<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/NCT02196922</url>
  </required_header>
  <id_info>
    <org_study_id>NCT02196922</org_study_id>
    <nct_id>NCT02196922</nct_id>
  </id_info>
  <brief_title>Telehealth Management in HF Disparity Patients</brief_title>
  <official_title>Telehealth Self-Management Program in Older Adults Living With Heart Failure in Health Disparity Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the US, racial and ethnic disparities persist, even when income, health insurance and care&#xD;
      access are addressed. For example, there is a greater prevalence of chronic heart failure&#xD;
      (CHF), higher rates of hospital use and higher death rates in blacks as compared to whites.&#xD;
      This is due to many factors including: reduced healthcare access, higher prevalence of&#xD;
      hypertension,coronary artery disease, systolic dysfunction, myocardial infarction and&#xD;
      obesity. Given the magnitude of this chronic health issue, the growth of the elderly&#xD;
      population, and increases in ethnic diversity, providers need to develop new ways of caring&#xD;
      for those with chronic conditions living in health disparity communities.&#xD;
&#xD;
      The investigators propose to implement a randomized study with health disparity&#xD;
      community-dwelling patients. A bilingual clinician will follow patients for 3 months after&#xD;
      hospitalization for CHF to test this approach for the proposed health disparity population.&#xD;
      The investigators will obtain patient/caregiver input at multiple points during the research&#xD;
      to make necessary adjustments to the intervention to ensure that disparity patients&#xD;
      accept/use the system, and are satisfied. To ensure that proposed outcomes have relevance for&#xD;
      patients, a Community Advisory Board (CAB) of stakeholders will advise the study team&#xD;
      throughout the study process. The investigators believe that studying patient use of TSM over&#xD;
      a 3 month period will: 1) identify cost-effective care approaches for patients living with&#xD;
      chronic disease; 2) involve the patient in identifying and testing approaches that work for&#xD;
      them; 3) enhance provider-patient communication; 4) teach the patient how to self-monitor and&#xD;
      explore his/her role in self-care; 5) improve patient education about treatment options and&#xD;
      6) explore how &quot;usable&quot; the patients feel the program is. If our goals are achieved, these&#xD;
      strategies will result in patient-led improvements in health, satisfaction and quality of&#xD;
      life. Knowledge gained will further understanding of the use of telehealth programs as&#xD;
      effective self-management tools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Disparities in cardiovascular disease have received particular focus, as cardiovascular&#xD;
      disease is a major contributor to differences in morbidity and mortality between blacks and&#xD;
      whites. African Americans, for example, are hospitalized for chronic heart failure (CHF) at a&#xD;
      higher rate than whites and are 30% more likely to die from CHF than white individuals.&#xD;
      Community-dwelling patients with CHF typically receive exacerbation-focused care, leading to&#xD;
      high rates of emergency department (ED) and hospital utilization. The lack of comprehensive&#xD;
      chronic disease management leads to poor patient outcomes, and increased health care costs.&#xD;
      Given the larger burden of CHF and the unfavorable disease outcomes in disparity communities,&#xD;
      a tailored and more focused management of this clinical condition is warranted.&#xD;
&#xD;
      We propose to:&#xD;
&#xD;
        1. Assess telehealth self management (TSM) usability, utilizing a mixed-methods approach,&#xD;
           focusing on patient and stakeholder input, with the goal of adapting the intervention to&#xD;
           facilitate acceptability and feasibility in a population of low-income ethnic minority&#xD;
           patients. Prior to intervention implementation, we will determine characteristics of the&#xD;
           intervention requiring adaptation to maximize usability through focus groups, with key&#xD;
           community stakeholders, patients and caregivers. We will continue the qualitative&#xD;
           usability assessment during the intervention with patients enrolled in the study to&#xD;
           identify barriers/challenges to usability, to further adapt the intervention. Finally,&#xD;
           we will use quantitative methods to assess usability. These quantitative indicators will&#xD;
           also be used to make adjustments and inform future wide-scale interventions that will be&#xD;
           conducted in this community.&#xD;
&#xD;
        2. Compare hospital utilization of low income ethnic minority patients receiving telehealth&#xD;
           technology vs. demographically matched patients receiving standard of care. A randomized&#xD;
           controlled clinical trial will be conducted to test the primary hypothesis that health&#xD;
           care utilization will be lower in the in the TSM group than the usual-care group. We&#xD;
           will specifically compare acute care and ED utilization and quality of life (Minnesota&#xD;
           QoL Questionnaire) between groups. We will adjust for potential confounders&#xD;
           (demographic, clinical, educational and functional/support variables). The target&#xD;
           population is community-dwelling CHF patients discharged home from the Nassau University&#xD;
           Medical Center.&#xD;
&#xD;
      This research will further our understanding of the use of TSM in the management of CHF for&#xD;
      low income, ethnic minority seniors. The proposed research will improve patient outcomes&#xD;
      while reducing unnecessary hospitalizations and ED burden. Chronic disease self-management&#xD;
      programs have the potential to reduce health care costs while improving patient health&#xD;
      status, particularly for medically underserved communities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1, 2014</start_date>
  <completion_date type="Actual">April 30, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>Baseline and Day 90</time_frame>
    <description>Number of hospitalizations during the 90 day observation period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emergency Department Visits</measure>
    <time_frame>Days 0-90</time_frame>
    <description>Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Baseline and Day 90</time_frame>
    <description>Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control group will receive standard of care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicare or sliding scale/uncompensated care). Standard of care patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telehealth Self Management (TSM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telehealth Self Management (TSM)</intervention_name>
    <description>Experimental: Telehealth Self Management (TSM) TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station.</description>
    <arm_group_label>Telehealth Self Management (TSM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Patients receiving standard of care experience typical chronic care management received by Medicare patients.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Heart Failure (CHF) patients about to be discharged from Nassau University&#xD;
             Medical Center (NUMC)&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  New York Heart Association (NYHA) class of 1-3&#xD;
&#xD;
          -  Primary language of Spanish or English&#xD;
&#xD;
          -  Access to a phone (land line or cell),&#xD;
&#xD;
          -  Folstein Mini Mental Status Exam (MMSE) score of 21 or higher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with heart failure NYHA class 4&#xD;
&#xD;
          -  Patients under age 18&#xD;
&#xD;
          -  Anyone with a primary language that is not English or Spanish&#xD;
&#xD;
          -  Anyone with a Folstein MMSE score under 21 (indicative of cognitive impairment)&#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>Renee Pekmezaris, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nassau University Medical Center</name>
      <address>
        <city>East Meadow</city>
        <state>New York</state>
        <zip>11554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>April 10, 2017</results_first_submitted>
  <results_first_submitted_qc>October 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2017</results_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Renee Pekmezaris</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic Heart Failure</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Self Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02196922/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02196922/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Comprehensive Outpatient Management (COM-Standard of Care)</title>
          <description>Patients in the control group will receive comprehensive outpatient management (COM)at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.&#xD;
COM: Patients receiving COM experience chronic care management received by disparity patients at a heart failure clinic.</description>
        </group>
        <group group_id="P2">
          <title>Telehealth Self Management (TSM)</title>
          <description>Telehealth Self Management (TSM): Experimental: TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Comprehensive Outpatient Management (COM)</title>
          <description>Patients in the control group will receive COM at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.&#xD;
COM: COM experience typical chronic care management received by disparity patients I a heart failure clinic.</description>
        </group>
        <group group_id="B2">
          <title>Telehealth Self Management (TSM)</title>
          <description>Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="58"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="104"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.1" spread="15.0"/>
                    <measurement group_id="B2" value="58.4" spread="15.2"/>
                    <measurement group_id="B3" value="59.9" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hospitalizations</title>
        <description>Number of hospitalizations during the 90 day observation period</description>
        <time_frame>Baseline and Day 90</time_frame>
        <population>Intention to treat population (all participants who are randomized to either COM or TSM.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Outpatient Management (COM)</title>
            <description>Patients in the COM group will receive outpatient care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.&#xD;
COM: Patients receiving COM experience typical chronic care management received by disparity patients at heart failure clinic.</description>
          </group>
          <group group_id="O2">
            <title>Telehealth Self Management (TSM)</title>
            <description>Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalizations</title>
          <description>Number of hospitalizations during the 90 day observation period</description>
          <population>Intention to treat population (all participants who are randomized to either COM or TSM.</population>
          <units>participant mean hospitalizations/90 day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".55" spread="0.9"/>
                    <measurement group_id="O2" value=".78" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Emergency Department Visits</title>
        <description>Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period</description>
        <time_frame>Days 0-90</time_frame>
        <population>Intention to Treat population (all participants to COM or TSM)</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Outpatient Management (COM)</title>
            <description>Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.&#xD;
Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic.</description>
          </group>
          <group group_id="O2">
            <title>Telehealth Self Management (TSM)</title>
            <description>Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.</description>
          </group>
        </group_list>
        <measure>
          <title>Emergency Department Visits</title>
          <description>Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period</description>
          <population>Intention to Treat population (all participants to COM or TSM)</population>
          <units>participants group mean ED visits/90 day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".69" spread=".99"/>
                    <measurement group_id="O2" value=".63" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life</title>
        <description>Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)</description>
        <time_frame>Baseline and Day 90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Outpatient Management (COM)</title>
            <description>Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.&#xD;
Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic.</description>
          </group>
          <group group_id="O2">
            <title>Telehealth Self Management (TSM)</title>
            <description>Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life</title>
          <description>Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="0" upper_limit="105"/>
                    <measurement group_id="O2" value="36.3" lower_limit="0" upper_limit="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>days 0-90</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Comprehensive Outpatient Management (COM)</title>
          <description>Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.&#xD;
Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic.</description>
        </group>
        <group group_id="E2">
          <title>Telehealth Self Management (TSM)</title>
          <description>Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Renee Pekmezaris, Ph.D., Vice President Community Health &amp; Health Services Research</name_or_title>
      <organization>Northwell Health</organization>
      <phone>516 465-3161</phone>
      <email>rpekmeza@northwell.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02196922
org study id: NCT02196922
nct id: NCT02196922
lead sponsor: 
has dmc: No
In the US, racial and ethnic disparities persist, even when income, health insurance and care
      access are addressed. For example, there is a greater prevalence of chronic heart failure
      (CHF), higher rates of hospital use and higher death rates in blacks as compared to whites.
      This is due to many factors including: reduced healthcare access, higher prevalence of
      hypertension,coronary artery disease, systolic dysfunction, myocardial infarction and
      obesity. Given the magnitude of this chronic health issue, the growth of the elderly
      population, and increases in ethnic diversity, providers need to develop new ways of caring
      for those with chronic conditions living in health disparity communities.

