<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/NCT02213458</url>
  </required_header>
  <id_info>
    <org_study_id>1C12013003302</org_study_id>
    <secondary_id>5R01AG056715</secondary_id>
    <secondary_id>1C1CMS331346</secondary_id>
    <nct_id>NCT02213458</nct_id>
  </id_info>
  <brief_title>Care Ecosystem: Navigating Patients and Families Through Stages of Care</brief_title>
  <official_title>University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Medicare and Medicaid Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized clinical trial evaluating the benefits of a program that supports model&#xD;
      care for persons with dementia and their family caregivers. Subjects were recruited from&#xD;
      California, Nebraska and Iowa. Subjects determined to be eligible were consented and&#xD;
      randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care&#xD;
      that provided them with assistance in meeting important benchmarks in their care, for example&#xD;
      completion of legal and financial planning and strategies for minimizing caregiver burden.&#xD;
      One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes&#xD;
      include quality of life, health care utilization, caregiver burden, satisfaction with care,&#xD;
      caregiver depression, and caregiver self-efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2015</start_date>
  <completion_date type="Actual">March 8, 2018</completion_date>
  <primary_completion_date type="Actual">March 8, 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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Caregiver Burden, Baseline to One Year</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Dementia Care</measure>
    <time_frame>One year</time_frame>
    <description>A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Caregiver Depression, Baseline to One Year</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Caregiver Self-efficacy, Baseline to One Year</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1560</enrollment>
  <condition>Dementia</condition>
  <condition>Alzheimer Disease</condition>
  <condition>Dementia, Vascular</condition>
  <condition>Lewy Body Disease</condition>
  <condition>Frontotemporal Lobar Degeneration</condition>
  <condition>Memory Disorders</condition>
  <arm_group>
    <arm_group_label>Navigated Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comprehensive longitudinal continuing care program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Navigated Care</intervention_name>
    <description>Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
    <arm_group_label>Navigated Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        This study will enroll patients as well as their primary caregivers as research&#xD;
        participants.&#xD;
&#xD;
        Inclusion criteria for patient participants:&#xD;
&#xD;
          1. Patient has a diagnosis of dementia with a progressive course&#xD;
&#xD;
          2. Patient has a primary caregiver (identified as having primary responsibility for&#xD;
             patient) that is eligible for and agrees to join the study&#xD;
&#xD;
          3. Patient is covered by Medicare or Medi-caid or is Medi-pending&#xD;
&#xD;
          4. Patient is expected to live at least 3 months based on assessment by the referring&#xD;
             provider, the patient's primary care provider, or medical record review&#xD;
&#xD;
          5. Patient speaks either English, Cantonese, Mandarin, or Spanish&#xD;
&#xD;
          6. Patient lives in California or Nebraska or Iowa&#xD;
&#xD;
          7. Patient is age 45 or older&#xD;
&#xD;
        Inclusion criteria for caregiver participants:&#xD;
&#xD;
          1. Caregiver has primary responsibility for dementia patient that is eligible for and&#xD;
             agrees to join the study&#xD;
&#xD;
          2. Caregiver speaks either English, Cantonese, Mandarin, or Spanish&#xD;
&#xD;
          3. Caregiver is a legal adult&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient resides in a nursing home or skilled nursing facility at time of enrollment&#xD;
&#xD;
          2. Participant is enrolled in a similar clinical trial that precludes their participation&#xD;
             in our trial&#xD;
&#xD;
          3. Patient is pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine L Possin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>July 20, 2021</results_first_submitted>
  <results_first_submitted_qc>August 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2021</results_first_posted>
  <last_update_submitted>August 13, 2021</last_update_submitted>
  <last_update_submitted_qc>August 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pragmatic Clinical Trial</keyword>
  <keyword>Family Caregivers</keyword>
  <keyword>Patient Care Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Memory Disorders</mesh_term>
    <mesh_term>Lewy Body Disease</mesh_term>
    <mesh_term>Dementia, Vascular</mesh_term>
    <mesh_term>Frontotemporal Lobar Degeneration</mesh_term>
  </condition_browse>
  <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>August 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02213458/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>August 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02213458/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Navigated Care</title>
          <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
        </group>
        <group group_id="P2">
          <title>Survey of Care</title>
          <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated 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="1024"/>
                <participants group_id="P2" count="536"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="970"/>
                <participants group_id="P2" count="526"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>No longer meets criteria: caregiver deceased</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets criteria: caregiver no longer caregiving</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets criteria: caregiver too sick to participate</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets criteria: patient moved out of state</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused re-consent</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <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="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Navigated Care</title>
          <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
        </group>
        <group group_id="B2">
          <title>Survey of Care</title>
          <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated 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="1024"/>
            <count group_id="B2" value="536"/>
            <count group_id="B3" value="1560"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="241"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="398"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="783"/>
                    <measurement group_id="B2" value="379"/>
                    <measurement group_id="B3" value="1162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="78.1" spread="8.66"/>
