Clinical trial NCT04713111: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Stress
Wearables
Keywords: stress
frontliner
covid19
wearables
Lead sponsor: 4YouandMe
Sponsor class: OTHER
Collaborators: name: Center for International Emergency Medical Services
name: Evidation Health
name: Vector Institute for Artificial Intelligence
name: Cambridge Cognition Ltd
name: Bill and Melinda Gates Foundation
First posted: 2021-01-19
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Study Retention
timeFrame: 4 months
measure: Daily survey/task adherence
timeFrame: 4 months
measure: Oura adherence
timeFrame: 4 months
measure: Garmin adherence
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: 4YouandMe
state: Washington
Study officials:
affiliation: 4YouandMe
name: Stephen Friend, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.