Perry Virtual - A Prospective and Observational Rural Health Trial

NCT ID: NCT04483154

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-02-28

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.

Conditions

COPD; Arrhythmia; Murmur, Heart; Chronic Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Coala Heart Monitor

The Coala Heart Monitor (Coala Life AB, Sweden) is a CE and FDA-cleared device for real-time, remote monitoring of 2-lead ECG as well as heart and lung sounds. The Coala Heart Monitor automatically detects for 9 of the most common arrhythmias and has an integrated stethoscope for remote auscultation. It is paired wirelessly with the patient's smartphone and results are provided instantly both to patient and to connected provider in the cloud-based Coala Care portal.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coala Life, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Huneycutt, MD

Role: PRINCIPAL_INVESTIGATOR

Perry Community Hospital

Locations

Perry Community Hospital

Linden, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Valentina Lepsky-Perla, MSc

Role: CONTACT

ValentinaL@PerryCommunityHospital.org

931-589-8943

Martha Wilsdorf, RN

Role: CONTACT

MarthaW@perrycommunityhospital.org

Facility Contacts

Liane Parker, RN

Role: primary

LianeP@perrycommunityhospital.org

Other Identifiers

#20-PCHO-101

Identifier Type: -

Identifier Source: org_study_id