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

  • STATUS
    Recruiting
  • End date
    Apr 27, 2040
  • participants needed
    20000
  • sponsor
    Villanova University
Updated on 19 February 2024
covid-19
SARS
acute respiratory syndrome (sars)

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.

Description

The objective of the US COVID-19 CHAMPS Study is to assess the short- and long-term physical, social and behavioral health of all who were involved in supporting or delivering care for COVID-19 patients. Included are first responders, maintenance and support staff as well as healthcare professionals of all specialties and services. Initially the study will obtain data on the working environment and emotional and physical health. Additional data will be obtained on self-management, response strategies, effects on family, social and personal life and careers. This well-characterized cohort of workers will enable characterization of the health and social effects of their service, and prospective research on their future physical and mental health. It will also serve as a registry for future, hypothesis-driven sub-studies of behavioral and biological coping mechanisms and allostatic load, as well as randomized clinical trials. Participants will be recruited throughout the United States and its territories (Puerto Rico, Guam, the US Virgin Islands) with outcomes followed longitudinally for twenty years.

Initial analysis will be descriptive and include computation of frequency distributions, adjusted odds ratios and 95% confidence intervals. Multiple logistic regression methods will be used to assess association of health symptoms or conditions with estimates of exposure to COVID-19. Psychological distress will be estimated from self-reported responses to validated psychological instruments and survey items created to capture the unique aspects of exposure to COVID-19 in workplace settings. Odds rations will be adjusted for sex, age, race/ethnicity and job classification. The logistic regression model(s) will include self-reported baseline health status and other variables. Preliminary explorations of variable associations will be performed to aid with the development of sub-studies from the registry.

No direct health benefits are anticipated for participating in the study, but participants may learn about their health. Participation in the study provides the participants the opportunity to express the impact of responding to the COVID-19 pandemic on their health, which may be a source of relief. Participants may feel satisfaction about sharing information about their experiences that may help healthcare systems to plan for future health-related emergencies.

Details
Condition Covid 19, Occupational Exposure to SARS-CoV-2
Age 18years - 100years
Clinical Study IdentifierNCT04370821
SponsorVillanova University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Anyone not meeting Inclusion Criteria
Clear my responses

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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