Clinical trial NCT04483154: Perry Virtual - A Prospective and Observational Rural Health Trial
Official title: Perry Virtual - A Prospective and Observational Rural Health Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Arrhythmia
Murmur, Heart
Chronic Disease
Lead sponsor: Coala Life, Inc
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rural population with chronic illnesses and high admission rates

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* History of frequent admissions, defined as minimum of 2 during the last 6 months
* ICD diagnosis for COPD and/or hypertension and/or diabetes and/or cardiovascular diseases
* Patient has Smartphone or Tablet, as well as Internet connection in their homes (or 3G/4G/5G connection)

Exclusion Criteria:

* Subjects with Pacemaker, ICD or Implanted Loop Recorder
* Subjects with no experience in using Smartphones and Apps
* Vulnerable Subjects (prisoners, elderly with decisional incapacity)

Primary outcomes:
measure: Reducing admission rates
timeFrame: 6 months
measure: Reduction in use of medications
timeFrame: 6 months
measure: Increased quality of life
timeFrame: 6 months
measure: Improved clinical management
timeFrame: 6 months
Secondary outcomes:
measure: Show the value of using Coala Heart Monitor in rural care - patients
timeFrame: 6 months
measure: Show the value of using Coala Heart Monitor in rural care - providers
timeFrame: 6 months
Other outcomes:
Locations:
city: Linden
country: United States
facility: Perry Community Hospital
state: Tennessee
Study officials:
affiliation: Perry Community Hospital
name: David Huneycutt, MD
role: PRINCIPAL_INVESTIGATOR
References: