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Clinical Trials/NCT04713111
NCT04713111
Completed
N/A

Stress and Recovery in Frontline Healthcare COVID-19 Workers: A Feasibility Study Using Wearable and Smartphone Devices

4YouandMe1 site in 1 country383 target enrollmentMay 4, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
4YouandMe
Enrollment
383
Locations
1
Primary Endpoint
Study Retention
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The novel coronavirus (COVID-19) pandemic has caused an unprecedented stress on healthcare systems in affected countries, and in particular, on the healthcare workers at the frontline working directly with COVID-19 positive patients. Numerous lines of evidence support the damaging impact of stress on our immune systems which increases susceptibility to infection. Yet, the accurate measurement of immediate stress responses in real time and in naturalistic settings has so far been a challenge, limiting our understanding of how different facets of acute or sustained stress increases susceptibility. This study utilizes wearable technologies including an Oura smart ring as well as semi-continuous passive and active biometric measurements carried out using individuals' own smartphones equipped with applications to track and transmit key data to measure frontline workers stress and recovery during a uniquely stressful and high-risk work environment.

Registry
clinicaltrials.gov
Start Date
May 4, 2020
End Date
November 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
4YouandMe
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthcare workers working directly with COVID-19 patients, or whose work routines have been shifted from COVID-19
  • Age over 18 years
  • Able to speak, write and read English, given the app will be available only in English
  • Able to provide informed consent
  • Have a personal IOS mobile phone (OS11 and above).
  • Own a personal wearable device including a Fitbit, Garmin, or Oura ring (BYOD arm only)

Exclusion Criteria

  • Prior COVID-19 infection

Outcomes

Primary Outcomes

Study Retention

Time Frame: 4 months

Proportion of participants completing the study

Daily survey/task adherence

Time Frame: 4 months

Average completion of daily app-based surveys/tasks

Oura adherence

Time Frame: 4 months

Average usage of the Oura smartring during study follow-up

Garmin adherence

Time Frame: 4 months

Average usage of the Garmin smartwatch during study follow-up

Study Sites (1)

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