Perry Virtual - A Prospective and Observational Rural Health Trial
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedJuly 24, 2020
July 1, 2020
6 months
July 20, 2020
July 23, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
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
6 months
Interventions
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.
Eligibility Criteria
Rural population with chronic illnesses and high admission rates
You may qualify if:
- 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)
You may not qualify if:
- Subjects with Pacemaker, ICD or Implanted Loop Recorder
- Subjects with no experience in using Smartphones and Apps
- Vulnerable Subjects (prisoners, elderly with decisional incapacity)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coala Life, Inclead
Study Sites (1)
Perry Community Hospital
Linden, Tennessee, 37096, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Huneycutt, MD
Perry Community Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 23, 2020
Study Start
August 1, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
July 24, 2020
Record last verified: 2020-07