<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04483154</url>
  </required_header>
  <id_info>
    <org_study_id>#20-PCHO-101</org_study_id>
    <nct_id>NCT04483154</nct_id>
  </id_info>
  <brief_title>Perry Virtual - A Prospective and Observational Rural Health Trial</brief_title>
  <official_title>Perry Virtual - A Prospective and Observational Rural Health Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coala Life, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coala Life, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The principal objective of the study is to determine if patient-empowered, real-time and&#xD;
      home- based patient monitoring of vital parameters can lead to:&#xD;
&#xD;
        -  Reduction in admission rates and improved clinical management of chronically ill&#xD;
           patients&#xD;
&#xD;
        -  Reduction in use of medications&#xD;
&#xD;
        -  Reported quality of life&#xD;
&#xD;
      A minimum of 100 patients will be recruited, monitored and observed over 6 months from home&#xD;
      with the Coala Heart Monitor. The study population will be representative of rural,&#xD;
      high-risk, Medicare (65+ of age) subjects with chronic conditions and will be recruited by&#xD;
      the Perry Community Hospital in Linden, TN.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than 46 million Americans, or 15% of the US population, live in rural areas. According&#xD;
      to the Center of Disease Control (CDC), rural Americans face numerous health disparities and&#xD;
      more likely to die from heart disease, cancer, unintentional injury, chronic lower&#xD;
      respiratory disease, and stroke than their urban counterparts. A series of studies from CDC&#xD;
      have drawn attention to the significant gap in health between rural and urban Americans.&#xD;
&#xD;
      Heart palpitations account for over 70 million US primary care visits every year and is the&#xD;
      second most common reason for visiting a cardiologist in the US. With the increased&#xD;
      availability of single-lead consumer ECG solutions increasing the demand on providers, home-&#xD;
      based solutions are needed enabling cost-effective, prescription-based and diagnostic&#xD;
      monitoring solution are needed.&#xD;
&#xD;
      The Coala Heart Monitor was introduced in Scandinavia in 2017 and in the US in 2019. The&#xD;
      device is connected to the patient's smartphone and records ECG as well as heart and lung&#xD;
      sounds.The complementary cloud-based data analytics platform, Coala Care, analyzes the full&#xD;
      disclosed, high resolution data using smart algorithms to detect cardiac rhythm deviations by&#xD;
      advanced pattern recognition including real-time AFib detection based on P-waves and R-R&#xD;
      dispersion. The heart sounds are further transformed into high-fidelity phonocardiograms&#xD;
      (PCG) for murmur detection in real time. Heart and lung sounds can be listened to remotely.&#xD;
&#xD;
      Both health care providers and patients can view the results - the former via the HIPAA-&#xD;
      compliant online portal and the latter via the Coala smartphone app - and physicians can send&#xD;
      secure private messages immediately if something requires a follow-up.&#xD;
&#xD;
      The COVID-19 Coronavirus pandemic has quickly transformed cardiovascular medicine with shift&#xD;
      from traditional hands-on care to remote hands-off telemedicine to keep patients and their&#xD;
      medical staff safe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reducing admission rates</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in use of medications</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Increased quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>As measured by Rand-36</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improved clinical management</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Show the value of using Coala Heart Monitor in rural care - patients</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Show the value of using Coala Heart Monitor in rural care - providers</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COPD</condition>
  <condition>Arrhythmia</condition>
  <condition>Murmur, Heart</condition>
  <condition>Chronic Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coala Heart Monitor</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Rural population with chronic illnesses and high admission rates&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of frequent admissions, defined as minimum of 2 during the last 6 months&#xD;
&#xD;
          -  ICD diagnosis for COPD and/or hypertension and/or diabetes and/or cardiovascular&#xD;
             diseases&#xD;
&#xD;
          -  Patient has Smartphone or Tablet, as well as Internet connection in their homes (or&#xD;
             3G/4G/5G connection)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with Pacemaker, ICD or Implanted Loop Recorder&#xD;
&#xD;
          -  Subjects with no experience in using Smartphones and Apps&#xD;
&#xD;
          -  Vulnerable Subjects (prisoners, elderly with decisional incapacity)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>David Huneycutt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Perry Community Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Valentina Lepsky-Perla, MSc</last_name>
    <phone>931-589-8943</phone>
    <email>ValentinaL@PerryCommunityHospital.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martha Wilsdorf, RN</last_name>
    <email>MarthaW@perrycommunityhospital.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Perry Community Hospital</name>
      <address>
        <city>Linden</city>
        <state>Tennessee</state>
        <zip>37096</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liane Parker, RN</last_name>
      <email>LianeP@perrycommunityhospital.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Heart Murmurs</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04483154
org study id: #20-PCHO-101
nct id: NCT04483154
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Reducing admission rates
time frame: 6 months
measure: Reduction in use of medications
time frame: 6 months
measure: Increased quality of life
time frame: 6 months
description: As measured by Rand-36
measure: Improved clinical management
time frame: 6 months
measure: Show the value of using Coala Heart Monitor in rural care - patients
time frame: 6 months
measure: Show the value of using Coala Heart Monitor in rural care - providers
time frame: 6 months
description: 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.
intervention type: Device
intervention name: Coala Heart Monitor
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
last name: David Huneycutt, MD
role: Principal Investigator
affiliation: Perry Community Hospital
last name: Valentina Lepsky-Perla, MSc
phone: 931-589-8943
email: ValentinaL@PerryCommunityHospital.org
last name: Martha Wilsdorf, RN
email: MarthaW@perrycommunityhospital.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Disease
mesh term: Heart Murmurs
sharing ipd: Undecided