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/NCT06028568</url>
    </required_header>
    <id_info>
      <org_study_id>KY20232188-C-1</org_study_id>
      <nct_id>NCT06028568</nct_id>
    </id_info>
    <brief_title>The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Neurocognitive Changes</brief_title>
    <official_title>The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Perioperative Neurocognitive Function Changes in Patients Undergoing Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xijing 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>
        This study aimed to analyze the reliability and validity of the results of the new designed&#xD;
        perioperative cognitive test network platform, and to judge the reliability and scientific&#xD;
        nature of the perioperative cognitive test. And then to explore whether the perioperative&#xD;
        cognitive test network platform can be used to evaluate the changes of perioperative&#xD;
        cognitive function of patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery&#xD;
        will be included in this study. The cognitive function of the patients was tested one day&#xD;
        before and seven days after operation. Healthy volunteers had two cognitive function tests at&#xD;
        the same interval. The normality test is used to evaluate whether the test results accord&#xD;
        with the normal distribution. The internal consistency of the test was evaluated by&#xD;
        calculating the Cronbach coefficient, the content validity was evaluated by experts and the&#xD;
        content validity index was calculated, and the construct validity of the test was evaluated&#xD;
        by exploratory factor analysis and confirmatory factor analysis. The validity of the test was&#xD;
        evaluated by calculating the effect scale.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Reliability</measure>
      <time_frame>Baseline Test：1 day before operation, Second Test: Day 7 after operation</time_frame>
      <description>Cronbach's alpha is used to assess the reliability and the internal consistency of this Cognitive test.&#xD;
  Cronbach's alpha value &gt;0.7 indicating the reliability of the test is acceptable.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Validity</measure>
      <time_frame>Baseline Test：1 day before operation, Second Test: Day 7 after operation</time_frame>
      <description>Content validity, Construct validity and Responsiveness analysis are used to evaluate the validity of the cognitive test.&#xD;
  The item-content validity index (I-cvi) is used evaluate the Content validity. I-cvi≥ 0.78 means the content validity is satisfactory.&#xD;
  The Exploratory Factor Analysis (EFA) is used evaluate the Construct validity. The Kaiser-Mayer-Olkin (KMO) index (&gt;0.6) is used to evaluate adaptability for factor analysis. Factor loading should &gt;0.4.&#xD;
  The Responsiveness analysis is used to evaluate the ability of this cognitive test that can reflect the change of cognitive function of the Interviewer during operation. Paired t-test can be used to compare whether the difference in score before and after is statistically significant. P value should &lt; 0.05.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PND (Perioperative neurocognitive disorders)</measure>
      <time_frame>Baseline Test：1 day before operation, Second Test: Day 7 after operation</time_frame>
      <description>PND is diagnosed by calculating the Z-score. The investigators get the score or accuracy and completion time of each test through the cognitive test network platform.&#xD;
  Then Calculate Z-score: For each test, the mean practice effect is subtracted from the difference between preoperative and postoperative test scores; the result is then divided by the control group standard deviation to obtain a z-score. The z-scores of all tests in an individual patient are summarized and divided by the standard deviations for this sum of z-scores in the control subjects, creating a composite z-score.&#xD;
  Cognitive decline is defined when two z-scores in individual tests or the composite z-score ≤-1.96.&#xD;
  Perioperative neurocognitive disorders (PND) mainly refer to neurocognitive decline detected after surgery and anesthesia.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Perioperative Neurocognitive Disorders</condition>
    <arm_group>
      <arm_group_label>Elderly patients undergoing surgery</arm_group_label>
      <description>Older than or equal to 65 years of age; patients who intend to undergo major abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Elderly healthy volunteers</arm_group_label>
      <description>Age-and sex-matched community population</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This study will include two groups: elderly healthy volunteers and elderly patients&#xD;
          undergoing abdominal surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age over 65&#xD;
  &#xD;
            -  Scheduled for abdominal surgery under general anesthesia (grade 3-4 surgery based on&#xD;
               surgical grade)&#xD;
  &#xD;
            -  Informed consent has been obtained&#xD;
  &#xD;
            -  Healthy volunteer groups are listed as age-and sex-matched community groups&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to follow instruction and finish the firtst procedure&#xD;
