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临床试验/NCT04370821
NCT04370821进行中(未招募)不适用

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

Villanova University1 个研究点 分布在 1 个国家目标入组 2,600 人开始时间: 2020年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,600
试验地点
1
主要终点
Sample Size of enrolled CHAMPS Study participants by demographic characteristics during the first two years of the study

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Anyone not meeting Inclusion Criteria.

结局指标

主要结局

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

时间窗: Two years

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

时间窗: Two years

Infectious disease and chronic disease incidence rates by demographic characteristics

时间窗: Four years

Completeness of data by demographic characteristics.

时间窗: Two years

次要结局

  • Number of participants enrolled in randomized trials based on the CHAMPS registry(four years)
  • Participation rates in ancillary and sub-studies within the CHAMPS registry.(four years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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