COVID-19 CHAMPS Study of Healthcare, First Responder and Service Workers

NCT04370821 | Active Not Recruiting

• 1 other identifier: IRB FY2020-215
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 CHAMPS Study will obtain data on the physical and mental health and well-being of workers potentially exposed to the SARS-CoV-2 virus in the course of their duties. Included are a broad range of occupations including those working in the community (police officers, firefighters, emergency personnel, screening staff) as well as in permanent or temporary sites that care for patients (service staff, nurses, physicians and other health professionals). CHAMPS will obtain data on various exposure factors and health and create a registry of participants for extended follow up and sub-studies.

Conditions

Occupational Exposure to SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (4)

• Sample Size of enrolled CHAMPS Study participants by demographic characteristics during the first two years of the study

  Two years

• Exposure to SARS-CoV-2 based on models computed from participant baseline data and community variables, if available.

  Two years

• Infectious disease and chronic disease incidence rates by demographic characteristics

  Four years

• Completeness of data by demographic characteristics.

  Two years

Secondary Outcomes (2)

• Participation rates in ancillary and sub-studies within the CHAMPS registry.

  four years

• Number of participants enrolled in randomized trials based on the CHAMPS registry

  four years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult exposed to increased risk of infection by SARS-CoV-2 as a result of work in the community or in settings where COVID-19 patients are screened, diagnosed or receive care. Included are first responders (e.g., police officers, firefighters, emergency medical technicians, paramedics) service employees (office staff, maintenance, housekeeping, food service), and healthcare professionals (e.g., physicians, nurses, phlebotomists, respiratory therapists, pharmacists).

You may qualify if:

• Age 18 years or older
• Working in a facility that screens, diagnoses, or treats COVID-19 patients or in the community as a first responder.
• Able to read and speak English

Sponsors & Collaborators

• Villanova University: lead

Study Sites (1)

Villanova University

Villanova, Pennsylvania, 19085, United States

Location

Related Publications (1)

• Kaufmann PG, Havens DS, Mensinger JL, Bradley PK, Brom HM, Copel LC, Costello A, D'Annunzio C, Dean Durning J, Maldonado L, Barrow McKenzie A, Smeltzer SC, Yost J; CHAMPS Study Investigators. The COVID-19 Study of Healthcare and Support Personnel (CHAMPS): Protocol for a Longitudinal Observational Study. JMIR Res Protoc. 2021 Oct 7;10(10):e30757. doi: 10.2196/30757.

  PMID: 34582354 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Heather Brom, PhD

  Villanova University

  PRINCIPAL INVESTIGATOR

• Donna Havens, PhD,RN,FAAN

  Villanova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 1, 2020
• Study Start: May 9, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)