<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/NCT04460742</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004519</org_study_id>
    <secondary_id>5K23AG058757-02</secondary_id>
    <secondary_id>3 K 23 AG058757-02S1</secondary_id>
    <nct_id>NCT04460742</nct_id>
  </id_info>
  <brief_title>CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition</brief_title>
  <official_title>CAPABLE Transitions: A Randomized, Unblinded, 60-Subject Clinical Trial of an Occupational Therapy-Led In-Home Intervention to Help Older Adults Transition to Their Homes Following Hospital or Post-Acute Care Facility Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</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>
      This clinical study is designed to test the feasibility of a new intervention, CAPABLE&#xD;
      Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better&#xD;
      Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins&#xD;
      University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy&#xD;
      (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home&#xD;
      intervention over 3-4 months. This intervention is designed to help with the transition of&#xD;
      care from a hospital or post-acute care facility discharge as well as to optimize functioning&#xD;
      and home safety. This clinical study plans to recruit a total of 60 older adults with and&#xD;
      without dementia admitted to a home health agency following discharge from a hospital or&#xD;
      post-acute care facility. Given that this is a feasibility study, it is not designed or&#xD;
      powered to test hypotheses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is a randomized, care-as-usual (CAU)-comparator, unblinded clinical trial of&#xD;
      an occupational therapy (OT)-led in-home intervention designed to help older adults&#xD;
      successfully return to and remain in their homes following discharge from a hospital or&#xD;
      post-acute care facility (e.g., skilled nursing or inpatient rehabilitation facilities). This&#xD;
      intervention is called CAPABLE Transitions. In total, 60 adults (36 in the intervention arm,&#xD;
      24 in the CAU arm) aged 65 years and older recently discharged from a hospital or post-acute&#xD;
      care facility and admitted to a Medicare-certified home health agency (CHHA) with and without&#xD;
      dementia will be recruited. This pilot study's main outcomes relate to the feasibility of the&#xD;
      study. These outcomes include study recruitment and retention, fidelity to and perceived&#xD;
      benefit of the intervention, and data completeness with regard to clinical outcomes (e.g.,&#xD;
      home time, quality of life, and health care utilization).&#xD;
&#xD;
      This study will recruit English-speaking adults aged 65 years and older who live in the&#xD;
      Rochester region and are admitted to a CHHA following a hospital or post-acute care facility&#xD;
      stay. There are two treatment groups. The intervention group will receive CAPABLE Transitions&#xD;
      as well as CHHA CAU services. The CAU group will receive CHHA CAU services, which can include&#xD;
      nursing, health aide, medical social work, and occupational, physical, and speech therapy&#xD;
      services. CHHA clinicians will determine the types and duration of CHHA services that the&#xD;
      study participants receive; these services will be completely independent from the research&#xD;
      study.&#xD;
&#xD;
      Assessment interviews will be conducted at baseline as well as at three and six month&#xD;
      follow-up. Interviews will assess sociodemographics, health and functioning, mental health&#xD;
      and cognitive functioning, home environment, medical services use, and intervention feedback.&#xD;
      Information also will be extracted on medical conditions, medications, communication with&#xD;
      providers, and services utilization from participants' medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2021</start_date>
  <completion_date type="Actual">May 19, 2023</completion_date>
  <primary_completion_date type="Actual">May 19, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Screened as Eligible</measure>
    <time_frame>For each potential participant, this outcome is determined prior to possible study enrollment.</time_frame>
    <description>The study will monitor how many older adults are screened and satisfy the eligibility criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Screened Participants That Enroll</measure>
    <time_frame>This outcome is determined at the time of study enrollment.</time_frame>
    <description>The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Enrolled Participants That Are Retained</measure>
    <time_frame>6 months</time_frame>
    <description>The study will monitor the percentage of participants that complete the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Perceive a Benefit From the Intervention</measure>
    <time_frame>3 months</time_frame>
    <description>Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Perceive a Benefit From the Intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Critical Tasks Completed</measure>
    <time_frame>Throughout Study Intervention, an average of 5 months</time_frame>
    <description>The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as &quot;yes&quot; or &quot;no&quot; and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data Completeness on Clinical Outcomes</measure>
    <time_frame>3 months</time_frame>
    <description>The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data Completeness on Clinical Outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Home Time in Days (From the Baseline to 3 Month Period)</measure>
    <time_frame>Baseline to Month 3 (3 months)</time_frame>
    <description>Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from baseline to 3 months of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home Time in Days (From the 3 to 6 Month Period)</measure>
    <time_frame>Month 3 to Month 6 (3 months)</time_frame>
    <description>Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from 3 to 6 months of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)</measure>
    <time_frame>3 months</time_frame>
    <description>The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up (positive scores indicate improvement from baseline).&#xD;
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.&#xD;
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)</measure>
    <time_frame>6 months</time_frame>
    <description>The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up (positive scores indicate improvement from baseline).&#xD;
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.&#xD;
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Services Use, Percentage</measure>
    <time_frame>Baseline to Month 3 (3 months)</time_frame>
    <description>The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Services Use, Percentage</measure>
    <time_frame>Month 3 to Month 6 (3 months)</time_frame>
    <description>The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Services Use, Mean</measure>
    <time_frame>Baseline to Month 3 (3 months)</time_frame>
    <description>The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Services Use, Mean</measure>
    <time_frame>Month 3 to Month 6 (3 months)</time_frame>
    <description>The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Care Transitions</condition>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>CAPABLE Transitions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care As Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CAPABLE Transitions</intervention_name>
    <description>The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.</description>
    <arm_group_label>CAPABLE Transitions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Health Agency Care</intervention_name>
    <description>Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
    <arm_group_label>CAPABLE Transitions</arm_group_label>
