MedTrace Logo

Perry Virtual - A Prospective and Observational Rural Health Trial

NCT04483154 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-07-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Coala Life, Inc

    lead INDUSTRY

Principal Investigators

  • David Huneycutt, MD · Perry Community Hospital

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-02-28
Completion
2021-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04483154 on ClinicalTrials.gov