Stress and Recovery in Frontline COVID-19 Workers

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713111
• Other study ID #: 4UCOVID1901
• Status: Completed
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: 4YouandMe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Stress
• Wearables

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	4YouandMe	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
4YouandMe	Bill and Melinda Gates Foundation, Cambridge Cognition Ltd, Center for International Emergency Medical Services, Evidation Health, Vector Institute for Artificial Intelligence

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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

External Links

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