An FDA approved
wireless iRhythm Zio®XT patch was used for ECG screening in the study that was
conducted jointly by STSI researchers, Aetna's Healthagen Outcomes unit and
Janssen Pharmaceuticals, Inc.
‘In a first of its kind study, atrial fibrillation (a major risk factor for stroke) was diagnosed using a mobile health device; such active monitoring can initiate anticoagulant and antiarrhythmic therapies well ahead and help prevent the occurrence of strokes.’
The findings of the mHealth Screening To Prevent
Strokes (mSToPS) study were published in the
Journal of the
American Medical Association.
"Our study shows
an almost threefold improvement in the rate of diagnosis of AFib in those
actively monitored compared to usual care," says Steven Steinhubl, MD,
director of digital medicine at STSI and an associate professor at The Scripps
Research Institute (TSRI). "Timely diagnosis of AFib more effectively can
enable the initiation of effective therapies and help reduce strokes and
death."
Better
screening will aid in detecting AFib
AFib is a kind of
arrhythmia or irregular heartbeat that is a major risk factor for
stroke and also doubles the risk of death. As many as
six million Americans live with AFib. Once AFib has been diagnosed, the risk of
stroke in individuals can be cut down with effective therapies. However, since
a third of individuals with the disorder show no symptoms, and the lack of
effective screening prevents or delays diagnosis and treatment, it becomes
unavoidable sometimes to prevent stroke in people with AFib.
Digital medicine
technologies are innovative screening strategies that have the capability of
making clinical research more inclusive and participant-centric. Novel mobile
health (mHealth) devices monitor AFib more effectively and continuously without
interfering with routine activities.
The primary objective
of the mSToPS study was to determine whether asymptomatic AFib can be
identified more efficiently than routine care using wearable sensor technology.
The study compared outcomes of intermittent screening for AFib during regular
visits to a primary care physician with continuous, single-lead
electrocardiogram (ECG)
monitoring using a patch sensor at home.
Home-based
clinical research
The study population
consisted of members of the American managed
health care company, Aetna fully insured Commercial and Medicare health
plans. Aetna's data sets were used to identify eligible members based on
clinical characteristics associated with a possible increased incidence of
AFib. The interested participants enrolled through a web-based digital consent
process following a nationwide email outreach campaign.
The advantage of the
digital outreach and enrolment, and the home-based approach was that a person
could participate in the study regardless of their geographical location.
A
total of 5,214 individuals were included in the one-year analysis. One-third of
them were assigned to the monitored cohort and the rest were observational
controls. The monitored individuals received the wearable sensor by mail.
They self-applied the
sensor and self-generated all the data (participant-generated).
The sensor was
returned to iRhythm for analysis after two weeks of wearing the patch.
The generated data
from the sensor was returned to the monitored participants and, then forwarded
to their physicians after approval.
- AFib was newly diagnosed in 6.3
percent of the monitored participants and in 2.4 percent of the controls.
"This study
demonstrates the utility of a digital approach not only to diagnosing
asymptomatic AFib, but to the clinical research field as a whole," says
Steinhubl. "We hope that it will set a precedent for future real-world,
participant-centric clinical trials that leverage the power of digital medicine
technologies."
Clinical research
should use more digital tools to make it more participant-focused and reflect
the real world of those participants.
Atrial
Fibrillation
Typically, the
heart contracts and relaxes to a regular beat.
Atrial fibrillation is the most common type of
irregular heartbeat where the abnormal firing of electrical impulses causes the
upper chambers of the heart to beat irregularly or quiver instead of beating
effectively at a normal pace to move blood into the lower chambers.
A person might be diagnosed with AFib only upon physical examination as the
condition sometimes exhibits no symptoms. Some others might experience (apart
from an irregular heartbeat), a fluttering or thumping in the chest,
shortness of breath, faintness, fatigue (when exercising), dizziness, weakness,
sweating or chest pain.
Many patients are unaware that AFib is a severe
condition or that having AFib increases their risk for stroke or heart-related hospitalizations or death
. In reality, AFib doubles the risk of heart-related
deaths and is associated with a 5-fold increased risk for stroke.
A stroke
results when a clot breaks off, enters the bloodstream and lodges in an artery
that leads to the brain. About 15-20 percent of people who have strokes have
AFib. Hence,
treatment
of the condition can save lives and lower risks. Patients
diagnosed with this condition are put on blood thinners to prevent the
occurrence of clots.
Reference :- Treatment and Prevention of Atrial Fibrillation - (http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/Treatment-and-Prevention-of-Atrial-Fibrillation_UCM_423778_Article.jsp#.W0Rmj2AzaK4)
Source: Medindia
