COVID-19 Surveillance Based on Smart Wearable Device

NCT04459637 | Completed DMC

• 1 other identifier: 2020055-0615
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19 Surveillance Smart wearable device

Outcome Measures

Primary Outcomes (1)

• Deterioration of the condition

  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

  30 minutes

Secondary Outcomes (2)

• Mortality

  14days and/or 28days

• The information analysis degree, the proportion of signal loss, the proportion of wrong signal,

  30 minutes

Study Arms (5)

Asymptomatic group

Definition of asymptomatic disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)

Mild group

Definition of mild disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)

general-type group

Definition of general-type disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)

severe group

Definition of severe disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)

critical group

Definition of critical disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh Edition)

You may qualify if:

• Age between 18 and 75 years(both 18 and 75), either gender;
• At the time of enrollment, patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh Edition)
• Able to engage in daily activities;
• Willing to participate in this research and willing to follow the research program, with the ability to sign informed consent;
• having mobile communication equipment which can install APP of wearable device.

You may not qualify if:

• Wear time of wearable devices \<50% during the whole study period
• Wearable devices have faults, missing signals or errors throughout the study period, resulting in the proportion of analyzable information \<50%
• Patients with incomplete outpatient and inpatient information and missing core information such as hospitalization / discharge time, symptoms, laboratory examination, disease progress record, etc.
• 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
• Unable to take care of themselves in daily life, unable to cooperate with medical history and data collection
• participating in other clinical trials;
• Pregnant women, women in puerperium

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

• Zhang C, Sun A, Liao J, Zhang C, Yu K, Ma X, Wang G. COVID-19 surveillance based on consumer wearable devices. Digit Health. 2024 Apr 24;10:20552076241247374. doi: 10.1177/20552076241247374. eCollection 2024 Jan-Dec.

  PMID: 38665889 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & MD.

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: August 2, 2020
• Primary Completion: September 12, 2020
• Study Completion: April 15, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)