<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/NCT04491201</url>
  </required_header>
  <id_info>
    <org_study_id>CMDA-SURVEY2</org_study_id>
    <nct_id>NCT04491201</nct_id>
  </id_info>
  <brief_title>National Survey of the Impact of COVID-19 Pandemics</brief_title>
  <acronym>CMDA-SURVEY2</acronym>
  <official_title>National Survey of the Impact of COVID-19 Pandemics on Chinese Physicians of Obstetrics and Gynecology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lei Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      COVID-19 pandemics have changed extensively the lives around the world. Although most&#xD;
      physicians of obstetrics and gynecology have no critical role in the frontline against&#xD;
      COVID-19 pandemics, their work, research and education activities still underwent great&#xD;
      changes. The primary aim of this study is to analyze change of workload during the COVID-19&#xD;
      pandemics in physicians of obstetrics and gynecology in China. A customized questionnaire&#xD;
      will be delivered by the social software WeChat to the specific hospital which has been&#xD;
      randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill&#xD;
      the questionnaire anonymously.&#xD;
&#xD;
      A random sampling will be performed in all 32 provinces, municipality or autonomous regions&#xD;
      in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and&#xD;
      the sample size under the condition of simple random sampling is 600 persons. If the&#xD;
      homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting&#xD;
      survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3,&#xD;
      the sample size of every level needs is 1800. Considering 10% population refusing to be&#xD;
      surveyed, in all mainland of China, three levels of hospitals will include at least 6000&#xD;
      physicians who accept survey.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">September 27, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 27, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The changes of workload of physicians during COVID-19 pandemics compared with 2019 year</measure>
    <time_frame>Six months</time_frame>
    <description>Reduction or augment in percentage of workload including outpatient clinics, surgeries, counseling and deliveries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The changes of education activities during COVID-19 pandemics compared with 2019 year</measure>
    <time_frame>Six months</time_frame>
    <description>Reduction or augment in percentage of education activities including lectures, ward rounds and exams.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of research activities during COVID-19 pandemics compared with 2019 year</measure>
    <time_frame>Six months</time_frame>
    <description>Reduction or augment in percentage of research activities including research protocol advancement, paper composition/submission/publication, and fund application</description>
  </secondary_outcome>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>COVID-19 Pandemics</condition>
  <condition>Obstetrics and Gynecology</condition>
  <condition>Workload</condition>
  <condition>Questionnaire</condition>
  <condition>National Survey</condition>
  <condition>China</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Customized questionnaire</intervention_name>
    <description>A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All physicians of obstetrics and gynecology from the hospitals randomly sampled&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years old&#xD;
&#xD;
          -  Belonging to and registered at specific hospital&#xD;
&#xD;
          -  Active employment in obstetrics, reproduction, or gynecology&#xD;
&#xD;
          -  Signed an approved informed consents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meeting all the inclusion criteria&#xD;
&#xD;
          -  Not completing the whole questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Lei Li, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li, M.D.</last_name>
    <phone>86-139-1198-8831</phone>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei Li, MD</last_name>
      <phone>8613911988831</phone>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04491201
org study id: CMDA-SURVEY2
nct id: NCT04491201
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 pandemics have changed extensively the lives around the world. Although most
      physicians of obstetrics and gynecology have no critical role in the frontline against
      COVID-19 pandemics, their work, research and education activities still underwent great
      changes. The primary aim of this study is to analyze change of workload during the COVID-19
      pandemics in physicians of obstetrics and gynecology in China. A customized questionnaire
      will be delivered by the social software WeChat to the specific hospital which has been
      randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill
      the questionnaire anonymously.

      A random sampling will be performed in all 32 provinces, municipality or autonomous regions
      in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and
      the sample size under the condition of simple random sampling is 600 persons. If the
      homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting
      survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3,
      the sample size of every level needs is 1800. Considering 10% population refusing to be
      surveyed, in all mainland of China, three levels of hospitals will include at least 6000
      physicians who accept survey.
observational model: Cohort
time perspective: Cross-Sectional
measure: The changes of workload of physicians during COVID-19 pandemics compared with 2019 year
time frame: Six months
description: Reduction or augment in percentage of workload including outpatient clinics, surgeries, counseling and deliveries
measure: The changes of education activities during COVID-19 pandemics compared with 2019 year
time frame: Six months
description: Reduction or augment in percentage of education activities including lectures, ward rounds and exams.
measure: The changes of research activities during COVID-19 pandemics compared with 2019 year
time frame: Six months
description: Reduction or augment in percentage of research activities including research protocol advancement, paper composition/submission/publication, and fund application
intervention type: Other
intervention name: Customized questionnaire
description: A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Lei Li, M.D.
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Lei Li, M.D.
phone: 86-139-1198-8831
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Professor
mesh term: COVID-19
sharing ipd: Undecided