Official Title
Surveillance of COVID-19 Using Smart Wearable Devices: a Prospective Study
Brief Summary

This is a prospective, multi-center cohort study. 200 subjects with COVID-19will be included . Wearable device's physiological parameters and clinical data will be continually collected , the investigators aim to explore whether using smart wearable devices is useful to early alerting deterioration of COVID-19.

Detailed Description

This is a prospective cohort study. 200 subjects aged 18~75y with asymptomatic, mild,
general-type COVID-19 will be recruited. The physiological parameters of wearable devices,
including heart rate, sleep, blood oxygen saturation, electrocardiogram and exercise records,
will be continuously collected from the day of admission / isolation to 14 days after
discharge or out of quarantine. The Department of Respiratory and Critical Care of Peking
University First Hospital is responsible for this research. All clinical data of patients
during hospitalization will be collected including demographic characteristics, onset time,
visit time, hospitalization time, symptoms, physical examination, laboratory examination,
imaging characteristics, disease severity, treatment and outcome. Primary outcome is the
deterioration of disease, the correlation analysis between the change of wearable device
physiological parameters and the deterioration of disease determined by the traditional
disease evaluation system will be used to find it whether can early alert deterioration of
COVID-19.

The study protocol has been approved by the Peking University First Hospital Institutional
Review Board (IRB) (2020-055). Any protocol modifications will be submitted for the IRB
review and approval.

Completed
COVID-19
Eligibility Criteria

Inclusion Criteria:

1. Age between 18 and 75 years(both 18 and 75), either gender;

2. At the time of enrollment, patients with novel coronavirus infection meeting the
criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh
Edition)

3. Able to engage in daily activities;

4. Willing to participate in this research and willing to follow the research program,
with the ability to sign informed consent;

5. having mobile communication equipment which can install APP of wearable device.

Exclusion Criteria:

1. Wear time of wearable devices <50% during the whole study period

2. Wearable devices have faults, missing signals or errors throughout the study period,
resulting in the proportion of analyzable information <50%

3. Patients with incomplete outpatient and inpatient information and missing core
information such as hospitalization / discharge time, symptoms, laboratory
examination, disease progress record, etc.

4. Patients with serious underlying diseases (including serious mental diseases, mental
disorders, nervous system diseases, malignant tumors, chronic liver diseases, heart
failure, autoimmune diseases, chronic kidney diseases), or life expectancy less than 6
months

5. Unable to take care of themselves in daily life, unable to cooperate with medical
history and data collection

6. participating in other clinical trials;

7. Pregnant women, women in puerperium

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
China
Locations

Peking University First Hospital
Beijing, Beijing, China

Peking University First Hospital
NCT Number
Keywords
COVID-19 Surveillance Smart wearable device
MeSH Terms
COVID-19