<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/NCT03247608</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #2287</org_study_id>
    <secondary_id>CHH</secondary_id>
    <nct_id>NCT03247608</nct_id>
  </id_info>
  <brief_title>ConnectedHeartHealth - Heart Failure Readmission Intervention</brief_title>
  <acronym>CHH</acronym>
  <official_title>ConnectedHeartHealth - Heart Failure Readmission Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LifeBridge Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association (AHA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>LifeBridge Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, pilot study that will evaluate the effectiveness of the AHA science&#xD;
      based CarePlans and the Ambio Health technology in improving the risk adjusted 30 day&#xD;
      readmissions rate, patient compliance, and biometrics. The study will also be used to assess&#xD;
      the feasibility of similar heart failure transition programs in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A key strategy of the Affordable Care Act is the Accountable Care Organization, designed to&#xD;
      improve the quality of care, promote population health and reduce costs by making healthcare&#xD;
      providers more accountable for health outcomes. With the increasing pressure to&#xD;
      simultaneously improve care and reduce the overall cost of care, there is increasing need for&#xD;
      better care coordination, especially for patients that are high risk for readmissions and&#xD;
      poor health outcomes, to stay connected with their healthcare provider outside of the&#xD;
      healthcare setting. Connected Heart Health is the American Heart Association's ACO&#xD;
      (Accountable Care Organization) strategy for post-acute care. This includes evidence based&#xD;
      CarePlans for heart failure, cardiac rehabilitation, and coronary artery disease. These&#xD;
      CarePlans are brought to life with technology enabled by Ambio Health, which allows patients&#xD;
      and doctors to be connected anytime and anywhere, encouraging the adoption of self-management&#xD;
      skills, healthy living, and evidence based practice, resulting in fewer cardiovascular events&#xD;
      and readmissions, and lower costs.&#xD;
&#xD;
      Ambio Health is an end-to-end remote patient monitoring system which includes a weight scale,&#xD;
      blood pressure meter and blood glucose meter with wireless transmission of biometric readings&#xD;
      through a home gateway to a web-based care management application that provides population&#xD;
      health remote patient monitoring and engagement with automated delivery of the CarePlans.&#xD;
&#xD;
      Ambio Health will be introduced as a viable method for remote monitoring of heart failure&#xD;
      patients, with an emphasis on reducing readmission rates and promoting self-management&#xD;
      skills. This program is intended to implement the AHA's Connected Heart Health CarePlan and&#xD;
      educational content for patients in conjunction with a platform designed to upload biometric&#xD;
      data and provide care coordination as directed and implemented by discharging&#xD;
      physicians/institutions. The intent is to design and execute a Pilot with Sinai Hospital of&#xD;
      Baltimore.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">October 9, 2017</completion_date>
  <primary_completion_date type="Actual">October 9, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Re-admissions rate</measure>
    <time_frame>30 Days</time_frame>
    <description>The primary endpoint will be the risk adjusted 30 day readmissions rate of the study population in comparison with the Sinai Hospital and the National Average.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance to guidelines measures</measure>
    <time_frame>30 Days</time_frame>
    <description>Additional study metrics will include compliance to evidence based guidelines using Get with the Guidelines HF measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biometrics change</measure>
    <time_frame>30 Days</time_frame>
    <description>Additional study metrics will include change in biometrics from baseline to follow up for weight, blood pressure and pro-BNP.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Ambio Health Remote Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ambio Health is an end-to-end remote patient monitoring system which includes a weight scale, blood pressure meter and blood glucose meter with wireless transmission of biometric readings through a home gateway to a web-based care management application that provides population health remote patient monitoring and engagement with automated delivery of the CarePlans.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ambio Health Remote Monitoring</intervention_name>
    <description>Participants in the Connected Heart Health study will complete a 24 week CarePlan including education, biometric monitoring, and communication with the health care team members. Each day the participant will receive an email from Ambio Health with a daily task list that includes a variety of activities. These tasks include uploading biometrics (weight and blood pressure), completing assessment on self-management skills (nutrition, physical activity, and medication management), accessing educational content (videos, web links, interactive quizzes), participation in challenges, and communicating with the care team and care givers.</description>
    <arm_group_label>Ambio Health Remote Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a diagnosis of Heart Failure as measured by the New York Heart Association (NYHA)&#xD;
             functional classification and is currently in functional class II- IV status.&#xD;
&#xD;
          -  Have been hospitalized for an episode of acute HF decompensation within the last 30&#xD;
             days.&#xD;
&#xD;
          -  Have access to the internet.&#xD;
&#xD;
          -  Are physically and mentally capable to complete the monitoring process or have a&#xD;
             caregiver capable of assisting in the use of the Ambio Health system.&#xD;
&#xD;
          -  Willing and able to sign an informed consent form to participate in this evaluation&#xD;
             for a duration of 180 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a life expectancy of less than six months.&#xD;
&#xD;
          -  Live in a nursing home other multi-member assisted living facility&#xD;
&#xD;
          -  Intend to be away from their home for more than 2 weeks (14 days) total during the&#xD;
             monitoring period.&#xD;
&#xD;
          -  Are unable to read English at a minimum 5th grade level&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Moscucci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LifeBridge Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ambio Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03247608
org study id: IRB #2287
secondary id: CHH
nct id: NCT03247608
lead sponsor: 
collaborator: 
has dmc: No
This is a single-center, pilot study that will evaluate the effectiveness of the AHA science
      based CarePlans and the Ambio Health technology in improving the risk adjusted 30 day
      readmissions rate, patient compliance, and biometrics. The study will also be used to assess
      the feasibility of similar heart failure transition programs in the future.