  &#xD;
            -  Has severe visual or auditory problems&#xD;
  &#xD;
            -  History of drug or alcohol abuse (drinking more than 5U daily in the past 3 months, 1U&#xD;
               equals 10ml or 8g pure alcohol, equivalent to &gt;50 liquor over 100ml, two two&#xD;
  &#xD;
            -  Are diagnosed neuropsychological disease that needs treatment&#xD;
  &#xD;
            -  Clear history of severe cerebrovascular diseases (including cerebral hemorrhage and&#xD;
               cerebral infarction), Parkinson's syndrome, schizophrenia, bipolar disorder,&#xD;
               depression, dementia, Alzheimer's disease, etc&#xD;
  &#xD;
            -  Severe head trauma, carbon monoxide poisoning and other loss of consciousness more&#xD;
               than 30 minutes&#xD;
  &#xD;
            -  MMSE score ≤23&#xD;
  &#xD;
            -  Participated this study or being participating other clinical research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zhixin Wu, physician</last_name>
      <phone>18392187971</phone>
      <email>wuzhixin212@163.com</email>
    </overall_contact>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neurocognitive Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06028568
  org study id: KY20232188-C-1
  nct id: NCT06028568
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to analyze the reliability and validity of the results of the new designed
        perioperative cognitive test network platform, and to judge the reliability and scientific
        nature of the perioperative cognitive test. And then to explore whether the perioperative
        cognitive test network platform can be used to evaluate the changes of perioperative
        cognitive function of patients.
  Two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery
        will be included in this study. The cognitive function of the patients was tested one day
        before and seven days after operation. Healthy volunteers had two cognitive function tests at
        the same interval. The normality test is used to evaluate whether the test results accord
        with the normal distribution. The internal consistency of the test was evaluated by
        calculating the Cronbach coefficient, the content validity was evaluated by experts and the
        content validity index was calculated, and the construct validity of the test was evaluated
        by exploratory factor analysis and confirmatory factor analysis. The validity of the test was
        evaluated by calculating the effect scale.
  observational model: Ecologic or Community
  time perspective: Prospective
  measure: Reliability
  time frame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
  description: Cronbach's alpha is used to assess the reliability and the internal consistency of this Cognitive test.
  Cronbach's alpha value >0.7 indicating the reliability of the test is acceptable.
  measure: Validity
  time frame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
  description: Content validity, Construct validity and Responsiveness analysis are used to evaluate the validity of the cognitive test.
  The item-content validity index (I-cvi) is used evaluate the Content validity. I-cvi≥ 0.78 means the content validity is satisfactory.
  The Exploratory Factor Analysis (EFA) is used evaluate the Construct validity. The Kaiser-Mayer-Olkin (KMO) index (>0.6) is used to evaluate adaptability for factor analysis. Factor loading should >0.4.
  The Responsiveness analysis is used to evaluate the ability of this cognitive test that can reflect the change of cognitive function of the Interviewer during operation. Paired t-test can be used to compare whether the difference in score before and after is statistically significant. P value should < 0.05.
  measure: PND (Perioperative neurocognitive disorders)
  time frame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
  description: PND is diagnosed by calculating the Z-score. The investigators get the score or accuracy and completion time of each test through the cognitive test network platform.
  Then Calculate Z-score: For each test, the mean practice effect is subtracted from the difference between preoperative and postoperative test scores; the result is then divided by the control group standard deviation to obtain a z-score. The z-scores of all tests in an individual patient are summarized and divided by the standard deviations for this sum of z-scores in the control subjects, creating a composite z-score.
  Cognitive decline is defined when two z-scores in individual tests or the composite z-score ≤-1.96.
  Perioperative neurocognitive disorders (PND) mainly refer to neurocognitive decline detected after surgery and anesthesia.
  arm group label: Elderly patients undergoing surgery
  description: Older than or equal to 65 years of age; patients who intend to undergo major abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)
  arm group label: Elderly healthy volunteers
  description: Age-and sex-matched community population
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zhixin Wu, physician
  phone: 18392187971
  email: wuzhixin212@163.com
  responsible party type: Sponsor
  mesh term: Neurocognitive Disorders