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/NCT05987267</url>
    </required_header>
    <id_info>
      <org_study_id>K2019-017</org_study_id>
      <nct_id>NCT05987267</nct_id>
    </id_info>
    <brief_title>Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure</brief_title>
    <official_title>Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongshan People's Hospital, Guangdong, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongshan People's Hospital, Guangdong, China</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>
        This study aimed to evaluate the feasibility and effectiveness of a nurse-led&#xD;
        multidisciplinary precision care in early cardiac rehabilitation of patients with chronic&#xD;
        heart failure, and further to promote the application of nurse-led multidisciplinary&#xD;
        precision care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Enrolled patients were randomly divided as 1:1 ratio to experimental group and control group,&#xD;
        while experimental group received nurse-led multidisciplinary precision care and the control&#xD;
        group received standard care according to guidelines. The primary and secondary outcomes were&#xD;
        evaluated and analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 24, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Actual">April 10, 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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>left ventricular ejection fraction</measure>
      <time_frame>baseline, pre-intervention, 1 month after intervention, 3 months after intervention</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>6-minute walking distance</measure>
      <time_frame>baseline, pre-intervention, 1 month after intervention, 3 months after intervention</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires (QLQ) QLQ-C30 (version 3.0) score Quality of Life</measure>
      <time_frame>baseline, pre-intervention, 1 month after intervention, 3 months after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptom Check List-90</measure>
      <time_frame>baseline, pre-intervention, 1 month after intervention, 3 months after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance Status Score</measure>
      <time_frame>baseline, pre-intervention, 1 month after intervention, 3 months after intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numbers of patients with cardiovascular complications</measure>
      <time_frame>baseline, pre-intervention, 1 month after intervention, 3 months after intervention</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Nurse's Role</condition>
    <condition>Multidisciplinary Communication</condition>
    <condition>Chronic Heart Failure</condition>
    <arm_group>
      <arm_group_label>multidisciplinary precision care group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Give the intervention of nurse-led multidisciplinary precision care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>standard care according to guidelines</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>multidisciplinary precision care</intervention_name>
      <description>The experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care</description>
      <arm_group_label>multidisciplinary precision care group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged from 18 to 80 years;&#xD;
  &#xD;
            -  Conscious, with normal cognitive function and being communicable;&#xD;
  &#xD;
            -  NYHA heart function class II-IV;&#xD;
  &#xD;
            -  Patients met the diagnostic criteria of the clinical guidelines for the diagnosis and&#xD;
               treatment of heart failure and were diagnosed with chronic heart failure;&#xD;
  &#xD;
            -  Informed consent was obtained.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with congenital heart disease, cardiac shock, or persistent hypotension;&#xD;
  &#xD;
            -  Patients with severe liver and kidney dysfunction, moderate to severe anemia or&#xD;
               coagulation disorders, and other serious systemic complications;&#xD;
  &#xD;
            -  Patients with a history of mental illness, a state of severe anxiety or depression,&#xD;
               cognitive or communication impairments, and inability to communicate and respond to&#xD;
               investigations;&#xD;
  &#xD;
            -  Patients have been involved in other research that would interfere with this study;&#xD;
  &#xD;
            -  Patients who declined cardiac rehabilitation and signed informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiuxian Zhu</last_name>
      <role>Study Chair</role>
      <affiliation>Zhongshan People's Hospital, Guangdong, China</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Zhongshan City People's Hospital</name>
        <address>
          <city>Zhongshan</city>
          <state>Guangdong</state>
          <zip>528400</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongshan People's Hospital, Guangdong, China</investigator_affiliation>
      <investigator_full_name>Xiuxian Zhu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05987267
  org study id: K2019-017
  nct id: NCT05987267
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to evaluate the feasibility and effectiveness of a nurse-led
        multidisciplinary precision care in early cardiac rehabilitation of patients with chronic
        heart failure, and further to promote the application of nurse-led multidisciplinary
        precision care.
  Enrolled patients were randomly divided as 1:1 ratio to experimental group and control group,
        while experimental group received nurse-led multidisciplinary precision care and the control
        group received standard care according to guidelines. The primary and secondary outcomes were
        evaluated and analyzed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: left ventricular ejection fraction
  time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
  measure: 6-minute walking distance
  time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
  measure: the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires (QLQ) QLQ-C30 (version 3.0) score Quality of Life
  time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
  measure: Symptom Check List-90
  time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
  measure: Performance Status Score
  time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
  measure: Numbers of patients with cardiovascular complications
  time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
  arm group label: multidisciplinary precision care group
  arm group type: Experimental
  description: Give the intervention of nurse-led multidisciplinary precision care
  arm group label: control group
  arm group type: No Intervention
  description: standard care according to guidelines
  intervention type: Other
  intervention name: multidisciplinary precision care
  description: The experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care
  arm group label: multidisciplinary precision care group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Xiuxian Zhu
  role: Study Chair
  affiliation: Zhongshan People's Hospital, Guangdong, China
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongshan People's Hospital, Guangdong, China
  investigator full name: Xiuxian Zhu
  investigator title: Principal Investigator
  mesh term: Heart Failure
  sharing ipd: No