A key strategy of the Affordable Care Act is the Accountable Care Organization, designed to
      improve the quality of care, promote population health and reduce costs by making healthcare
      providers more accountable for health outcomes. With the increasing pressure to
      simultaneously improve care and reduce the overall cost of care, there is increasing need for
      better care coordination, especially for patients that are high risk for readmissions and
      poor health outcomes, to stay connected with their healthcare provider outside of the
      healthcare setting. Connected Heart Health is the American Heart Association's ACO
      (Accountable Care Organization) strategy for post-acute care. This includes evidence based
      CarePlans for heart failure, cardiac rehabilitation, and coronary artery disease. These
      CarePlans are brought to life with technology enabled by Ambio Health, which allows patients
      and doctors to be connected anytime and anywhere, encouraging the adoption of self-management
      skills, healthy living, and evidence based practice, resulting in fewer cardiovascular events
      and readmissions, and lower costs.

      Ambio Health is an end-to-end remote patient monitoring system which includes a weight scale,
      blood pressure meter and blood glucose meter with wireless transmission of biometric readings
      through a home gateway to a web-based care management application that provides population
      health remote patient monitoring and engagement with automated delivery of the CarePlans.

      Ambio Health will be introduced as a viable method for remote monitoring of heart failure
      patients, with an emphasis on reducing readmission rates and promoting self-management
      skills. This program is intended to implement the AHA's Connected Heart Health CarePlan and
      educational content for patients in conjunction with a platform designed to upload biometric
      data and provide care coordination as directed and implemented by discharging
      physicians/institutions. The intent is to design and execute a Pilot with Sinai Hospital of
      Baltimore.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Re-admissions rate
time frame: 30 Days
description: The primary endpoint will be the risk adjusted 30 day readmissions rate of the study population in comparison with the Sinai Hospital and the National Average.
measure: Compliance to guidelines measures
time frame: 30 Days
description: Additional study metrics will include compliance to evidence based guidelines using Get with the Guidelines HF measures.
measure: Biometrics change
time frame: 30 Days
description: Additional study metrics will include change in biometrics from baseline to follow up for weight, blood pressure and pro-BNP.
arm group label: Ambio Health Remote Monitoring
arm group type: Experimental
description: Ambio Health is an end-to-end remote patient monitoring system which includes a weight scale, blood pressure meter and blood glucose meter with wireless transmission of biometric readings through a home gateway to a web-based care management application that provides population health remote patient monitoring and engagement with automated delivery of the CarePlans.
intervention type: Behavioral
intervention name: Ambio Health Remote Monitoring
description: Participants in the Connected Heart Health study will complete a 24 week CarePlan including education, biometric monitoring, and communication with the health care team members. Each day the participant will receive an email from Ambio Health with a daily task list that includes a variety of activities. These tasks include uploading biometrics (weight and blood pressure), completing assessment on self-management skills (nutrition, physical activity, and medication management), accessing educational content (videos, web links, interactive quizzes), participation in challenges, and communicating with the care team and care givers.
arm group label: Ambio Health Remote Monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mauro Moscucci, MD
role: Principal Investigator
affiliation: LifeBridge Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Coronary Artery Disease
sharing ipd: No