    <arm_group_label>Care As Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admitted to Medicare-certified home health agency following discharge from a hospital,&#xD;
             inpatient rehabilitation facility, or skilled nursing facility&#xD;
&#xD;
          -  live in Rochester, NY region&#xD;
&#xD;
          -  aged 65 years or older&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  plan to move within one year&#xD;
&#xD;
          -  has a terminal diagnosis (e.g., &lt; 1-year life expectancy, in hospice)&#xD;
&#xD;
          -  receiving active cancer treatment (active treatment includes surgery or a course of&#xD;
             radiation or chemotherapy; it does not include long-term maintenance treatment such as&#xD;
             daily hormonal treatment of prostate cancer)&#xD;
&#xD;
          -  inability or unwillingness of individual or legal guardian/representative to give&#xD;
             written informed consent or assent&#xD;
&#xD;
          -  has been discharged from a hospital or post-acute care facility for more than 28 days&#xD;
&#xD;
          -  are COVID-19 positive, have suspected COVID-19 infection, or resides with a person who&#xD;
             is COVID-19 positive or has suspected COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Simning, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <results_first_submitted>May 22, 2023</results_first_submitted>
  <results_first_submitted_qc>July 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 1, 2023</results_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Adam Simning</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Post-acute care</keyword>
  <keyword>Home health agency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared upon request as part of a academic collaboration</ipd_description>
  </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>November 28, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04460742/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 28, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04460742/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CAPABLE Transitions</title>
          <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
        </group>
        <group group_id="P2">
          <title>Care As Usual</title>
          <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CAPABLE Transitions</title>
          <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
        </group>
        <group group_id="B2">
          <title>Care As Usual</title>
          <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</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="16"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="31"/>
          </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="77" spread="6.66"/>
                    <measurement group_id="B2" value="71.8" spread="6.33"/>
                    <measurement group_id="B3" value="74.5" spread="6.92"/>
                  </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="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Screened as Eligible</title>
        <description>The study will monitor how many older adults are screened and satisfy the eligibility criteria.</description>
        <time_frame>For each potential participant, this outcome is determined prior to possible study enrollment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overall Study Screening and Recruitment</title>
            <description>This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Screened as Eligible</title>
          <description>The study will monitor how many older adults are screened and satisfy the eligibility criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Screened Participants That Enroll</title>
        <description>The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.</description>
        <time_frame>This outcome is determined at the time of study enrollment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overall Study Screening and Recruitment</title>
            <description>This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Screened Participants That Enroll</title>
          <description>The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Enrolled Participants That Are Retained</title>
        <description>The study will monitor the percentage of participants that complete the study.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Enrolled Participants That Are Retained</title>
          <description>The study will monitor the percentage of participants that complete the study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Perceive a Benefit From the Intervention</title>
        <description>Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Perceive a Benefit From the Intervention</title>
          <description>Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Perceive a Benefit From the Intervention</title>
        <description>Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Perceive a Benefit From the Intervention</title>
          <description>Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Critical Tasks Completed</title>
        <description>The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as &quot;yes&quot; or &quot;no&quot; and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.</description>
        <time_frame>Throughout Study Intervention, an average of 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Critical Tasks Completed</title>
          <description>The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as &quot;yes&quot; or &quot;no&quot; and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.</description>
          <units>Proportion of Critical Tasks Completed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Critical Tasks</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Critical Tasks</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Data Completeness on Clinical Outcomes</title>
        <description>The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Data Completeness on Clinical Outcomes</title>
          <description>The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Data Completeness on Clinical Outcomes</title>
        <description>The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Data Completeness on Clinical Outcomes</title>
          <description>The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Home Time in Days (From the Baseline to 3 Month Period)</title>
        <description>Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from baseline to 3 months of follow-up.</description>
        <time_frame>Baseline to Month 3 (3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Home Time in Days (From the Baseline to 3 Month Period)</title>
          <description>Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from baseline to 3 months of follow-up.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.94" spread="7.25"/>
                    <measurement group_id="O2" value="88.67" spread="3.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Home Time in Days (From the 3 to 6 Month Period)</title>
        <description>Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from 3 to 6 months of follow-up.</description>
        <time_frame>Month 3 to Month 6 (3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Home Time in Days (From the 3 to 6 Month Period)</title>
          <description>Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from 3 to 6 months of follow-up.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.38" spread="2.00"/>
                    <measurement group_id="O2" value="89.86" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)</title>
        <description>The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up (positive scores indicate improvement from baseline).&#xD;
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.&#xD;
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)</title>
          <description>The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up (positive scores indicate improvement from baseline).&#xD;
