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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342806
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : October 27, 2022
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date April 8, 2020
First Posted Date April 13, 2020
Last Update Posted Date October 27, 2022
Actual Study Start Date April 10, 2020
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2021)
  • 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 ]
Original Primary Outcome Measures
 (submitted: April 10, 2020)
  • 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 supple information about their health to the HERO Registry at various time points after their enrollment [ Time Frame: Up to 79 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19
Official Title Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study
Brief 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 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.)
Condition
  • Health Care Worker (HCW)
  • COVID-19
Intervention Not Provided
Study Groups/Cohorts 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.)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 25, 2022)
51466
Original Estimated Enrollment
 (submitted: April 10, 2020)
100000
Actual Study Completion Date September 30, 2022
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04342806
Other Study ID Numbers Pro00105284
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor Duke University
Original Study Sponsor Same as current
Collaborators Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Emily O'Brien, PhD Duke University
PRS Account Duke University
Verification Date October 2022