Covid19NCT04713111
Stress and Recovery in Frontline COVID-19 Workers
A study testing Lifestyle (Meditation) and Lifestyle (Exercise) in people with Covid19 and Stress, run by 4YouandMe at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Lifestyle (Meditation) and Lifestyle (Exercise)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Prior COVID-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress and Recovery in Frontline Healthcare COVID-19 Workers: A Feasibility Study Using Wearable and Smartphone Devices
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.
- Being tested
- Lifestyle (Meditation), Lifestyle (Exercise)
- Keywords
- stress, frontliner, covid19, wearables
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle (Meditation)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Retention
Proportion of participants completing the study
Measured: 4 months
Daily survey/task adherence
Average completion of daily app-based surveys/tasks
Measured: 4 months
Oura adherence
Average usage of the Oura smartring during study follow-up
Measured: 4 months
Garmin adherence
Average usage of the Garmin smartwatch during study follow-up
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start4 May 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4YouandMe
- Sponsor type
- University, hospital or other
- Collaborators
- Center for International Emergency Medical Services, Evidation Health, Vector Institute for Artificial Intelligence, Cambridge Cognition Ltd, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Stephen Friend, PhD, MD, Principal investigator, 4YouandMe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713111
- Sponsor's protocol ID
- 4UCOVID1901
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26938265Ghassemi 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.
PubMed 25289175Ghassemi 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.
PubMed 28815112Goodday 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.
PubMed 31372508Goodday 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.
PubMed 34726607
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Recovery in Frontline Healthcare COVID-19 Workers: A Feasibility Study Using Wearable and Smartphone Devices
- ClinicalTrials.gov ID
- NCT04713111
- Acronym / sponsor ID
- 4UCOVID1901
- Keywords
- stress, frontliner, covid19, wearables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- 4YouandMeUniversity, hospital or other
- Collaborators
- Center for International Emergency Medical Services, Evidation Health, Vector Institute for Artificial Intelligence, Cambridge Cognition Ltd, Bill and Melinda Gates Foundation
- Study start
- 4 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention Group (Exercisers) | Other | Behavioral: Lifestyle (Meditation)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. |
| Lifestyle Intervention Group (Meditators) | Other | Behavioral: Lifestyle (Exercise)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- Prior COVID-19 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Lifestyle Intervention Group (Exercisers) |
| 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. | Behavioural | Lifestyle Intervention Group (Meditators) |
Primary outcome
Study Retention
Time frame: 4 months
Proportion of participants completing the study
Daily survey/task adherence
Time frame: 4 months
Average completion of daily app-based surveys/tasks
Oura adherence
Time frame: 4 months
Average usage of the Oura smartring during study follow-up
Garmin adherence
Time frame: 4 months
Average usage of the Garmin smartwatch during study follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 26938265Bot 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.
- Background: PubMed 25289175Ghassemi 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.
- Background: PubMed 28815112Ghassemi 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.
- Background: PubMed 31372508Goodday 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.
- Derived from this study: PubMed 34726607Goodday 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Friend, PhD, MD principal investigator
4YouandMe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle (Meditation) and Lifestyle (Exercise) in people with Covid19 and Stress, run by 4YouandMe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Retention (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04713111, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.