<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/NCT03832192</url>
  </required_header>
  <id_info>
    <org_study_id>1R44NR017842-02</org_study_id>
    <nct_id>NCT03832192</nct_id>
  </id_info>
  <brief_title>Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study</brief_title>
  <acronym>AvatarHELP</acronym>
  <official_title>Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium, Through Psychosocial Support and Protocol-Driven Interventions Based on the Hospital Elder Life Program: a Multi-Site Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Victor Wang</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pace University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>care.coach corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Through NINR project 1R44NR017842-01 which preceded the present study, the investigators&#xD;
      enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based&#xD;
      protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration&#xD;
      with hospital-based electronic medical record (EMR) systems. In the present study, the&#xD;
      investigators seek to validate the efficacy of the new avatar platform, as measured by&#xD;
      reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to&#xD;
      gather patient and outcomes data at a scale sufficient to begin developing machine learning&#xD;
      algorithms for intelligent, automatic assignment of protocols to maximize patient engagement&#xD;
      and clinical efficacy, and for intelligent, automatic screening of delirium to assist care&#xD;
      teams in positive identification of delirium. Therefore, the present study comprises a&#xD;
      two-year randomized between-groups comparison across multiple hospitals to compare outcomes&#xD;
      with the new generation of care.coach avatars as the intervention versus usual care only as&#xD;
      the control. Each study group will be geographically distributed across participating&#xD;
      research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New&#xD;
      York, with additional hospitals to join the study over the course of two years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">January 7, 2021</completion_date>
  <primary_completion_date type="Actual">January 7, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incident Delirium Rate</measure>
    <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
    <description>For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delirium Resolution Rate</measure>
    <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
    <description>For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Function</measure>
    <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
    <description>For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Delirium Severity</measure>
    <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
    <description>For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">301</enrollment>
  <condition>Delirium</condition>
  <condition>Fall Injury</condition>
  <arm_group>
    <arm_group_label>care.coach Avatar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>care.coach Avatar (HELP-Protocolized)</intervention_name>
    <description>care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).</description>
    <arm_group_label>care.coach Avatar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aggression or combativeness with intent to harm self or others&#xD;
&#xD;
          -  severe hearing impairment and simultaneous severe vision impairment, despite assistive&#xD;
             devices&#xD;
&#xD;
          -  no comprehension of either Spanish or English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jamaica Hospital Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://care.coach</url>
    <description>care.coach human-in-the-loop avatars for psychosocial support, health coaching, and care coordination</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <results_first_submitted>May 26, 2023</results_first_submitted>
  <results_first_submitted_qc>July 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 14, 2023</results_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>care.coach corporation</investigator_affiliation>
    <investigator_full_name>Victor Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>patient satisfaction</keyword>
  <keyword>HCAHPS</keyword>
  <keyword>loneliness</keyword>
  <keyword>delirium</keyword>
  <keyword>falls</keyword>
  <keyword>HELP</keyword>
  <keyword>hospitals</keyword>
  <keyword>geriatrics</keyword>
  <keyword>elder care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03832192/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>HELP-protocolized digital avatar with daily nurse student check-in</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Usual care with daily nurse student social check-in</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participants are disenrolled upon hospital discharge.</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>HELP-protocolized digital avatar with daily nurse student check-in</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Usual care with daily nurse student social check-in</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="152"/>
            <count group_id="B2" value="149"/>
            <count group_id="B3" value="301"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="9"/>
                    <measurement group_id="B2" value="75" spread="8"/>
                    <measurement group_id="B3" value="76" spread="9"/>
                  </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="76"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="167"/>
                  </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="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="236"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short Portable Mental Status Questionnaire</title>
          <description>0 to 10 questions incorrectly answered; greater number indicates worse cognitive performance</description>
          <units>number of questions incorrectly answered</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.0" spread="1.8"/>
                    <measurement group_id="B2" value="2.6" spread="2.4"/>
                    <measurement group_id="B3" value="2.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Confusion Assessment Method</title>
          <description>Delirium screening algorithm resulting in either positive of negative presence of delirium</description>
          <units>number of positive screens</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Memorial Delirium Assessment Scale</title>
          <description>10 severity items rated 0 to 3 points for a maximum total score of 30 points, with higher scores representing more severe delirium</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.2" spread="4.6"/>
                    <measurement group_id="B2" value="14.3" spread="4.6"/>
                    <measurement group_id="B3" value="12.6" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incident Delirium Rate</title>
        <description>For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.</description>
        <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
        <population>Patients without prevalent delirium and have a final CAM screen on record</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>HELP-protocolized digital avatar with daily nurse student check-in</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care with daily nurse student social check-in</description>
          </group>
        </group_list>
        <measure>
          <title>Incident Delirium Rate</title>
          <description>For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.</description>
