<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/NCT03038126</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00058634</org_study_id>
    <secondary_id>R34DK102177</secondary_id>
    <nct_id>NCT03038126</nct_id>
  </id_info>
  <brief_title>Care Coordination/Home Telehealth to Safeguard Care in CKD</brief_title>
  <acronym>CCHT in CKD</acronym>
  <official_title>Care Coordination/Telehealth to Address Patient Safety and Poor Outcomes in CKD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baltimore VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Home telehealth monitoring of veterans with chronic kidney disease, with a disease management&#xD;
      protocol and safety-specific decision support, will increase the detection of adverse safety&#xD;
      events, and in turn, reduce the need for urgent health resource utilization and associated&#xD;
      poor outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-dialysis chronic kidney disease (CKD) is associated with a high risk of harm related to&#xD;
      medical care (adverse safety events). These events may occur outside the purview of the&#xD;
      medical system, and hence, are under-recognized. Health information technology (IT) can&#xD;
      enhance the detection of such events, and coordinated care can prevent their adverse&#xD;
      consequences. Study design: 6-month randomized trial of coordinated care/home telehealth&#xD;
      (CCHT) vs usual care in CKD patients. Intervention: Veterans Administration (VA) CCHT with a&#xD;
      guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA&#xD;
      Renal Inter-disciplinary Safety clinic (RISC). Study population: Veterans with Stage III-V&#xD;
      CKD (no expected dialysis within 6 months), age ≥ 60 years old, and diabetes (n = 65 per&#xD;
      arm). Study Site: Baltimore VA Medical Center (BVAMC), VA Geriatrics Research, Education and&#xD;
      Clinical Center (GRECC), and RISC. Specific Aim 1: Compare detection of adverse safety events&#xD;
      in CKD patients assigned to CCHT vs usual care. Specific Aim 2: Compare the frequency of&#xD;
      urgent health service use and participant satisfaction with CCHT vs usual care group. Study&#xD;
      Measurements: Vital sign and clinical measurements (daily BP, weight, and finger stick&#xD;
      glucose), laboratory values, and patient- reported safety events obtained per CCHT protocol&#xD;
      vs patient-reported safety events, laboratory values, and assessment at a mid-study safety&#xD;
      clinic visit in usual care protocol. Emergency department (ED) visits, hospitalization, renal&#xD;
      progression, incidence of ESRD, and death will be measured in both groups along with patient&#xD;
      satisfaction. Outcomes: Aim 1: Counts of a diverse set of adverse safety events including&#xD;
      hypoglycemia, hypotension, volume loss (by weight change), hyperkalemia, acute kidney injury&#xD;
      (AKI), and patient-reported safety incidents. Aim 2: ED visits, hospitalization, and other&#xD;
      adverse outcomes including renal function loss, ESRD, and death. Analytic plans: Adjusted&#xD;
      rates of events tracked in Aim 1 and 2 and expressed as counts per month will be compared in&#xD;
      CCHT vs usual care group with multivariate models as indicated. Expected findings: CCHT will&#xD;
      increase the detection of adverse safety events but reduce urgent health resource utilization&#xD;
      and adverse outcomes. Public Health Relevance: Home telemonitoring of CKD patients in&#xD;
      conjunction with coordinated care and decision support can increase the detection of adverse&#xD;
      safety events that occur outside the traditional health care system and offer new&#xD;
      opportunities to reduce their associated poor outcomes on a platform that allows ready&#xD;
      dissemination across a national health network.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Events</measure>
    <time_frame>3 months, 6 months</time_frame>
    <description>number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Renal Function</measure>
    <time_frame>6 months</time_frame>
    <description>Change in GFR from baseline to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>3 months, 6 months</time_frame>
    <description>Frequency of unanticipated hospitalization events over duration of study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Safety Issues</condition>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>CCHT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CCHT</intervention_name>
    <description>Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
    <arm_group_label>CCHT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Standard clinical care</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans with Stage III-V CKD&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Expectation of dialysis or death within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Baltimore VA Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://projectreporter.nih.gov/project_info_description.cfm?aid=8856231&amp;icde=31902332&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=3&amp;csb=default&amp;cs=ASC</url>
    <description>NIH Reporter study entry</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>October 8, 2019</results_first_submitted>
  <results_first_submitted_qc>March 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2020</results_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Jeffrey Fink</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>chronic kidney disease</keyword>
  <keyword>patient safety</keyword>
  <keyword>home telehealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <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>October 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03038126/SAP_000.pdf</document_url>
    </provided_document>
    <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>October 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03038126/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CCHT</title>
          <description>Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).&#xD;
CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual care: Standard clinical care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Long Term Hospitalization</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Too Ill to Participate</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CCHT</title>
          <description>Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).&#xD;
CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual care: Standard clinical care</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="63"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="118"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.9" spread="5.4"/>
