COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of a Self-test and Self-alert Mobile Applet in Detecting Susceptible Infection of COVID-19 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04256395
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Institute for precision medicine of Tsinghua University
Institute for artificial intelligent of Tsinghua University
Chinese Medical Doctor Association
Institute for network behavior of Tsinghua University
school of clinical medicine of Tsinghua University
Information provided by (Responsible Party):
Beijing Tsinghua Chang Gung Hospital

Tracking Information
First Submitted Date February 1, 2020
First Posted Date February 5, 2020
Last Update Posted Date July 7, 2020
Actual Study Start Date February 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2020)
positive number diagnosed by national guideline in the evaluated population [ Time Frame: 5 months ]
after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system
Original Primary Outcome Measures
 (submitted: February 3, 2020)
positive number diagnosed by national guideline in the evaluated population [ Time Frame: 5 months ]
after the end of this study, we calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system
Change History
Current Secondary Outcome Measures
 (submitted: February 5, 2020)
  • distribution map of evaluated people [ Time Frame: 5 month ]
    after the end of this study, investigators calculate the proportion and distribution of evaluated people with normal and abnormal scores
  • Effect of medical guidance by designated feedback questionnaire [ Time Frame: 5 month ]
    after the end of this study, investigators sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works.
  • mental scale of relief the mental anxiety and avoid unnecessary outpatient [ Time Frame: 5 month ]
    after the end of this study, investigators sent the designated mental scale including anxiety, and collect the response and draw the conclusion.
Original Secondary Outcome Measures
 (submitted: February 3, 2020)
  • distribution map of evaluated people [ Time Frame: 5 month ]
    after the end of this study, we calculate the proportion and distribution of evaluated people with normal and abnormal scores
  • Effect of medical guidance by designated feedback questionnaire [ Time Frame: 5 month ]
    after the end of this study, we sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works.
  • mental scale of relief the mental anxiety and avoid unnecessary outpatient [ Time Frame: 5 month ]
    after the end of this study, we sent the designated mental scale including anxiety, and collect the response and draw the conclusion.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of a Self-test and Self-alert Mobile Applet in Detecting Susceptible Infection of COVID-19
Official Title Registry Study on the Efficacy of a Self-test and Self-alert Applet in Detecting Susceptible Infection of COVID-19 --a Population Based Mobile Internet Survey
Brief Summary The "COVID-19 infection self-test and alert system" (hereinafter referred to as "COVID-19 self-test applet") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1,2020. Residents , according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People's Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.
Detailed Description The "COVID-19 infection self-test and alert system" (hereinafter referred to as "COVID-19 self-test applet") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1,2020. This survey was also advocated by Chinese Medical Doctor Association. Residents , or even oversea Chinese people,according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People's Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Most people including healthy or susceptible patients or diagnosed patients will be enrolled. People whoever worry about his heath status relating with infection of COVID-19 at present can register and answer the question and get a score for risk evaluation. If a high risk achieved, the applet will guide the interviewer for further medical diagnosis and treatment.
Condition Susceptibility to Viral and Mycobacterial Infection
Intervention Other: mobile internet survey on self-test
1. make a questionnaire, the content of which refers to the new coronavirus diagnosis and treatment guidelines released by the National Health Commission; 2. develop the mobile applet and carry out internet propagation; 3. background data could be identified according to computer technology, de duplication and de privacy; 4. once registered, the applet can automatically remind the self-test twice a day, and encourage to adhere to 14 days; 5. automatically compare with the standards and highly suspected population could be given medical guidance and encouraged to go to the fever clinic of the designated hospital for definite diagnosis.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 5, 2020)
102456
Original Estimated Enrollment
 (submitted: February 3, 2020)
100000
Actual Study Completion Date July 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • people who lived in or out of China at present and threatened by the infection and spread of COVID-19

    • without gender and age restriction
    • people who have concerns of his health
    • voluntary completion of the self-test and evaluation.

Exclusion Criteria:

  • people who are not internet accessible or can not use this Mobile Applet.
  • people who can not recognize the questionnaire.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04256395
Other Study ID Numbers RWS-BTCH-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Beijing Tsinghua Chang Gung Hospital
Study Sponsor Beijing Tsinghua Chang Gung Hospital
Collaborators
  • Institute for precision medicine of Tsinghua University
  • Institute for artificial intelligent of Tsinghua University
  • Chinese Medical Doctor Association
  • Institute for network behavior of Tsinghua University
  • school of clinical medicine of Tsinghua University
Investigators
Principal Investigator: Jiahong Dong, M.D Beijing Tsinghua Changgung Hospital
PRS Account Beijing Tsinghua Chang Gung Hospital
Verification Date July 2020