xml: <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/NCT05985044</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00244792</org_study_id>
      <secondary_id>P30NR018093</secondary_id>
      <nct_id>NCT05985044</nct_id>
    </id_info>
    <brief_title>Living With Multimorbidity: CO-ORDINATE Program</brief_title>
    <official_title>Living With Multimorbidity: Symptom Management Across the Illness Trajectory</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Nursing Research (NINR)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Multimorbidity is common and is the coexistence of two or more chronic conditions in the same&#xD;
        individual. People with multimorbidity suffer from a high symptom burden, directly affecting&#xD;
        quality of life (QOL). Hospitalization can be a window of opportunity to initiate&#xD;
        interventions to promote recovery and resilience and enhance QOL. However, interventions&#xD;
        targeting the symptom trajectory and burden of patients with multimorbidity are lacking.&#xD;
        Thus, the investigators envisage a nurse-led pre-discharge intervention augmented by&#xD;
        telephone support, focusing on care coordination and symptom management. This approach is&#xD;
        anticipated to help reduce symptom burden and improve QOL.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim 1: Describe the symptom trajectory and burden from the perspectives of patients, family&#xD;
        caregivers, and health professionals and collectively develop a symptom management toolkit;&#xD;
        and&#xD;
  &#xD;
        Aim 2: Refine and pilot test the nurse-driven symptom management toolkit/intervention to&#xD;
        decrease the symptom burden and increase the QOL of critically ill adults with&#xD;
        multimorbidity.&#xD;
  &#xD;
        Interventional study (Aim 2):&#xD;
  &#xD;
        The study aims to test the feasibility of the Care cOORDInatioN and sympTom managEment&#xD;
        (COORDINATE) intervention developed from Aim 1 using an experienced-based co-design&#xD;
        methodology. A single-arm feasibility study will be implemented with assumptions on the&#xD;
        effectiveness of the COORDINATE intervention on outcomes such as symptom burden and quality&#xD;
        of life will be evaluated.&#xD;
  &#xD;
        Sample and Setting:&#xD;
  &#xD;
        Individuals aged 55 years and older, living with two or more chronic health conditions, and&#xD;
        willing to provide informed consent will be included in the study. The exclusion criteria&#xD;
        include if participants cannot speak English or have a documented cognitive impairment that&#xD;
        would prevent participation. Patients will be approached in the Intermediate Care Unit (IMCU)&#xD;
        of an academic teaching hospital while the participants are in-patient before discharge.&#xD;
  &#xD;
        Intervention Components and Timing:&#xD;
  &#xD;
        The intervention consists of four components- i) needs assessment; ii) question prompt list;&#xD;
        iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start&#xD;
        with the enrolment of a patient living with multimorbidity. The intervention consists of one&#xD;
        in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48&#xD;
        hours, 1 week, 4 weeks, and 6 weeks post-discharge).&#xD;
  &#xD;
        Primary Outcomes&#xD;
  &#xD;
          1. Symptom Burden&#xD;
  &#xD;
          2. Quality of Life&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 22, 2022</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score</measure>
      <time_frame>Baseline, 6 weeks, and after completion of intervention up to 3 months</time_frame>
      <description>The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Quality of Life assessed by Short Form Survey (SF-36) score</measure>
      <time_frame>Baseline, 6 weeks, and after completion of intervention up to 3 months</time_frame>
      <description>Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Health-care utilization</measure>
      <time_frame>Baseline, 6 weeks, and after completion of intervention up to 3 months</time_frame>
      <description>Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of hospitalizations, emergency visits and critical care admissions. Higher the numbers higher the healthcare utilization.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Multimorbidity</condition>
    <condition>Quality of Life</condition>
    <condition>Symptom Management</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention</intervention_name>
      <description>The intervention consists of the following four components: i) needs assessment; ii) question prompt list; iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start with the enrolment of a patient living with multimorbidity. The intervention consists of one in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge).</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English speakers who are planned for discharge from Johns Hopkins Hospital (JHH) IMCU&#xD;
  &#xD;
            -  Who meet the criteria for being admitted to IMCU and planned discharge with&#xD;
               multimorbidity as defined by two or more chronic conditions.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Who can not provide informed consent or have documented cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Binu Koirala, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins School of Nursing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Binu Koirala, PhD</last_name>
      <phone>410-614-4718</phone>
      <email>bkoiral1@jhu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Johns Hopkins School of Nursing</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21205</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Binu Koirala, PhD</last_name>
        <phone>410-614-4718</phone>
        <email>bkoiral1@jhu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985044
  org study id: IRB00244792
  secondary id: P30NR018093
  nct id: NCT05985044
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Multimorbidity is common and is the coexistence of two or more chronic conditions in the same
        individual. People with multimorbidity suffer from a high symptom burden, directly affecting
        quality of life (QOL). Hospitalization can be a window of opportunity to initiate
        interventions to promote recovery and resilience and enhance QOL. However, interventions
        targeting the symptom trajectory and burden of patients with multimorbidity are lacking.
        Thus, the investigators envisage a nurse-led pre-discharge intervention augmented by
        telephone support, focusing on care coordination and symptom management. This approach is
        anticipated to help reduce symptom burden and improve QOL.
  Aim 1: Describe the symptom trajectory and burden from the perspectives of patients, family
        caregivers, and health professionals and collectively develop a symptom management toolkit;
        and
  
        Aim 2: Refine and pilot test the nurse-driven symptom management toolkit/intervention to
        decrease the symptom burden and increase the QOL of critically ill adults with
        multimorbidity.
  
        Interventional study (Aim 2):
  
        The study aims to test the feasibility of the Care cOORDInatioN and sympTom managEment
        (COORDINATE) intervention developed from Aim 1 using an experienced-based co-design
        methodology. A single-arm feasibility study will be implemented with assumptions on the
        effectiveness of the COORDINATE intervention on outcomes such as symptom burden and quality
        of life will be evaluated.
  
        Sample and Setting:
  
        Individuals aged 55 years and older, living with two or more chronic health conditions, and
        willing to provide informed consent will be included in the study. The exclusion criteria
        include if participants cannot speak English or have a documented cognitive impairment that
        would prevent participation. Patients will be approached in the Intermediate Care Unit (IMCU)
        of an academic teaching hospital while the participants are in-patient before discharge.
  
        Intervention Components and Timing:
  
        The intervention consists of four components- i) needs assessment; ii) question prompt list;
        iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start
        with the enrolment of a patient living with multimorbidity. The intervention consists of one
        in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48
        hours, 1 week, 4 weeks, and 6 weeks post-discharge).
  
        Primary Outcomes
  
          1. Symptom Burden
  
          2. Quality of Life
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score
  time frame: Baseline, 6 weeks, and after completion of intervention up to 3 months
  description: The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).
  measure: Change in Quality of Life assessed by Short Form Survey (SF-36) score
  time frame: Baseline, 6 weeks, and after completion of intervention up to 3 months
  description: Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.
  measure: Change in Health-care utilization
  time frame: Baseline, 6 weeks, and after completion of intervention up to 3 months
  description: Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of hospitalizations, emergency visits and critical care admissions. Higher the numbers higher the healthcare utilization.
  arm group label: Intervention
  arm group type: Experimental
  description: A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention
  intervention type: Other
  intervention name: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention
  description: The intervention consists of the following four components: i) needs assessment; ii) question prompt list; iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start with the enrolment of a patient living with multimorbidity. The intervention consists of one in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge).
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Binu Koirala, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins School of Nursing
  last name: Binu Koirala, PhD
  phone: 410-614-4718
  email: bkoiral1@jhu.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor