COVID-19 Pandemic Response Network
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04320862|
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 27, 2020
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).
|Condition or disease|
|COVID-19 SARS-CoV-2 Coronavirus Influenza -Like Illness Lower Resp Tract Infection Upper Resp Tract Infection|
|Study Type :||Observational|
|Estimated Enrollment :||200000 participants|
|Official Title:||Pandemic Response Network: Duke Community Health Watch|
|Actual Study Start Date :||April 3, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Duke Health region and beyond
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.
- Number of participants who experience inpatient admission [ Time Frame: 2 months ]
- Number of participants admitted to the intensive care unit [ Time Frame: 2 months ]
- Number of participants requiring mechanical ventilation [ Time Frame: 2 months ]
- Number of deceased participants [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320862
|Contact: Mark Sendak, MD, MPPemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27713|
|Sub-Investigator: Raquel Bartz, M.D.|
|Sub-Investigator: Manesh Patel, M.D.|
|Sub-Investigator: Devdutta Sangvai, M.D.|
|Sub-Investigator: Mark Sendak, M.D.|
|Principal Investigator:||Becky Smith, MD||Duke University|