Stress and Recovery in Frontline COVID-19 Workers

NCT ID: NCT04713111

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-04

Study Completion Date

2020-11-30

Brief Summary

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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

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Conditions

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Covid19 Stress Wearables

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Lifestyle (Meditation)

Intervention Type 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 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.

Group Type OTHER

Lifestyle (Exercise)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Hair cortisol arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for International Emergency Medical Services

OTHER

Sponsor Role collaborator

Evidation Health

INDUSTRY

Sponsor Role collaborator

Vector Institute for Artificial Intelligence

UNKNOWN

Sponsor Role collaborator

Cambridge Cognition Ltd

INDUSTRY

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

4YouandMe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Friend, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

4YouandMe

Locations

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4YouandMe

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26938265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25289175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28815112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31372508 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34726607 (View on PubMed)

Other Identifiers

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4UCOVID1901

Identifier Type: -

Identifier Source: org_study_id

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