<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/NCT03792373</url>
  </required_header>
  <id_info>
    <org_study_id>HELP</org_study_id>
    <nct_id>NCT03792373</nct_id>
  </id_info>
  <brief_title>Hospital Ederly Life Program for Surgical Patients</brief_title>
  <official_title>Effects of Frailty on Outcomes After Elective Noncardiac Surgery -a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongda Hospital</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>
      Frailty is the clinically recognizable medical condition, also called syndrome or phenotype,&#xD;
      that is, the result of processes leading to an increased vulnerability for serious&#xD;
      deteriorations in health and the diminished ability to cope with physical stressors.&#xD;
      Recently, frailty has emerged as a significant risk factor for adverse postoperative&#xD;
      outcomes. It is related to declines in energy, strength, and function as well as to an&#xD;
      increased inflammatory state, including elevated levels of interleukin 6 (IL-6), C-reactive&#xD;
      protein (CRP), and anelevated white blood cell count . Frailty, as defined Frailty, as&#xD;
      defined in the landmark paper by Fried, included at least three of five of the following&#xD;
      criteria: unintentional loss of weight, low physical activity, low energy, low grip strength,&#xD;
      and a slowed walking speed. Since then, various frailty scoring lists have been designed to&#xD;
      optimize the predictive value. One of these is the Edmonton Frail Scale (EFS), an instrument&#xD;
      that can be assessed quickly, using only a simple questionnaire which usually does not&#xD;
      require more than five minutes to be completed and which covers most domains of functioning,&#xD;
      making it easy and fast to get a reliable impression of the degree of frailty.The aim of this&#xD;
      study was to determine which factors,with emphasis on frailty, significantly influence&#xD;
      postoperative outcome after elective noncardiac surgery as measured by the Comprehensive&#xD;
      Complication Index (CCI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>one-year mortality</measure>
    <time_frame>2019.02-2020.02</time_frame>
    <description>To investigate the one-year mortality of the frailty patients</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>To Investigate the Mortality of the Frailty Patients</condition>
  <arm_group>
    <arm_group_label>frailty</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>nonfrailty</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        ≥65 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective noncardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who don't cooperate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gaojun Teng, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Zhongda Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoyun Sun, Master</last_name>
    <phone>18752009886</phone>
    <email>977988901@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongda Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Jian-jun</last_name>
      <phone>13357739238</phone>
      <email>yjyangjj@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
    <investigator_full_name>Jian-jun Yang</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>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03792373
org study id: HELP
nct id: NCT03792373
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Frailty is the clinically recognizable medical condition, also called syndrome or phenotype,
      that is, the result of processes leading to an increased vulnerability for serious
      deteriorations in health and the diminished ability to cope with physical stressors.
      Recently, frailty has emerged as a significant risk factor for adverse postoperative
      outcomes. It is related to declines in energy, strength, and function as well as to an
      increased inflammatory state, including elevated levels of interleukin 6 (IL-6), C-reactive
      protein (CRP), and anelevated white blood cell count . Frailty, as defined Frailty, as
      defined in the landmark paper by Fried, included at least three of five of the following
      criteria: unintentional loss of weight, low physical activity, low energy, low grip strength,
      and a slowed walking speed. Since then, various frailty scoring lists have been designed to
      optimize the predictive value. One of these is the Edmonton Frail Scale (EFS), an instrument
      that can be assessed quickly, using only a simple questionnaire which usually does not
      require more than five minutes to be completed and which covers most domains of functioning,
      making it easy and fast to get a reliable impression of the degree of frailty.The aim of this
      study was to determine which factors,with emphasis on frailty, significantly influence
      postoperative outcome after elective noncardiac surgery as measured by the Comprehensive
      Complication Index (CCI).
observational model: Cohort
time perspective: Prospective
measure: one-year mortality
time frame: 2019.02-2020.02
description: To investigate the one-year mortality of the frailty patients
arm group label: frailty
arm group label: nonfrailty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gaojun Teng, PhD
role: Study Chair
affiliation: Zhongda Hospital
last name: Xiaoyun Sun, Master
phone: 18752009886
email: 977988901@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongda Hospital
investigator full name: Jian-jun Yang
investigator title: Principal Investigator
mesh term: Frailty
sharing ipd: Undecided