                    <measurement group_id="B2" value="70.7" spread="6.2"/>
                    <measurement group_id="B3" value="70.8" spread="5.8"/>
                  </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="61"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="37"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="63"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>eGFR</title>
          <units>ml/min/1.73m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.5" spread="12.7"/>
                    <measurement group_id="B2" value="42.4" spread="13.9"/>
                    <measurement group_id="B3" value="42.5" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety Events</title>
        <description>number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)</description>
        <time_frame>3 months, 6 months</time_frame>
        <population>number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>CCHT</title>
            <description>Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).&#xD;
CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care: Standard clinical care</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Events</title>
          <description>number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)</description>
          <population>number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.</population>
          <units>safety events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Self-Reported Safety Events (3 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Reported Safety Events (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>In-Center Safety Events (3 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>In-Center Safety Events (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Renal Function</title>
        <description>Change in GFR from baseline to 6 months</description>
        <time_frame>6 months</time_frame>
        <population>number analyzed differs from total population due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>CCHT</title>
            <description>Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).&#xD;
CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care: Standard clinical care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Renal Function</title>
          <description>Change in GFR from baseline to 6 months</description>
          <population>number analyzed differs from total population due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.</population>
          <units>ml/min/1.73m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="6.44"/>
                    <measurement group_id="O2" value="-3.19" spread="9.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization</title>
        <description>Frequency of unanticipated hospitalization events over duration of study</description>
        <time_frame>3 months, 6 months</time_frame>
        <population>number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>CCHT</title>
            <description>Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).&#xD;
CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care: Standard clinical care</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization</title>
          <description>Frequency of unanticipated hospitalization events over duration of study</description>
          <population>number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.</population>
          <units>hospitalizaztions per month</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reported at 3 month visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" lower_limit="0.07" upper_limit="0.17"/>
                    <measurement group_id="O2" value="0.14" lower_limit="0.08" upper_limit="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reported at 6 month visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" lower_limit="0.07" upper_limit="0.18"/>
                    <measurement group_id="O2" value="0.15" lower_limit="0.10" upper_limit="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CCHT</title>
          <description>Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).&#xD;
CCHT: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual care: Standard clinical care</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="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Patient-Reported Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>In-Center Hypotension</sub_title>
                <description>Systolic Blood Pressure &lt; 90 mmHg or Diastolic Blood Pressure &lt; 45 mmHg. Detected during study visit vital signs.</description>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>In-Center Orthostasis</sub_title>
                <description>Drop &gt;20 mmHg from sitting blood pressure to standing blood pressure and/or increase &gt;15 bpm from sitting pulse to standing pulse. Detected during study visit vital signs.</description>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Patient-Reported New or Worseneing Ankle Swelling</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>In-Center Hypoglycemia</sub_title>
                <description>Blood glucose &lt; 70 with or without symptoms. Detected on study visit labs.</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>In-Center Hyperglycemia</sub_title>
                <description>Blood Glucose &gt;350 mg/dL. Detected on study visit labs.</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Patient-Reported Nausea, Vomiting, and/or Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Patient-Reported Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Patient-Reported Falls</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Patient-Reported Muscle Weakness or Cramps</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Patient-Reported Hyperkalemia</sub_title>
                <description>Patient-reported high potassium blood level that required a change in medication, change in diet, and/or taking a prescription of kayexelate or polystyrene.</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="55"/>
              </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>Jeffrey C. Fink, MD MS; Principal Investigator</name_or_title>
      <organization>University of Maryland Baltimore</organization>
      <phone>410-328-4822</phone>
      <email>jfink@som.umaryland.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/NCT03038126
org study id: HP-00058634
secondary id: R34DK102177
nct id: NCT03038126
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Home telehealth monitoring of veterans with chronic kidney disease, with a disease management
      protocol and safety-specific decision support, will increase the detection of adverse safety
      events, and in turn, reduce the need for urgent health resource utilization and associated
      poor outcomes.
