Scripps Launches Wearables-Powered Population Health Study

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A team of researchers working at Scripps Translational Science Institute are launching a new clinical trial that will remotely monitor patient heart rates in order to measure the prevalence of undiagnosed atrial fibrillation, or an irregular heart beat, in the general population. Called the mHealth Screening To Prevent Strokes study, awkwardly abbreviated as mSToPS, the study aims to determine whether routine, at-home heart-rate monitoring is a financially and technically viable way of improving atrial fibrillation diagnosis in high-risk patient populations.

Researchers will recruit a total of 6,100 participants before the study commences. Enrollment will be limited to women over 65 and men over 55 that are found to be at high risk for having undiagnosed atrial fibrillation. Twenty-one hundred participants will be outfitted with one of several home-monitoring technologies, while the remaining 4,000 will act as a control group. Most of the 2,100 patients selected for home monitoring will be sent home with a transdermal patch-based sensor by iRhythm Technologies. The patch is outfitted with a single lead ECG sensor that is water resistant and can be worn 24 hours a day for up to two weeks. Scripps worked with the startup behind the patch on a previous study, testing the device’s ability to diagnose atrial fibrillation when compared to a traditional Holter monitor. In that study, iRhythm’s patch outperformed the Holter monitor, accurately detecting 96 atrial fibrillation events compared to the Holter monitor’s 61. Researchers from that earlier study concluded, “Physicians who reviewed data from both devices reported reaching a definitive diagnosis 90 percent of the time when using the patch results and 64 percent of the time when using Holter monitor data.” A subset of participants in the new study will also be asked to wear the Amiigo wristband, a newer technology that was also designed to monitor heart rate. While participants wearing the iRhythm’s patch will only wear the device for the first and last two weeks of the study, participants using the Amiigo will be asked to wear the device as much as possible for the entire four-month study.

The CDC estimates that 30 percent of all atrial fibrillation cases remain undiagnosed despite routine preventative care. Atrial fibrillation itself is often asymptomatic, but an estimated 6 million people in the US have the condition, and it is associated with a five fold increased risk of stroke. An average of one in three people with atrial fibrillation will have a stroke within their lifetime.

Scripps is partnering with Aetna’s Innovation Lab and Janssen Pharmaceuticals during the trial.


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