Health Care Worker (HCW)NCT04342806
Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19
An observational study of Health Care Worker (HCW) and COVID-19, run by Duke University at 1 site in United States.
Trial summary
The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their families and communities. The overall goal of the Registry is to develop the infrastructure necessary to create and engage a community of people who may be eligible for… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Health Care Worker (HCW), COVID-19
- How many people
- 51,466 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2020to 30 Sep 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 to 110 years
- All sexes
- Adult, Older adult
Study population: The HERO Registry will include HCWs currently working across the United States, and their families and communities. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare. (Note: individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as housekeeping, food service, etc.)
Who may be able to join
- A member of one of the following three groups:
- Individual currently works in a setting where individuals receive healthcare ("healthcare worker") (including emergency medical services), OR
- A family member of a healthcare worker, OR
- A member of a healthcare worker's community
- Age ≥ 18
- Able to speak and read English or Spanish
Who cannot join
- There are no specific exclusion criteria for this study. Participants must meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27701
About this study
Official title: Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study
The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their families and communities. The overall goal of the Registry is to develop the infrastructure necessary to create and engage a community of people who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment.
Read the detailed description
The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their family members and communities. The overall goal of the Registry is to create and engage a community of HCWs and their families and communities who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment. The HERO registry will create a repository of adults interested in COVID-19 research that can be eligible for future research studies. The main objectives of the study are 1) create a virtual community of adult HCWs in the United States, and their families and communities, 2) Identify adults interested in engaging in upcoming research studies, including those related to COVID-19, and 3) Create a dataset of health related measurements, risk factors, and outcomes for future analysis. The population of interest is adult healthcare workers in the United States, and their families and communities.
All analysis of the HERO Registry will be exploratory in nature. Analysis may include descriptive statistics of the cohort, statistical associations between variables of interest, and predictive modeling for health outcomes and behaviors. Analyses may be conducted on all participants in the HERO Registry or may be conducted on subpopulations defined based on clinical, demographic or other factors.
There is no direct benefit to the participants for their participation in this study, but the information obtained will be used in scientific research and may be helpful to the participant or others in the future. Participants may experience indirect benefits such as learning about their own health, access to health data, and opportunities to participate in future research.
- Conditions
- Health Care Worker (HCW), COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCWs currently working in the US, and their families and communities | The HERO Registry will include HCWs currently working across the United States, and their families and communities. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare. (Note: individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as housekeeping, food service, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percent of participants who enroll in the HERO Registry Study by geographic region, age, COVID-19 risk factors, and past COVID-19 diagnosis
Measured: Up to 79 years
Distribution of COVID-19 risk factors by participant characteristics
Measured: Up to 79 years
Proportion of participants undergoing changes in health status (e.g. new diagnosis of COVID-19, ER visits, hospitalization)
Measured: Up to 79 years
Proportion of all participants enrolled in the HERO Registry who participate in an ancillary research study
Measured: Up to 79 years
Proportion of participants who continue to supply information about their health to the HERO Registry at various time points after their enrollment
Measured: Up to 79 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start10 Apr 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health Care Worker (HCW)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51,466 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Emily O'Brien, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342806
- Sponsor's protocol ID
- Pro00105284
- Status last verified
- Aug 2023
- First submitted
- 8 Apr 2020
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lusk JB, Manandhar P, Thomas LE, O'Brien EC. Association between characteristics of employing healthcare facilities and healthcare worker infection rates and psychosocial experiences during the COVID-19 pandemic. BMC Health Serv Res. 2024 May 24;24(1):659. doi: 10.1186/s12913-024-11109-6.
PubMed 38783301Apple R, O'Brien EC, Daraiseh NM, Xu H, Rothman RL, Linzer M, Thomas L, Roumie C. Gender and intention to leave healthcare during the COVID-19 pandemic among U.S. healthcare workers: A cross sectional analysis of the HERO registry. PLoS One. 2023 Jun 16;18(6):e0287428. doi: 10.1371/journal.pone.0287428. eCollection 2023.
PubMed 37327216Chen-Lim ML, McCabe MA, Xu H, Thomas LE, Forrest CB, Birnbaum S, Webb LE, O'Brien EC. Experiences of U.S. Nurses Compared With Nonnurses in the First Year of COVID-19: Findings From a National Registry. Nurs Res. 2022 Nov-Dec 01;71(6):421-431. doi: 10.1097/NNR.0000000000000610. Epub 2022 Jul 23.
PubMed 35878076Forrest CB, Xu H, Thomas LE, Webb LE, Cohen LW, Carey TS, Chuang CH, Daraiseh NM, Kaushal R, McClay JC, Modave F, Nauman E, Todd JV, Wallia A, Bruno C, Hernandez AF, O'Brien EC; HERO Registry Research Group. Impact of the Early Phase of the COVID-19 Pandemic on US Healthcare Workers: Results from the HERO Registry. J Gen Intern Med. 2021 May;36(5):1319-1326. doi: 10.1007/s11606-020-06529-z. Epub 2021 Mar 10.
PubMed 33694071
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study
- ClinicalTrials.gov ID
- NCT04342806
- Acronym / sponsor ID
- Pro00105284
- Conditions
- Health Care Worker (HCW), COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51,466 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 13 Apr 2020 (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 HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their families and communities. The overall goal of the Registry is to develop the infrastructure necessary to create and engage a community of people who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment.
