Researchers at the Scripps Translational Science Institute (STSI) have launched a home-based clinical trial that uses wearable sensor technology to identify people with asymptomatic atrial fibrillation (AFib).
The mHealth Screening To Prevent Strokes (mSToPS) study will involve up to 2,100 participants who will be recruited for active monitoring through the Aetna Commercial Fully Insured and Medicare programs, and an additional 4,000 people will be identified as observational controls. Women over the age of 65 and men over 55 will be selected to participate based on information derived from claims data that places them at a potentially increased risk of undiagnosed AFib.
The study is a collaborative effort between STSI, Aetna’s Innovation Labs and Healthagen Outcomes, and Janssen Pharmaceuticals.During the four-month monitoring period, participants will undergo continuous single-lead electrocardiogram (ECG) monitoring using iRhythm Technologies’ ZIO XT Patch wearable sensor for the first two weeks and last two weeks of the monitoring period. Also, a subset of participants will be asked to monitor heart rate and rhythm characteristics using the Amiigo wristband monitor.
“This is a uniquely targeted and participant-centric trial that takes full advantage of digital technologies, including large medical data sets and wearable sensors,” said Steven Steinhubl, M.D., director of digital medicine at STSI and principal investigator of the mSToPS trial. “Once completed, it has the potential to truly change the practice of screening and markedly improve outcomes.”
The study is a collaborative effort between STSI, Aetna’s Innovation Labs and Healthagen Outcomes, and Janssen Pharmaceuticals.
According to the Centers for Disease Control and Prevention, as many as six million Americans live with AFib, which is an irregular heartbeat (arrhythmia) that can lead to a five-fold increased risk of stroke and other severe health-related complications.