Scripps Translational Science Institute is collaborating with Aetna and Janssen Pharmaceuticals in a clinical trial to determine if remote monitoring using wearables can spot asymptomatic Atrial Fibrillation — a condition linked to more than 20 percent of ischemic strokes.
The study will use a single lead electrocardiogram monitoring through iRhythm Technologies‘ wearable Zio XT Patch. It will also use a wristband sensor from Amiigo to record upper body activity, according to a description of the trial on ClinicalTrials.com. Although participants will be screened for four months, the estimated study completion date is not until September 2019.
The clinical trial is called mHealth Screening To Prevent Strokes, or mSToPS. The study will seek to answer the question: Can screening individuals in their homes using wearable sensor technology identify people with asymptomatic AFib more efficiently than regular visits to a primary care physician?
Participants for active monitoring will be recruited from Aetna’s commercial and Medicare programs — the goal is as many as 2,100. But another 4,000 people will be identified as observational controls. The study will focus on women older than 65 and men older than 55. Selection will be based on claims data that places them at a potentially increased risk of undiagnosed AFib, according to a statement from STSI.
Although all participants will wear the patch for the first and last two weeks of the study, some patients will be asked to wear the patch for the duration of the trial.
STSI Director Dr. Eric Topol said in the statement: “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.”
Dr. Steven Steinhubl, director of digital medicine at STSI and principal investigator of the trial said in the statement: “Once completed, it has the potential to truly change the practice of screening and markedly improve outcomes.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
More than 750,000 hospitalizations occur each year because of AFib. The condition contributes to an estimated 130,000 deaths each year. The death rate from AFib as the primary or a contributing cause of death has been rising for more than two decades, according to the Centers for Disease Control. Although AFib can indicate a risk of stroke, there are lots of people who have this condition but have not been diagnosed. That’s spurred the use of wearables, remote monitoring and other approaches to improve how patients are diagnosed and treated for the condition.
iRhythm was founded in 2006 to better identify patients suffering from an arrhythmia who were not being diagnosed, either because of limitations in available devices or in the processes required to initiate and monitor patients for arrhythmia.
