Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19

August 30, 2023 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

51466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

* There are no specific exclusion criteria for this study. Participants must meet inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 79 years
Distribution of COVID-19 risk factors by participant characteristics
Time Frame: Up to 79 years
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
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
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
Up to 79 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Emily O'Brien, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00105284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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