- More than 2,000 California residents at risk of having an undetected irregular heartbeat will be fitted with wearable sensors to determine whether a home monitoring program can reduce their chances of suffering a stroke.
Some 6 million Americans are living with asymptomatic atrial fibrillation (AFib) and are five times more susceptible to sustaining a stroke, with one in every three experiencing a stroke in his or her lifetime, according to the Centers for Disease Control and Prevention. More importantly, as many as 30 percent of those living with AFib haven’t been diagnosed.
The mHealth Screening to Prevent Strokes (mSToPS) study, the brainchild of Scripps Health’s La Jolla-based Scripps Translational Science Institute, aims to equip healthcare providers with a real-time link to at-risk populations, so that strokes can be prevented or treated more quickly. The four-month study will focus on 2,100 recruited participants – women 65 and older and men 55 and older – who’ve been identified from Aetna Commercial Fully Insured and Medicare program claims data as having a higher than normal potential for undiagnosed AFib.
The participants will be fitted with Zio XT Patch wearable sensors for the first and last two weeks of the study, offering researchers a continuous single-lead electrocardiogram of each patient during that time. Some will also be given Amiigo wristbands and asked to wear the monitor as much as possible every day during the study.
Researchers hope the digital devices can replace the current standard of care, which focuses on regular checkups with a doctor who may or may not be able to detect AFib. Those deemed at risk are often hooked up to ECG monitors for 30 to 60 days to check for irregular patterns. And while ECGs can easily and accurately diagnose AFIb, they’re expensive, time-consuming and cumbersome.
“Digital sensors are a vital part of the future of medicine,” Eric Topol, MD, the STSI’s director, said in a press release announcing the project. “The mSToPS trial has the potential to upgrade and refine our approach in screening for heart arrhythmias, and at the same time demonstrate the value of large, real-world clinical trials using an array of digital medicine technologies.”
“This is a uniquely targeted and participant-centric trial that takes full advantage of digital technologies,” added Steven Steinhubl, MD, STSI’s director of digital medicine and the study’s principal investigator. “Once completed, it has the potential to truly change the practice of screening and markedly improve outcomes.”
Steinhubl says the success of the project may very well hinge on how unobtrusive it is to those involved. “The starting point is to design the trial in as participant-centric manner as absolutely possible,” he said. “”That means minimizing anything that might impact their daily routine and keeping them in the communication loop on all aspects of the study.”
He noted researchers won’t even know if the participants wore their Zio patches until the end of the study, while those wearing Amiigo wristbands can be monitored in real-time.
“As mSToPS is designed as a pragmatic study to best inform us how to screen for asymptomatic AF, understanding the real-world usability of wearable patches and wristband devices will be one of the many important things to be learned from this study,” Steinhubl said.
With AFib identified as the most common form of cardiac arrhythmia in the U.S., affecting roughly one of every four adults over the age of 40, healthcare researchers have made it a popular subject of mHealth studies. Last year San Francisco-based AliveCor announced that it had gained U.S. Food and Drug Administration approval for an algorithm that detects AFib; the algorithm is now part of the company’s Heart Monitor platform, which includes a wearable monitor paired with a smartphone application.
In April of 2013, Australian researchers using AliveCor’s platform were able to identify 15 previously undiagnosed cases of AFib among a target population, using 30-to-60-second ECGs captured by the wearable monitor. More recently, researchers in Sweden screened more than 7,000 individuals aged 75 or 76, using a handheld ECG monitor for 30 seconds twice a day for two weeks, and discovered 3 percent had undetected AFib.
“Very few conditions are more appropriate for screening,” Steinhubl said.
Researchers in Japan, meanwhile, are taking an even more consumer-focused approach to AFib detection. The Keio University School of Medicine has just launched a clinical research project that uses the iPhone, Apple Watch and Apple’s ResearchKit platform to collect data from participants. Users are asked to answer questions about AFib and their quality of life through the university’s new Heart & Brain app, as well as submit data collected by sensors in the phone or watch. They’re also asked to take a simple motor assessment test that researchers said may be useful in detecting a stroke.