Next for Apple Watch: ‘pragmatic’ clinical trial with J&J to track heart health

Now maybe we’re getting somewhere.

Results from a study conducted by Stanford researchers working with Apple showed that using the Apple Watch to detect atrial fibrillation probably won’t cause an epidemic of worrisome diagnoses. But it didn’t really answer most of the questions doctors or consumers have about using the watch in this way.

But Apple is taking the next step, teaming with Johnson & Johnson to a conduct a study of 180,000 people over the age of 65 to get a better understanding of the Apple Watch’s impact on health. The study will randomly assign patients to either receive the watch and a digital app to keep them engaged, or nothing. Dr. C. Michael Gibson, president and CEO of the Baim Institute for Clinical Research and a Harvard professor, will co-chair the study, called HEARTLINE.

The new study will first evaluate whether Apple’s technology for identifying atrial fibrillation based on a person’s pulse matches with results from the EKG app in the latest version of the Apple Watch — and see whether more atrial fibrillation is diagnosed in patients who receive the watch and the app.

Then the study will compare whether getting the watch has an effect on preventing stroke, heart attack, and death from any cause. The results will indicate whether for people at higher risk of developing atrial fibrillation, because they are old, that the Apple Watch’s atrial fibrillation tech is good for health. “The hard endpoint will look at good things and bad things that can happen to the patient,” Gibson said in an interview.

Typically, clinical trials use their own research infrastructure to track how patients do, but the HEARTLINE trial will plug into insurance claims databases to track patients. This approach, called a pragmatic clinical trial, could be cheaper and more efficient than the way studies are conducted now, without sacrificing the clarity and certainty that comes from having a control group in a study. But this is also risky: Using insurance claims data this way is new and untested.

“It’s certainly a vast and gross departure form the bricks and mortar model,” said Gibson. “This is one of the most exciting things, the idea that you’re going to find participants through the media, the news, potentially through insurers and even health care providers.”

Why is J&J interested? It co-markets the blood thinner Xarelto, used in some patients with atrial fibrillation to reduce the risk of stroke. And it is developing other stroke-preventing drugs. But the company has also expressed interest in getting into digital clinical trials, and partnering with Apple is not a bad way to get started.

The HEARTLINE study is expected to begin in late 2019.

https://www.statnews.com/2019/03/16/apple-watch-johnson-johnson-clinical-trial/