COVID-19 Pandemic Response Network

NCT ID: NCT04320862

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-03
• Study Completion Date: 2021-04-30

Brief Summary

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).

Conditions

COVID-19; SARS-CoV-2; Coronavirus; Influenza -Like Illness; Lower Resp Tract Infection; Upper Resp Tract Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Becky Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00105189

Identifier Type: -

Identifier Source: org_study_id