Detailed description
The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their family members and communities. The overall goal of the Registry is to create and engage a community of HCWs and their families and communities who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment. The HERO registry will create a repository of adults interested in COVID-19 research that can be eligible for future research studies. The main objectives of the study are 1) create a virtual community of adult HCWs in the United States, and their families and communities, 2) Identify adults interested in engaging in upcoming research studies, including those related to COVID-19, and 3) Create a dataset of health related measurements, risk factors, and outcomes for future analysis. The population of interest is adult healthcare workers in the United States, and their families and communities.
All analysis of the HERO Registry will be exploratory in nature. Analysis may include descriptive statistics of the cohort, statistical associations between variables of interest, and predictive modeling for health outcomes and behaviors. Analyses may be conducted on all participants in the HERO Registry or may be conducted on subpopulations defined based on clinical, demographic or other factors.
There is no direct benefit to the participants for their participation in this study, but the information obtained will be used in scientific research and may be helpful to the participant or others in the future. Participants may experience indirect benefits such as learning about their own health, access to health data, and opportunities to participate in future research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCWs currently working in the US, and their families and communities | – | –The HERO Registry will include HCWs currently working across the United States, and their families and communities. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare. (Note: individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as housekeeping, food service, etc.) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The HERO Registry will include HCWs currently working across the United States, and their families and communities. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare. (Note: individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as housekeeping, food service, etc.)
Key inclusion criteria (6 listed)
- A member of one of the following three groups:
- Age ≥ 18
- Able to speak and read English or Spanish
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study. Participants must meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and percent of participants who enroll in the HERO Registry Study by geographic region, age, COVID-19 risk factors, and past COVID-19 diagnosis
Time frame: Up to 79 years
Distribution of COVID-19 risk factors by participant characteristics
Time frame: Up to 79 years
Proportion of participants undergoing changes in health status (e.g. new diagnosis of COVID-19, ER visits, hospitalization)
Time frame: Up to 79 years
Proportion of all participants enrolled in the HERO Registry who participate in an ancillary research study
Time frame: Up to 79 years
Proportion of participants who continue to supply information about their health to the HERO Registry at various time points after their enrollment
Time frame: Up to 79 years
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 5 Sep 2023.
- Derived from this study: PubMed 38783301Lusk JB, Manandhar P, Thomas LE, O'Brien EC. Association between characteristics of employing healthcare facilities and healthcare worker infection rates and psychosocial experiences during the COVID-19 pandemic. BMC Health Serv Res. 2024 May 24;24(1):659. doi: 10.1186/s12913-024-11109-6.
- Derived from this study: PubMed 37327216Apple R, O'Brien EC, Daraiseh NM, Xu H, Rothman RL, Linzer M, Thomas L, Roumie C. Gender and intention to leave healthcare during the COVID-19 pandemic among U.S. healthcare workers: A cross sectional analysis of the HERO registry. PLoS One. 2023 Jun 16;18(6):e0287428. doi: 10.1371/journal.pone.0287428. eCollection 2023.
- Derived from this study: PubMed 35878076Chen-Lim ML, McCabe MA, Xu H, Thomas LE, Forrest CB, Birnbaum S, Webb LE, O'Brien EC. Experiences of U.S. Nurses Compared With Nonnurses in the First Year of COVID-19: Findings From a National Registry. Nurs Res. 2022 Nov-Dec 01;71(6):421-431. doi: 10.1097/NNR.0000000000000610. Epub 2022 Jul 23.
- Derived from this study: PubMed 33694071Forrest CB, Xu H, Thomas LE, Webb LE, Cohen LW, Carey TS, Chuang CH, Daraiseh NM, Kaushal R, McClay JC, Modave F, Nauman E, Todd JV, Wallia A, Bruno C, Hernandez AF, O'Brien EC; HERO Registry Research Group. Impact of the Early Phase of the COVID-19 Pandemic on US Healthcare Workers: Results from the HERO Registry. J Gen Intern Med. 2021 May;36(5):1319-1326. doi: 10.1007/s11606-020-06529-z. Epub 2021 Mar 10.
- Impact of the Early Phase of the COVID-19 Pandemic on US Healthcare Workers: Results from the HERO RegistryLink provided by the sponsor.
- Racial/Ethnic Disparities in Healthcare Worker Experiences During the COVID-19 Pandemic: An Analysis of the HERO RegistryLink provided by the sponsor.
- Patterns of Potential Moral Injury in Post-9/11 Combat Veterans and COVID-19 Healthcare WorkersLink provided by the sponsor.
- Gender and intention to leave healthcare during the COVID-19 pandemic among U.S. healthcare workers: A cross sectional analysis of the HERO registryLink provided by the sponsor.
- Experiences of U.S. Nurses Compared With Nonnurses in the First Year of COVID-19: Findings From a National RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Emily O'Brien, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Worker (HCW) and COVID-19, run by Duke University 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 5 Sep 2023. 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?
Number and percent of participants who enroll in the HERO Registry Study by geographic region, age, COVID-19 risk factors, and past COVID-19 diagnosis (time frame: Up to 79 years). The study lists 5 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 NCT04342806, which also lists 4 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 5 Sep 2023.