Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology

Covid19 Clinical Trial

Official title:

Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756869
• Other study ID #: HUM00180076
• Status: Completed
• Start date: April 28, 2020
• Est. completion date: January 16, 2021

Study information

• Verified date: February 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective study of health care workers utilizes wearable sensors, surveys and symptom logs, and biospecimens in an effort to improve self-monitoring practices for COVID-19 among health care workers and to provide key data for the development of a predictive model for early detection of COVID-19 infection.

Description:

Health care workers work on the front lines of the COVID-19 pandemic, so early detection of COVID-19 infection is especially important in this population in order to prevent the spread of disease among the health care workforce, their patients, and their families. However, standard symptomatic COVID-19 testing is insufficient to protect health care workers and prevent the spread of disease. This study utilizes continuous physiological data from wearable sensors and surveys completed via smartphone technology, in conjunction with biospecimens, in order to assist health care workers in their self-monitoring for COVID-19 infection. Subjects will wear smart watches and temperature monitoring patches to collect continuous heart rate and temperature data. Subjects will also complete baseline and exit surveys, in addition to daily mood and symptom logging surveys. Finally, subjects will provide biospecimens - nasal and saliva samples and optional blood samples. Using wearable sensor data in conjunction with survey data and biospecimens, this study aims to prevent the spread of COVID-19 among health care workers, their patients, and their families, and to eventually develop a predictive model for early detection of COVID-19 infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 16, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Michigan Medicine health care workers age 18 years and older.

• Health care workers who are involved in direct (in-person) face-to-face patient care or health care workers who are not involved in direct (in-person) face-to-face patient care but work on units where COVID-19 patients are/will likely be treated.

• Possession of a smartphone (Apple or Android).

• Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion Criteria:

• Unwilling or unable to comply with the study procedures or to allow the study team access to health data.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology
Health care workers are on-study for 30 days, in which they wear a smart watch and temperature patches up to daily. Subjects also may provide nasal and saliva samples up to daily during the study period, and they may opt-in to blood samples lasting up to 1 year after study completion. Through a smartphone app, participants complete surveys at baseline and at study completion, as well as daily mood surveys and symptom-reporting surveys. Finally, exit interviews occur at the end of the study period, and follow-up interviews may occur at specified timepoints up to 1 year after study completion.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Health Outcomes	Detection of SARS-CoV-2 using any of the following: biospecimens, self-reported test results, a database of COVID-19 testing and results maintained in Employee Health at Michigan Medicine, and subjects' electronic medical records	2 years
Primary	Feasibility of Wearing Fitbit Watch	Feasibility is defined as wearing the Fitbit Watch for at least 8 hours a day, 5 days a week (~40 hours/week or 160 hours/30 days).	30 days
Primary	Feasibility of Wearing TempTraq Patch	Feasibility is defined as wearing the TempTraq for at least 8 hours a day, five days a week (~40 hours/week or 160 hours/30 days).	30 days
Secondary	Survey Completion Rate	This outcome is measured by the percentage of subjects that complete their surveys, estimating that at least 50% of subjects will complete the baseline and exit surveys, and at least 50% of subjects will complete at least 50% of the daily symptom surveys.	30 days