COPDNCT04483154
Perry Virtual - A Prospective and Observational Rural Health Trial
An observational study of COPD and Arrhythmia, run by Coala Life, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COPD, Arrhythmia, Murmur, Heart
- What is being tested?
- Coala Heart Monitor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: Rural population with chronic illnesses and high admission rates
Who may be able to join
- 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)
Who cannot join
- Subjects with Pacemaker, ICD or Implanted Loop Recorder
- Subjects with no experience in using Smartphones and Apps
- Vulnerable Subjects (prisoners, elderly with decisional incapacity)
Trial locations and contacts
1 site in 1 country.
Martha Wilsdorf, RN contact
United States1 site, 1 recruiting
- Recruiting
Perry Community Hospital
Linden, Tennessee, 37096
Liane Parker, RN, LianeP@perrycommunityhospital.org
About this study
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.
Read the 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
- Being tested
- Coala Heart Monitor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Arrhythmias, Cardiac, Heart Murmurs, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coala Heart MonitorDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing admission rates
Measured: 6 months
Reduction in use of medications
Measured: 6 months
Increased quality of life
As measured by Rand-36
Measured: 6 months
Improved clinical management
Measured: 6 months
Secondary outcomes (2)
Show the value of using Coala Heart Monitor in rural care - patients
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coala Life, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Huneycutt, MD, Principal investigator, Perry Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483154
- Sponsor's protocol ID
- #20-PCHO-101
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perry Virtual - A Prospective and Observational Rural Health Trial
- ClinicalTrials.gov ID
- NCT04483154
- Acronym / sponsor ID
- #20-PCHO-101
- Conditions
- COPD, Arrhythmia, Murmur, Heart, Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Coala Life, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Rural population with chronic illnesses and high admission rates
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Subjects with Pacemaker, ICD or Implanted Loop Recorder
- Subjects with no experience in using Smartphones and Apps
- Vulnerable Subjects (prisoners, elderly with decisional incapacity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coala Heart MonitorThe 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. | Device | – |
Primary outcome
Reducing admission rates
Time frame: 6 months
Reduction in use of medications
Time frame: 6 months
Increased quality of life
Time frame: 6 months
As measured by Rand-36
Improved clinical management
Time frame: 6 months
2 secondary outcomes
Show the value of using Coala Heart Monitor in rural care - patients
Time frame: 6 months
Show the value of using Coala Heart Monitor in rural care - providers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Wilsdorf, RN contact
David Huneycutt, MD principal investigator
Perry Community Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Arrhythmia, run by Coala Life, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina Lepsky-Perla, MSc (931-589-8943, ValentinaL@PerryCommunityHospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing admission rates (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.