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

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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

Study Description
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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.

Condition or disease Intervention/treatment
Susceptibility to Viral and Mycobacterial Infection Other: mobile internet survey on self-test

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 Design
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Study Type : Observational
Actual Enrollment : 102456 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256395


Locations
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China, Beijing
Beijing Tsinghua Changgung Hospital
Beijing, Beijing, China, 102218
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
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
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Principal Investigator: Jiahong Dong, M.D Beijing Tsinghua Changgung Hospital
More Information
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Additional Information:

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Responsible Party: Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT04256395    
Other Study ID Numbers: RWS-BTCH-002
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tsinghua Chang Gung Hospital:
registry study
novel coronavirus（COVID-19）
mobile internet survey
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Mycobacterium Infections
Disease Susceptibility
Disease Attributes
 Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections