Stress and Recovery in Frontline COVID-19 Workers

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Stress; Wearables
• Intervention / Treatment: Behavioral: Lifestyle (Meditation); Behavioral: Lifestyle (Exercise)

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98121
      • 4YouandMe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lifestyle Intervention Group (Exercisers); 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.	Behavioral: Lifestyle (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.
Other: Lifestyle Intervention Group (Meditators); 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.	Behavioral: Lifestyle (Exercise); 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.
No Intervention: Garmin wearable arm; Existing stress and recovery participants were invited to participate in a Garmin wearable arm where they were provided a Garmin Vivoactive 4 smartwatch to wear continuously, and in particular, while they were on shift at work for a total of 4 consecutive weeks.
No Intervention: Hair cortisol arm; Interested existing stress and recovery participants were invited to participate in a one time hair sample collection for cortisol analysis.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 4YouandMe
• Collaborators: Bill and Melinda Gates Foundation; Cambridge Cognition Ltd; Evidation Health; Center for International Emergency Medical Services; Vector Institute for Artificial Intelligence
• Investigators: Principal Investigator: Stephen Friend, PhD, MD, 4YouandMe

Publications and helpful links

General Publications

• Bot BM, Suver C, Neto EC, Kellen M, Klein A, Bare C, Doerr M, Pratap A, Wilbanks J, Dorsey ER, Friend SH, Trister AD. The mPower study, Parkinson disease mobile data collected using ResearchKit. Sci Data. 2016 Mar 3;3:160011. doi: 10.1038/sdata.2016.11.
• Ghassemi M, Naumann T, Doshi-Velez F, Brimmer N, Joshi R, Rumshisky A, Szolovits P. Unfolding Physiological State: Mortality Modelling in Intensive Care Units. KDD. 2014 Aug 24;2014:75-84. doi: 10.1145/2623330.2623742.
• Ghassemi M, Wu M, Hughes MC, Szolovits P, Doshi-Velez F. Predicting intervention onset in the ICU with switching state space models. AMIA Jt Summits Transl Sci Proc. 2017 Jul 26;2017:82-91. eCollection 2017.
• Goodday SM, Friend S. Unlocking stress and forecasting its consequences with digital technology. NPJ Digit Med. 2019 Jul 31;2:75. doi: 10.1038/s41746-019-0151-8. eCollection 2019.
• Goodday SM, Karlin E, Alfarano A, Brooks A, Chapman C, Desille R, Rangwala S, Karlin DR, Emami H, Woods NF, Boch A, Foschini L, Wildman M, Cormack F, Taptiklis N, Pratap A, Ghassemi M, Goldenberg A, Nagaraj S, Walsh E; Stress And Recovery Participants; Friend S. An Alternative to the Light Touch Digital Health Remote Study: The Stress and Recovery in Frontline COVID-19 Health Care Workers Study. JMIR Form Res. 2021 Dec 10;5(12):e32165. doi: 10.2196/32165. Erratum In: JMIR Form Res. 2022 Apr 18;6(4):e38188.

Helpful Links

• Developing Measures of Cognitive Impairment in the Real World from Consumer-Grade Multimodal Sensor Stream

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: stress; covid19; wearables; frontliner
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 4UCOVID1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Under the 4YouandMe open source model, we will make all data, findings, digital health applications and algorithms available in the public domain. Accordingly, de-identified data produced from this project will be shared broadly with qualified researchers (among participants who opt in) through Sage Bionetworks Synapse and will serve as an immense resource, reflecting a highly granular and high- dimensional map of physiological stress responses and knowledge surrounding inadvertent consequences of objective stress measurement. Only data from consenting participants will be shared through Sage Bionetworks Synapse. Additionally, Source code for the developed app will be made available as open source software on GitHub so it can be evolved for future work by others.
• IPD Sharing Time Frame: Internal collaborative researchers will have access to all coded data during the full duration of the study. Consented participants' coded data will be available in the Synapse at Sage Bionetworks for selected researchers to access indefinitely, one year after study completion.
• IPD Sharing Access Criteria: As coded study data will then exist among consenting participants in the Synapse at Sage Bionetworks in de-identified form, the electronic data files will be kept indefinitely. The Principal Investigator will be responsible for receipt and/or transmission of data as required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No