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

NCT04756869 | Completed

• 1 other identifier: HUM00180076
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

mobile health; wearable sensors; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Survey Completion Rate

  30 days

Other Outcomes (1)

• Clinical Health Outcomes

  2 years

Study Arms (1)

Health Care Workers at Risk for COVID-19

Health care workers at risk for COVID-19 will be monitored using wearing sensors and smartphone technology.

Other: COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology

Interventions

COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology OTHER

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.

Health Care Workers at Risk for COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Health care workers at Michigan Medicine at risk for COVID-19

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Clingan CA, Dittakavi M, Rozwadowski M, Gilley KN, Cislo CR, Barabas J, Sandford E, Olesnavich M, Flora C, Tyler J, Mayer C, Stoneman E, Braun T, Forger DB, Tewari M, Choi SW. Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology: Protocol for an Observational mHealth Study. JMIR Res Protoc. 2021 May 12;10(5):e29562. doi: 10.2196/29562.

  PMID: 33945497 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will provide self-collected nasal and saliva samples up to daily during the study period. These samples will be used to test for SARS-CoV-2, which will help to establish an estimate of the asymptomatic carrier frequency in the health care worker population. Subjects can also opt-in to providing blood samples at up to three time points within a year of enrollment, with a goal of determining baseline and changes in antibody titers to SARS-CoV-2, as well as obtaining specimens for the measurement of other immunologic parameters and biomarkers - including immune cell profiling and DNA/RNA-seq analysis. Subjects that receive a diagnosis of COVID-19 while on-study may provide additional nasal swabs, saliva, and/or blood specimens up to 1 year after study completion.

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 Officials

• Sung Choi, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 16, 2021
• Study Start: April 28, 2020
• Primary Completion: January 16, 2021
• Study Completion: January 16, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)