                    <measurement group_id="B2" value="78.1" spread="12.0"/>
                    <measurement group_id="B3" value="78.1" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="656"/>
                    <measurement group_id="B2" value="336"/>
                    <measurement group_id="B3" value="992"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="226"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="107"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="911"/>
                    <measurement group_id="B2" value="477"/>
                    <measurement group_id="B3" value="1388"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="825"/>
                    <measurement group_id="B2" value="447"/>
                    <measurement group_id="B3" value="1272"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="109"/>
                  </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="1024"/>
                    <measurement group_id="B2" value="536"/>
                    <measurement group_id="B3" value="1560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year</title>
        <description>An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life</description>
        <time_frame>Baseline to one year</time_frame>
        <population>The subset of caregivers with completed QDRS and Quality of Life questionnaires at baseline and 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Navigated Care</title>
            <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
          </group>
          <group group_id="O2">
            <title>Survey of Care</title>
            <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year</title>
          <description>An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life</description>
          <population>The subset of caregivers with completed QDRS and Quality of Life questionnaires at baseline and 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="504"/>
                <count group_id="O2" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.43" spread="5.64"/>
                    <measurement group_id="O2" value="-1.12" spread="5.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed effects model</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Controlling for dementia severity (QDRS)</method_desc>
            <param_type>Slope</param_type>
            <param_value>.539</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.259</ci_lower_limit>
            <ci_upper_limit>1.337</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year</title>
        <description>Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.</description>
        <time_frame>Baseline to one year</time_frame>
        <population>Subset of patients with complete data on QDRS and emergency department visits at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Navigated Care</title>
            <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
          </group>
          <group group_id="O2">
            <title>Survey of Care</title>
            <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year</title>
          <description>Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.</description>
          <population>Subset of patients with complete data on QDRS and emergency department visits at baseline</population>
          <units>number of encounters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".0483" spread=".703"/>
                    <measurement group_id="O2" value=".175" spread=".840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.05</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed model controlling for dementia severity (QDRS)</method_desc>
            <param_type>Slope</param_type>
            <param_value>-.138</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.295</ci_lower_limit>
            <ci_upper_limit>-.020</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Caregiver Burden, Baseline to One Year</title>
        <description>Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.</description>
        <time_frame>Baseline to one year</time_frame>
        <population>Subset of patients with complete data on QDRS and Zarit burden at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Navigated Care</title>
            <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
          </group>
          <group group_id="O2">
            <title>Survey of Care</title>
            <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Caregiver Burden, Baseline to One Year</title>
          <description>Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.</description>
          <population>Subset of patients with complete data on QDRS and Zarit burden at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="262"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.682" spread="8.144"/>
                    <measurement group_id="O2" value="-1.482" spread="8.641"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed model controlling for dementia severity (QDRS)</method_desc>
            <param_type>Slope</param_type>
            <param_value>-1.902</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.885</ci_lower_limit>
            <ci_upper_limit>-0.080</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Dementia Care</title>
        <description>A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.</description>
        <time_frame>One year</time_frame>
        <population>Navigated Care caregivers with completed caregiver satisfaction questionnaire at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Navigated Care</title>
            <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Dementia Care</title>
          <description>A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.</description>
          <population>Navigated Care caregivers with completed caregiver satisfaction questionnaire at 12 months</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="325"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very satisfied with Care Ecosystem services</title>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Satisfied with Care Ecosystem services</title>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral toward Care Ecosystem services</title>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsatisfied with Care Ecosystem services</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very unsatisfied with Care Ecosystem services</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Caregiver Depression, Baseline to One Year</title>
        <description>Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.</description>
        <time_frame>Baseline to one year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Navigated Care</title>
            <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
          </group>
          <group group_id="O2">
            <title>Survey of Care</title>
            <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Caregiver Depression, Baseline to One Year</title>
          <description>Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="262"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.831" spread="4.312"/>
                    <measurement group_id="O2" value="-0.238" spread="4.053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Slope</param_type>
