COVID-19 Surveillance Based on Smart Wearable Device

Completed

• Conditions: COVID-19

• Registration Number: NCT04459637
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Study Start: 2020-08-02
• Primary Completion: 2020-09-12
• Study Completion: 2021-04-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deterioration of the condition	30 minutes	Deterioration of the condition: refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7); 1. The development from asymptomatic to mild/general-type; 2. The development from mild to general-type/severe type; 3. The development from general-type to severe/critical type; 4. The development from severe to critical type

Secondary Outcome Measures

Name	Time	Method
Mortality	14days and/or 28days	Mortality within 14days and 28days after admission
The information analysis degree, the proportion of signal loss, the proportion of wrong signal,	30 minutes	The information analysis degree, the proportion of signal loss, the proportion of wrong signal

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China