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Stress and Recovery in Frontline COVID-19 Workers

Primary Purpose

Covid19, Stress, Wearables

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle (Meditation)
Lifestyle (Exercise)
Sponsored by
4YouandMe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19 focused on measuring stress, frontliner, covid19, wearables

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • 4YouandMe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

No Intervention

No Intervention

Arm Label

Lifestyle Intervention Group (Exercisers)

Lifestyle Intervention Group (Meditators)

Garmin wearable arm

Hair cortisol arm

Arm Description

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.

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.

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.

Interested existing stress and recovery participants were invited to participate in a one time hair sample collection for cortisol analysis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 8, 2021
Last Updated
March 10, 2021
Sponsor
4YouandMe
Collaborators
Center for International Emergency Medical Services, Evidation Health, Vector Institute for Artificial Intelligence, Cambridge Cognition Ltd, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04713111
Brief Title
Stress and Recovery in Frontline COVID-19 Workers
Official Title
Stress and Recovery in Frontline Healthcare COVID-19 Workers: A Feasibility Study Using Wearable and Smartphone Devices
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
4YouandMe
Collaborators
Center for International Emergency Medical Services, Evidation Health, Vector Institute for Artificial Intelligence, Cambridge Cognition Ltd, Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Stress, Wearables
Keywords
stress, frontliner, covid19, wearables

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
383 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention Group (Exercisers)
Arm Type
Other
Arm Description
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.
Arm Title
Lifestyle Intervention Group (Meditators)
Arm Type
Other
Arm Description
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.
Arm Title
Garmin wearable arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Hair cortisol arm
Arm Type
No Intervention
Arm Description
Interested existing stress and recovery participants were invited to participate in a one time hair sample collection for cortisol analysis.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle (Meditation)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle (Exercise)
Intervention Description
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 Outcome Measure Information:
Title
Study Retention
Description
Proportion of participants completing the study
Time Frame
4 months
Title
Daily survey/task adherence
Description
Average completion of daily app-based surveys/tasks
Time Frame
4 months
Title
Oura adherence
Description
Average usage of the Oura smartring during study follow-up
Time Frame
4 months
Title
Garmin adherence
Description
Average usage of the Garmin smartwatch during study follow-up
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Friend, PhD, MD
Organizational Affiliation
4YouandMe
Official's Role
Principal Investigator
Facility Information:
Facility Name
4YouandMe
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
26938265
Citation
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.
Results Reference
background
PubMed Identifier
25289175
Citation
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.
Results Reference
background
PubMed Identifier
28815112
Citation
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.
Results Reference
background
PubMed Identifier
31372508
Citation
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.
Results Reference
background
PubMed Identifier
34726607
Citation
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.
Results Reference
derived
Links:
URL
https://doi.org/10.1145/3292500.3330690
Description
Developing Measures of Cognitive Impairment in the Real World from Consumer-Grade Multimodal Sensor Stream

Learn more about this trial

Stress and Recovery in Frontline COVID-19 Workers

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