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NCT Number: NCT04370821

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Villanova University

Villanova, Pennsylvania, 19085, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Two years

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

    Time frame: Two years

  3. Infectious disease and chronic disease incidence rates by demographic characteristics

    Time frame: Four years

  4. Completeness of data by demographic characteristics.

    Time frame: Two years

Secondary outcomes

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

    Time frame: four years

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

    Time frame: four years

Sponsors and collaborators

Lead sponsor

Villanova University

Other

Registry information

Acronym: CHAMPS

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 1, 2020
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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