrollment,” says Burton. “We want to ensure the study is accessible to anyone who is interested.”
All participants, with or without the watch, are required to use the HEARTLINE app, which posts interactive healthful living ideas and is configured to entice users to want to use it. For example, the app measures how much a person stands and encourages people to stand and move around every hour, reminding the user this is good for his/her health.
“Apple is expert at designing consumer-friendly apps that make them want to use it,” says Burton. “People want to have healthy retirements. They want to be well. In the Beta test, they liked it and wanted to use it.”
The watch uses technology to monitor blood flow that converts to heart rate and rhythm. It will check the users’ resting heart rhythms multiple times a day; if it finds frequent irregular rhythms, it will sound an alert alarm. The wearer can then put a finger on the watch crown, or winder, to do an ECG. It is up to the participant to contact a health professional for further evaluation. The researchers will know if the person has been hospitalized and why through Medicare insurance claims data.
Clinical data will be collected to monitor progress and for participants’ personal physicians to use as needed. An independent external steering committee of expert physicians and scientists will analyze it.
If, during the trial, a patient is diagnosed with AFib and is prescribed anti-coagulants, the trial researchers will try to track their therapy and follow their progress but will not interfere as to which drug or dosage. “Our intent is to help researchers improve clinical outcomes for people with AFib,” says Burton. “That’s the goal.”
As with all technology, the watch is not 100% infallible; a risk of false positives or negatives exists. However, Burton says Apple conducted its own Apple Heart study that validated the watch’s ability to accurately detect Afib. “It is a very robust tool to look for AFib with great sensitivity and specificity.”
“It is reasonable to think that wearing the watch will increase detection,” says Burton. “We are assuming those with the watch will have higher diagnoses of AFib. This could move the needle in clinical practice. We want to see if having this clinical paradigm—the app combined with the watch—results in increased detection and diagnosis. But we also want to decrease stroke and death rates.”
Designing innovative ways to update clinical research is an exhilarating yet daunting task, says Burton. The machinery, frameworks, and procedures built for clinical trials over the last 60-70 years must be retooled to accommodate digital communication, wearable devices, and clinical trial decentralization. “You can’t just change digital from paper, such as consent forms, and think the whole system will work for you. It is amazingly difficult to operationalize.”
After a year, Burton says the study will be reassessed to see if it is ready to expand globally. But perhaps the big question is if this technology can be successfully applied to other types of trials.
“We have enough patients to give it a shot to see if it improves the health of patients,” says Gibson. “Sometimes great ideas aimed at preventing something don’t pan out. That’s why we have studies.”