          <population>Patients without prevalent delirium and have a final CAM screen on record</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="87"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delirium Resolution Rate</title>
        <description>For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.</description>
        <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
        <population>Patients with prevalent delirium and a final CAM screen on record</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>HELP-protocolized digital avatar with daily nurse student check-in</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care with daily nurse student social check-in</description>
          </group>
        </group_list>
        <measure>
          <title>Delirium Resolution Rate</title>
          <description>For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.</description>
          <population>Patients with prevalent delirium and a final CAM screen on record</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="5"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cognitive Function</title>
        <description>For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.</description>
        <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
        <population>Patients with both pre- and post-test data on record</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>HELP-protocolized digital avatar with daily nurse student check-in</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care with daily nurse student social check-in</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cognitive Function</title>
          <description>For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.</description>
          <population>Patients with both pre- and post-test data on record</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="87"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="1.8"/>
                    <measurement group_id="O2" value="-0.15" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Delirium Severity</title>
        <description>For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.</description>
        <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
        <population>Patients with both pre- and post-test MDAS data</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>HELP-protocolized digital avatar with daily nurse student check-in</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care with daily nurse student social check-in</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Delirium Severity</title>
          <description>For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.</description>
          <population>Patients with both pre- and post-test MDAS data</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="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2"/>
                    <measurement group_id="O2" value="-5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From beginning to end of each participant's inpatient stay, an average of 4 days</time_frame>
      <desc>The usual definition of a &quot;serious adverse event&quot; includes an inpatient hospitalization, but all subjects are already hospitalized and therefore we are focusing on deaths unless there is a usually-defined serious or non-serious adverse event that is considered attributable to study participation.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>HELP-protocolized digital avatar with daily nurse student check-in</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Usual care with daily nurse student social check-in</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="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
              </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="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Fall &amp; patient sitter data were not recorded at the first site. Secondary sites that were to record such data were stalled by COVID. Post-tests were missing for many patients, due largely to hospital discharges occurring before researchers could conduct post-tests. Incident delirium cases were too few to draw conclusions (far below the rate suggested by literature). The team began to mitigate these data integrity problems, but were not able to rebuild a viable research assistant team post-COVID.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Principal Investigator</name_or_title>
      <organization>care.coach</organization>
      <phone>8554374569 ext 2</phone>
      <email>pi@care.coach</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/NCT03832192
org study id: 1R44NR017842-02
nct id: NCT03832192
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Through NINR project 1R44NR017842-01 which preceded the present study, the investigators
      enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based
      protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration
      with hospital-based electronic medical record (EMR) systems. In the present study, the
      investigators seek to validate the efficacy of the new avatar platform, as measured by
      reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to
      gather patient and outcomes data at a scale sufficient to begin developing machine learning
      algorithms for intelligent, automatic assignment of protocols to maximize patient engagement
      and clinical efficacy, and for intelligent, automatic screening of delirium to assist care
      teams in positive identification of delirium. Therefore, the present study comprises a
      two-year randomized between-groups comparison across multiple hospitals to compare outcomes
      with the new generation of care.coach avatars as the intervention versus usual care only as
      the control. Each study group will be geographically distributed across participating
      research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New
      York, with additional hospitals to join the study over the course of two years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Incident Delirium Rate
time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
description: For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.
measure: Delirium Resolution Rate
time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
description: For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method [CAM] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.
measure: Change in Cognitive Function
time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
description: For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.
measure: Change in Delirium Severity
time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
description: For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.
arm group label: care.coach Avatar
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: care.coach Avatar (HELP-Protocolized)
description: care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).
arm group label: care.coach Avatar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://care.coach
description: care.coach human-in-the-loop avatars for psychosocial support, health coaching, and care coordination
responsible party type: Sponsor-Investigator
investigator affiliation: care.coach corporation
investigator full name: Victor Wang
investigator title: Principal Investigator
mesh term: Delirium
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Fall & patient sitter data were not recorded at the first site. Secondary sites that were to record such data were stalled by COVID. Post-tests were missing for many patients, due largely to hospital discharges occurring before researchers could conduct post-tests. Incident delirium cases were too few to draw conclusions (far below the rate suggested by literature). The team began to mitigate these data integrity problems, but were not able to rebuild a viable research assistant team post-COVID.
point of contact: 