      The investigators propose to implement a randomized study with health disparity
      community-dwelling patients. A bilingual clinician will follow patients for 3 months after
      hospitalization for CHF to test this approach for the proposed health disparity population.
      The investigators will obtain patient/caregiver input at multiple points during the research
      to make necessary adjustments to the intervention to ensure that disparity patients
      accept/use the system, and are satisfied. To ensure that proposed outcomes have relevance for
      patients, a Community Advisory Board (CAB) of stakeholders will advise the study team
      throughout the study process. The investigators believe that studying patient use of TSM over
      a 3 month period will: 1) identify cost-effective care approaches for patients living with
      chronic disease; 2) involve the patient in identifying and testing approaches that work for
      them; 3) enhance provider-patient communication; 4) teach the patient how to self-monitor and
      explore his/her role in self-care; 5) improve patient education about treatment options and
      6) explore how "usable" the patients feel the program is. If our goals are achieved, these
      strategies will result in patient-led improvements in health, satisfaction and quality of
      life. Knowledge gained will further understanding of the use of telehealth programs as
      effective self-management tools.
Disparities in cardiovascular disease have received particular focus, as cardiovascular
      disease is a major contributor to differences in morbidity and mortality between blacks and
      whites. African Americans, for example, are hospitalized for chronic heart failure (CHF) at a
      higher rate than whites and are 30% more likely to die from CHF than white individuals.
      Community-dwelling patients with CHF typically receive exacerbation-focused care, leading to
      high rates of emergency department (ED) and hospital utilization. The lack of comprehensive
      chronic disease management leads to poor patient outcomes, and increased health care costs.
      Given the larger burden of CHF and the unfavorable disease outcomes in disparity communities,
      a tailored and more focused management of this clinical condition is warranted.

