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

July 5, 2020 updated by: Beijing Tsinghua Chang Gung Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Enrollment (Actual)

102456

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 102218
        • Beijing Tsinghua Changgung Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 month
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.
5 month
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.
5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Collaborators

Chinese Medical Doctor Association
Institute for precision medicine of Tsinghua University
Institute for artificial intelligent of Tsinghua University
Institute for network behavior of Tsinghua University
school of clinical medicine of Tsinghua University

Investigators

  • Principal Investigator: Jiahong Dong, M.D, Beijing Tsinghua Changgeng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

February 1, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 5, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RWS-BTCH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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