NCT04713111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

March 12, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

January 8, 2021

Last Update Submit

March 10, 2021

Conditions

Covid19StressWearables

Keywords

stressfrontlinercovid19wearables

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (4)

Lifestyle Intervention Group (Exercisers)

OTHER

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)

Lifestyle Intervention Group (Meditators)

OTHER

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)

Garmin wearable arm

NO INTERVENTION

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.

Hair cortisol arm

NO INTERVENTION

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

Interventions

Lifestyle (Meditation)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 (Exercisers)
Lifestyle (Exercise)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.

Lifestyle Intervention Group (Meditators)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • \- Prior COVID-19 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4YouandMe

Seattle, Washington, 98121, United States

Location

Related Publications (5)

  • 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.

    PMID: 26938265BACKGROUND

  • 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.

    PMID: 25289175BACKGROUND

  • 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.

    PMID: 28815112BACKGROUND

  • 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.

    PMID: 31372508BACKGROUND

  • 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.

    PMID: 34726607DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

MeditationExercise

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephen Friend, PhD, MD

    4YouandMe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 19, 2021

Study Start

May 4, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

March 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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.

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.
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.

Locations

US(1)