Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04370821 |
| Other study ID # |
IRB FY2020-215 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 9, 2020 |
| Est. completion date |
June 5, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Villanova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