            <param_value>-1.143</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.154</ci_lower_limit>
            <ci_upper_limit>-0.132</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Caregiver Self-efficacy, Baseline to One Year</title>
        <description>A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.</description>
        <time_frame>Baseline to one year</time_frame>
        <population>Dyads with baseline data on dementia severity (QDRS) and self-efficacy</population>
        <group_list>
          <group group_id="O1">
            <title>Navigated Care</title>
            <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
          </group>
          <group group_id="O2">
            <title>Survey of Care</title>
            <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Caregiver Self-efficacy, Baseline to One Year</title>
          <description>A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.</description>
          <population>Dyads with baseline data on dementia severity (QDRS) and self-efficacy</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="262"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.356" spread="3.038"/>
                    <measurement group_id="O2" value="1.043" spread="2.647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.11</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Controlling for dementia severity (QDRS)</method_desc>
            <param_type>Slope</param_type>
            <param_value>.635</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.135</ci_lower_limit>
            <ci_upper_limit>1.405</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Navigated Care</title>
          <description>Comprehensive longitudinal continuing care program&#xD;
Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a &quot;dashboard&quot; functions as a patient care management system used by Care Team Navigators (CTNs).</description>
        </group>
        <group group_id="E2">
          <title>Survey of Care</title>
          <description>Control group that will undergo the same regular assessments as patients enrolled in Navigated Care</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="74" subjects_at_risk="1024"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="536"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="269" subjects_at_risk="1024"/>
                <counts group_id="E2" subjects_affected="143" subjects_at_risk="536"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Overnight hospitalization</sub_title>
                <counts group_id="E1" events="433" subjects_affected="218" subjects_at_risk="1024"/>
                <counts group_id="E2" events="194" subjects_affected="116" subjects_at_risk="536"/>
              </event>
              <event>
                <sub_title>Severe fall</sub_title>
                <description>Falls resulting in major injury (broken bone, major bleeding, or loss of consciousness)</description>
                <counts group_id="E1" events="57" subjects_affected="51" subjects_at_risk="1024"/>
                <counts group_id="E2" events="34" subjects_affected="32" subjects_at_risk="536"/>
              </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="1024"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="536"/>
              </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>
    <limitations_and_caveats>The economic outcomes are not reported beyond 12-month follow-up and were based only on survey data. Our sample likely differs in important ways from samples from similar programs that do not have a randomized control condition. During our recruitment and consent process, the only potential benefit communicated to prospective enrollees was that participation might inform and advance the quality of care provided to patients with dementia (PWDs) and their caregivers in the future.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Katherine Possin</name_or_title>
      <organization>University of California, San Francisco</organization>
      <phone>(415) 476-1889</phone>
      <email>katherine.possin@ucsf.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/NCT02213458
org study id: 1C12013003302
secondary id: 5R01AG056715
secondary id: 1C1CMS331346
nct id: NCT02213458
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This is a randomized clinical trial evaluating the benefits of a program that supports model
      care for persons with dementia and their family caregivers. Subjects were recruited from
      California, Nebraska and Iowa. Subjects determined to be eligible were consented and
      randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care
      that provided them with assistance in meeting important benchmarks in their care, for example
      completion of legal and financial planning and strategies for minimizing caregiver burden.
      One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes
      include quality of life, health care utilization, caregiver burden, satisfaction with care,
      caregiver depression, and caregiver self-efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year
time frame: Baseline to one year
description: An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life
measure: Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year
time frame: Baseline to one year
description: Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.
measure: Change in Caregiver Burden, Baseline to One Year
time frame: Baseline to one year
description: Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.
measure: Satisfaction With Dementia Care
time frame: One year
description: A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.
measure: Change in Caregiver Depression, Baseline to One Year
time frame: Baseline to one year
description: Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.
measure: Change in Caregiver Self-efficacy, Baseline to One Year
time frame: Baseline to one year
description: A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.
arm group label: Navigated Care
arm group type: Experimental
description: Comprehensive longitudinal continuing care program
arm group label: Survey of Care
arm group type: No Intervention
description: Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
intervention type: Behavioral
intervention name: Navigated Care
description: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).
arm group label: Navigated Care
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine L Possin, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Memory Disorders
mesh term: Lewy Body Disease
mesh term: Dementia, Vascular
mesh term: Frontotemporal Lobar Degeneration
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The economic outcomes are not reported beyond 12-month follow-up and were based only on survey data. Our sample likely differs in important ways from samples from similar programs that do not have a randomized control condition. During our recruitment and consent process, the only potential benefit communicated to prospective enrollees was that participation might inform and advance the quality of care provided to patients with dementia (PWDs) and their caregivers in the future.
point of contact: 