COVID-19 Pandemic Response Network

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04320862
Collaborator
(none)
9,207
1
12.9
714.9

Study Details

Study Description

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).

Study Design

Study Type:
Observational
Actual Enrollment :
9207 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pandemic Response Network: Duke Community Health Watch
Actual Study Start Date :
Apr 3, 2020
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants who experience inpatient admission [2 months]

Secondary Outcome Measures

  1. Number of participants admitted to the intensive care unit [2 months]

  2. Number of participants requiring mechanical ventilation [2 months]

  3. Number of deceased participants [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • flu-like symptoms

  • a viral test order for COVID-19

  • confirmed COVID-19

  • concern for exposure to COVID-19

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27713

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Becky Smith, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04320862
Other Study ID Numbers:
  • Pro00105189
First Posted:
Mar 25, 2020
Last Update Posted:
Sep 17, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2021