COPD Clinical Trial
Official title:
Perry Virtual - A Prospective and Observational Rural Health Trial
The principal objective of the study is to determine if patient-empowered, real-time and
home- based patient monitoring of vital parameters can lead to:
- Reduction in admission rates and improved clinical management of chronically ill
patients
- Reduction in use of medications
- Reported quality of life
A minimum of 100 patients will be recruited, monitored and observed over 6 months from home
with the Coala Heart Monitor. The study population will be representative of rural,
high-risk, Medicare (65+ of age) subjects with chronic conditions and will be recruited by
the Perry Community Hospital in Linden, TN.
More than 46 million Americans, or 15% of the US population, live in rural areas. According
to the Center of Disease Control (CDC), rural Americans face numerous health disparities and
more likely to die from heart disease, cancer, unintentional injury, chronic lower
respiratory disease, and stroke than their urban counterparts. A series of studies from CDC
have drawn attention to the significant gap in health between rural and urban Americans.
Heart palpitations account for over 70 million US primary care visits every year and is the
second most common reason for visiting a cardiologist in the US. With the increased
availability of single-lead consumer ECG solutions increasing the demand on providers, home-
based solutions are needed enabling cost-effective, prescription-based and diagnostic
monitoring solution are needed.
The Coala Heart Monitor was introduced in Scandinavia in 2017 and in the US in 2019. The
device is connected to the patient's smartphone and records ECG as well as heart and lung
sounds.The complementary cloud-based data analytics platform, Coala Care, analyzes the full
disclosed, high resolution data using smart algorithms to detect cardiac rhythm deviations by
advanced pattern recognition including real-time AFib detection based on P-waves and R-R
dispersion. The heart sounds are further transformed into high-fidelity phonocardiograms
(PCG) for murmur detection in real time. Heart and lung sounds can be listened to remotely.
Both health care providers and patients can view the results - the former via the HIPAA-
compliant online portal and the latter via the Coala smartphone app - and physicians can send
secure private messages immediately if something requires a follow-up.
The COVID-19 Coronavirus pandemic has quickly transformed cardiovascular medicine with shift
from traditional hands-on care to remote hands-off telemedicine to keep patients and their
medical staff safe.
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