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.

Study Overview

• Status: Unknown
• Conditions: Chronic Disease; Arrhythmia; COPD; Murmur, Heart
• Intervention / Treatment: Device: Coala Heart Monitor

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Linden, Tennessee, United States, 37096
      • Recruiting
      • Perry Community Hospital
      • Contact: Liane Parker, RN; Email: LianeP@perrycommunityhospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Rural population with chronic illnesses and high admission rates

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reducing admission rates		6 months
Reduction in use of medications		6 months
Increased quality of life	As measured by Rand-36	6 months
Improved clinical management		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Show the value of using Coala Heart Monitor in rural care - patients		6 months
Show the value of using Coala Heart Monitor in rural care - providers	The cloud-based Coala Care platform enables patient data to be shared and accessed efficiently with affiliated specialists. Show how this helps improve clinical management and healthcare processes.	6 months

Collaborators and Investigators

• Sponsor: Coala Life, Inc
• Investigators: Principal Investigator: David Huneycutt, MD, Perry Community Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Heart Murmurs
• Other Study ID Numbers: #20-PCHO-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No