Stress and Recovery in Frontline COVID-19 Workers

Not Applicable

Completed

• Conditions: Wearables; Stress; Covid19
• Interventions: Behavioral: Lifestyle (Exercise); Behavioral: Lifestyle (Meditation)

• Registration Number: NCT04713111
• Lead Sponsor: 4YouandMe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-04
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention Group (Meditators)	Lifestyle (Exercise)	All Interested and enrolled participants in the main Stress and Recovery were invited to participate in a lifestyle intervention arm. Participants were instructed to self-select into either a physical activity arm, or a meditation arm. Participants were excluded if they were already partaking in both regular physical exercise, and meditation. 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.
Lifestyle Intervention Group (Exercisers)	Lifestyle (Meditation)	All Interested and enrolled participants in the main Stress and Recovery were invited to participate in a lifestyle intervention arm. Participants were instructed to self-select into either a physical activity arm, or a meditation arm. Participants were excluded if they were already partaking in both regular physical exercise, and meditation. 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.

Primary Outcome Measures

Name	Time	Method
Study Retention	4 months	Proportion of participants completing the study
Daily survey/task adherence	4 months	Average completion of daily app-based surveys/tasks
Oura adherence	4 months	Average usage of the Oura smartring during study follow-up
Garmin adherence	4 months	Average usage of the Garmin smartwatch during study follow-up

Trial Locations

Locations (1)

4YouandMe; 🇺🇸 Seattle, Washington, United States