Pre-dialysis chronic kidney disease (CKD) is associated with a high risk of harm related to
      medical care (adverse safety events). These events may occur outside the purview of the
      medical system, and hence, are under-recognized. Health information technology (IT) can
      enhance the detection of such events, and coordinated care can prevent their adverse
      consequences. Study design: 6-month randomized trial of coordinated care/home telehealth
      (CCHT) vs usual care in CKD patients. Intervention: Veterans Administration (VA) CCHT with a
      guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA
      Renal Inter-disciplinary Safety clinic (RISC). Study population: Veterans with Stage III-V
      CKD (no expected dialysis within 6 months), age ≥ 60 years old, and diabetes (n = 65 per
      arm). Study Site: Baltimore VA Medical Center (BVAMC), VA Geriatrics Research, Education and
      Clinical Center (GRECC), and RISC. Specific Aim 1: Compare detection of adverse safety events
      in CKD patients assigned to CCHT vs usual care. Specific Aim 2: Compare the frequency of
      urgent health service use and participant satisfaction with CCHT vs usual care group. Study
      Measurements: Vital sign and clinical measurements (daily BP, weight, and finger stick
      glucose), laboratory values, and patient- reported safety events obtained per CCHT protocol
      vs patient-reported safety events, laboratory values, and assessment at a mid-study safety
      clinic visit in usual care protocol. Emergency department (ED) visits, hospitalization, renal
      progression, incidence of ESRD, and death will be measured in both groups along with patient
      satisfaction. Outcomes: Aim 1: Counts of a diverse set of adverse safety events including
      hypoglycemia, hypotension, volume loss (by weight change), hyperkalemia, acute kidney injury
      (AKI), and patient-reported safety incidents. Aim 2: ED visits, hospitalization, and other
      adverse outcomes including renal function loss, ESRD, and death. Analytic plans: Adjusted
      rates of events tracked in Aim 1 and 2 and expressed as counts per month will be compared in
      CCHT vs usual care group with multivariate models as indicated. Expected findings: CCHT will
      increase the detection of adverse safety events but reduce urgent health resource utilization
      and adverse outcomes. Public Health Relevance: Home telemonitoring of CKD patients in
      conjunction with coordinated care and decision support can increase the detection of adverse
      safety events that occur outside the traditional health care system and offer new
      opportunities to reduce their associated poor outcomes on a platform that allows ready
      dissemination across a national health network.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Safety Events
time frame: 3 months, 6 months
description: number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)
measure: Change in Renal Function
time frame: 6 months
description: Change in GFR from baseline to 6 months
measure: Hospitalization
time frame: 3 months, 6 months
description: Frequency of unanticipated hospitalization events over duration of study
arm group label: CCHT
arm group type: Active Comparator
description: Veterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
arm group label: Usual care
arm group type: Placebo Comparator
intervention type: Other
intervention name: CCHT
description: Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
arm group label: CCHT
intervention type: Other
intervention name: Usual care
description: Standard clinical care
arm group label: Usual care
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
url: http://projectreporter.nih.gov/project_info_description.cfm?aid=8856231&icde=31902332&ddparam=&ddvalue=&ddsub=&cr=3&csb=default&cs=ASC
description: NIH Reporter study entry
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Jeffrey Fink
investigator title: Professor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 