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OpenTrials
Completed

NCT Number: NCT04713111

Stress and Recovery in Frontline COVID-19 Workers

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Virus Diseases Wearables

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

4YouandMe

Seattle, Washington, 98121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle (Meditation)

Behavioral

Those in the meditation arm (exercisers) were instructed to complete meditation sessions from the smartphone app, Headspace 2 or more times a week for a duration of 4 weeks.

Lifestyle (Exercise)

Behavioral

Those in the physical activity arm (meditators) were instructed to complete 30 minutes to 1 hour of physical activity for 2 or more sessions per week for 4 weeks.

Primary outcomes

  1. Study Retention

    Time frame: 4 months

    Proportion of participants completing the study

  2. Daily survey/task adherence

    Time frame: 4 months

    Average completion of daily app-based surveys/tasks

  3. Oura adherence

    Time frame: 4 months

    Average usage of the Oura smartring during study follow-up

  4. Garmin adherence

    Time frame: 4 months

    Average usage of the Garmin smartwatch during study follow-up

Sponsors and collaborators

Lead sponsor

4YouandMe

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Cambridge Cognition Ltd
  • Center for International Emergency Medical Services
  • Evidation Health
  • Vector Institute for Artificial Intelligence

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2021
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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