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临床试验/NCT04320862
NCT04320862已完成不适用

Pandemic Response Network: Duke Community Health Watch

Duke University1 个研究点 分布在 1 个国家目标入组 9,207 人开始时间: 2020年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9,207
试验地点
1
主要终点
Number of participants who experience inpatient admission

研究概览

简要总结

Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives.

  • First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll.
  • Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation.
  • Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population.

The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • flu-like symptoms
  • a viral test order for COVID-19
  • confirmed COVID-19
  • concern for exposure to COVID-19

排除标准

  • 未提供

结局指标

主要结局

Number of participants who experience inpatient admission

时间窗: 2 months

次要结局

  • Number of participants requiring mechanical ventilation(2 months)
  • Number of deceased participants(2 months)
  • Number of participants admitted to the intensive care unit(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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