A home-based clinical trial undertaken in part by researchers at the Scripps Translational Science Institute (STSI) has found that wearable mobile health devices enhanced the rate of diagnosis of atrial fibrillation (AFib) hidden heart condition.
AFib, an abnormal heart rhythm characterized by rapid and irregular beating of the atria, is claimed to increase the risk of stroke fivefold.
The study found that by catching AFib in people who are at risk but might have gone undiagnosed, the mobile health (mHealth) devices lead to more people receiving critical preventive therapies.
STSI director of digital medicine and an associate professor at The Scripps Research Institute (TSRI) Steven Steinhubl said the study shows an almost threefold improvement in the rate of diagnosis of AFib in those actively monitored compared to usual care.
“Timely diagnosis of AFib more effectively can enable the initiation of effective therapies and help reduce strokes and death,” Steinhubl said.
The study has been undertaken by STSI researchers in partnership with Aetna’s Healthagen Outcomes unit and Janssen Pharmaceuticals using the FDA approved wireless iRhythm Zio®XT patch for ECG screening.
The study population included members of the Aetna fully insured commercial and medicare health plans.
Eligible members were identified using Aetna’s data sets depending on clinical characteristics related with a potential increased incidence of AFib.
The members were invited to take part in the study via a nationwide email outreach campaign that then allowed interested participants to enroll through a web-based digital consent process.
STSI said all of the study data was participant-generated, with individuals self-applying the wearable sensor they received in the mail and returning it to iRhythm for analysis once they had worn the patch for up to two weeks.
The generated data was also returned to the monitored participants and, with their approval, to their physicians.
A total of 5,214 individuals were included in the one-year analysis, with a third being assigned to the monitored cohort and the rest being observational controls. AFib was newly diagnosed in 6.3% of the monitored participants and in 2.4% of the controls.
Steinhubl said it is the first study to describe the early term clinical consequences of active ECG screening.
STSI said by reviewing claims data, the researchers observed that active monitoring was associated with increased initiation of anticoagulant and antiarrhythmic therapies.