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.&#xD;
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.</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="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobility Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="1.33"/>
                    <measurement group_id="O2" value="1.07" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Care Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="0.74"/>
                    <measurement group_id="O2" value="0.50" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="1.39"/>
                    <measurement group_id="O2" value="0.79" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.96"/>
                    <measurement group_id="O2" value="0.36" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.64"/>
                    <measurement group_id="O2" value="0.14" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Rated Health Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.27" spread="28.29"/>
                    <measurement group_id="O2" value="1.43" spread="15.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)</title>
        <description>The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up (positive scores indicate improvement from baseline).&#xD;
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.&#xD;
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)</title>
          <description>The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up (positive scores indicate improvement from baseline).&#xD;
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.&#xD;
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.</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="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobility Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="1.09"/>
                    <measurement group_id="O2" value="0.71" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Care Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="0.94"/>
                    <measurement group_id="O2" value="0.36" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="1.19"/>
                    <measurement group_id="O2" value="0.93" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="1.07"/>
                    <measurement group_id="O2" value="0.50" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="1.01"/>
                    <measurement group_id="O2" value="-0.29" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Rated Health Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.07" spread="26.83"/>
                    <measurement group_id="O2" value="10.5" spread="12.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Services Use, Percentage</title>
        <description>The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.</description>
        <time_frame>Baseline to Month 3 (3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Services Use, Percentage</title>
          <description>The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ED Visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skilled Nursing Facility Admission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Services Use, Percentage</title>
        <description>The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.</description>
        <time_frame>Month 3 to Month 6 (3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Services Use, Percentage</title>
          <description>The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ED Visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skilled Nursing Facility Admission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Services Use, Mean</title>
        <description>The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.</description>
        <time_frame>Baseline to Month 3 (3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Services Use, Mean</title>
          <description>The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.</description>
          <units>events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ED Visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.25"/>
                    <measurement group_id="O2" value="0.07" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.34"/>
                    <measurement group_id="O2" value="0.27" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skilled Nursing Facility Admission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Services Use, Mean</title>
        <description>The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.</description>
        <time_frame>Month 3 to Month 6 (3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CAPABLE Transitions</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
          <group group_id="O2">
            <title>Care As Usual</title>
            <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Services Use, Mean</title>
          <description>The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.</description>
          <units>events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ED Visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.40"/>
                    <measurement group_id="O2" value="0.14" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.34"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skilled Nursing Facility Admission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From study recruitment to termination of data collection, an average of 6 months.</time_frame>
      <desc>At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.</desc>
      <group_list>
        <group group_id="E1">
          <title>CAPABLE Transitions</title>
          <description>Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.&#xD;
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (&lt;6 visits), registered nurse (&lt;5 visits), and handyman (&lt;2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</description>
        </group>
        <group group_id="E2">
          <title>Care As Usual</title>
          <description>Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.&#xD;
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.</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="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain and discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Joint infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle cramping or swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Fall with injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Substance intoxication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COPD Exacerbation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 Exposure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Minor back fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Adam Simning</name_or_title>
      <organization>University of Rochester</organization>
      <phone>585-474-9534</phone>
      <email>adam_simning@urmc.rochester.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/NCT04460742
org study id: STUDY00004519
secondary id: 5K23AG058757-02
secondary id: 3 K 23 AG058757-02S1
nct id: NCT04460742
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical study is designed to test the feasibility of a new intervention, CAPABLE
      Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better
      Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins
      University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy
      (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home
      intervention over 3-4 months. This intervention is designed to help with the transition of
      care from a hospital or post-acute care facility discharge as well as to optimize functioning
      and home safety. This clinical study plans to recruit a total of 60 older adults with and
      without dementia admitted to a home health agency following discharge from a hospital or
      post-acute care facility. Given that this is a feasibility study, it is not designed or
      powered to test hypotheses.