      We propose to:

        1. Assess telehealth self management (TSM) usability, utilizing a mixed-methods approach,
           focusing on patient and stakeholder input, with the goal of adapting the intervention to
           facilitate acceptability and feasibility in a population of low-income ethnic minority
           patients. Prior to intervention implementation, we will determine characteristics of the
           intervention requiring adaptation to maximize usability through focus groups, with key
           community stakeholders, patients and caregivers. We will continue the qualitative
           usability assessment during the intervention with patients enrolled in the study to
           identify barriers/challenges to usability, to further adapt the intervention. Finally,
           we will use quantitative methods to assess usability. These quantitative indicators will
           also be used to make adjustments and inform future wide-scale interventions that will be
           conducted in this community.

        2. Compare hospital utilization of low income ethnic minority patients receiving telehealth
           technology vs. demographically matched patients receiving standard of care. A randomized
           controlled clinical trial will be conducted to test the primary hypothesis that health
           care utilization will be lower in the in the TSM group than the usual-care group. We
           will specifically compare acute care and ED utilization and quality of life (Minnesota
           QoL Questionnaire) between groups. We will adjust for potential confounders
           (demographic, clinical, educational and functional/support variables). The target
           population is community-dwelling CHF patients discharged home from the Nassau University
           Medical Center.

      This research will further our understanding of the use of TSM in the management of CHF for
      low income, ethnic minority seniors. The proposed research will improve patient outcomes
      while reducing unnecessary hospitalizations and ED burden. Chronic disease self-management
      programs have the potential to reduce health care costs while improving patient health
      status, particularly for medically underserved communities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: Open label
measure: Hospitalizations
time frame: Baseline and Day 90
description: Number of hospitalizations during the 90 day observation period
measure: Emergency Department Visits
time frame: Days 0-90
description: Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period
measure: Quality of Life
time frame: Baseline and Day 90
description: Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)
arm group label: Standard of Care
arm group type: Active Comparator
description: Patients in the control group will receive standard of care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicare or sliding scale/uncompensated care). Standard of care patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.
arm group label: Telehealth Self Management (TSM)
arm group type: Experimental
description: TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station.
intervention type: Device
intervention name: Telehealth Self Management (TSM)
description: Experimental: Telehealth Self Management (TSM) TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station.
arm group label: Telehealth Self Management (TSM)
intervention type: Other
intervention name: Standard of Care
description: Patients receiving standard of care experience typical chronic care management received by Medicare patients.
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renee Pekmezaris, PhD
role: Principal Investigator
affiliation: Northwell Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Renee Pekmezaris
investigator title: principal investigator
mesh term: Heart Failure
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 