This pilot study is a randomized, care-as-usual (CAU)-comparator, unblinded clinical trial of
      an occupational therapy (OT)-led in-home intervention designed to help older adults
      successfully return to and remain in their homes following discharge from a hospital or
      post-acute care facility (e.g., skilled nursing or inpatient rehabilitation facilities). This
      intervention is called CAPABLE Transitions. In total, 60 adults (36 in the intervention arm,
      24 in the CAU arm) aged 65 years and older recently discharged from a hospital or post-acute
      care facility and admitted to a Medicare-certified home health agency (CHHA) with and without
      dementia will be recruited. This pilot study's main outcomes relate to the feasibility of the
      study. These outcomes include study recruitment and retention, fidelity to and perceived
      benefit of the intervention, and data completeness with regard to clinical outcomes (e.g.,
      home time, quality of life, and health care utilization).

      This study will recruit English-speaking adults aged 65 years and older who live in the
      Rochester region and are admitted to a CHHA following a hospital or post-acute care facility
      stay. There are two treatment groups. The intervention group will receive CAPABLE Transitions
      as well as CHHA CAU services. The CAU group will receive CHHA CAU services, which can include
      nursing, health aide, medical social work, and occupational, physical, and speech therapy
      services. CHHA clinicians will determine the types and duration of CHHA services that the
      study participants receive; these services will be completely independent from the research
      study.

      Assessment interviews will be conducted at baseline as well as at three and six month
      follow-up. Interviews will assess sociodemographics, health and functioning, mental health
      and cognitive functioning, home environment, medical services use, and intervention feedback.
      Information also will be extracted on medical conditions, medications, communication with
      providers, and services utilization from participants' medical records.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of Participants Screened as Eligible
time frame: For each potential participant, this outcome is determined prior to possible study enrollment.
description: The study will monitor how many older adults are screened and satisfy the eligibility criteria.
measure: Percentage of Screened Participants That Enroll
time frame: This outcome is determined at the time of study enrollment.
description: The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.
measure: Percentage of Enrolled Participants That Are Retained
time frame: 6 months
description: The study will monitor the percentage of participants that complete the study.
measure: Percentage of Participants Who Perceive a Benefit From the Intervention
time frame: 3 months
description: Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
measure: Percentage of Participants Who Perceive a Benefit From the Intervention
time frame: 6 months
description: Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
measure: Proportion of Critical Tasks Completed
time frame: Throughout Study Intervention, an average of 5 months
description: The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as "yes" or "no" and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.
measure: Data Completeness on Clinical Outcomes
time frame: 3 months
description: The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.
measure: Data Completeness on Clinical Outcomes
time frame: 6 months
description: The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.
measure: Home Time in Days (From the Baseline to 3 Month Period)
time frame: Baseline to Month 3 (3 months)
description: Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from baseline to 3 months of follow-up.
measure: Home Time in Days (From the 3 to 6 Month Period)
time frame: Month 3 to Month 6 (3 months)
description: Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from 3 to 6 months of follow-up.
measure: Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
time frame: 3 months
description: The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up (positive scores indicate improvement from baseline).
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.
measure: Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
time frame: 6 months
description: The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up (positive scores indicate improvement from baseline).
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.
measure: Health Services Use, Percentage
time frame: Baseline to Month 3 (3 months)
description: The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.
measure: Health Services Use, Percentage
time frame: Month 3 to Month 6 (3 months)
description: The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.
measure: Health Services Use, Mean
time frame: Baseline to Month 3 (3 months)
description: The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.
measure: Health Services Use, Mean
time frame: Month 3 to Month 6 (3 months)
description: The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.
arm group label: CAPABLE Transitions
arm group type: Experimental
description: Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.
arm group label: Care As Usual
arm group type: Active Comparator
description: Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
intervention type: Behavioral
intervention name: CAPABLE Transitions
description: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (<6 visits), registered nurse (<5 visits), and handyman (<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
arm group label: CAPABLE Transitions
intervention type: Behavioral
intervention name: Home Health Agency Care
description: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
arm group label: CAPABLE Transitions
arm group label: Care As Usual
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Adam Simning, MD, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Adam Simning
investigator title: Assistant Professor
mesh term: Dementia
sharing ipd: Yes
ipd description: IPD will be shared upon request as part of a academic collaboration
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 