COVID-19 Citizen Science Expansion Project

University of California, San Francisco (Other)
Overall Status
Enrolling by invitation ID
Sutter Health (Other), HealthCore-NERI (Other), Louisiana Public Health Institute (Other), Duke University (Other), New York University (Other), Albert Einstein College of Medicine (Other), University of Utah (Other), Ochsner Health System (Other), Baylor Scott and White Health (Other), Advocate Aurora Health (Other), NYC Health + Hospitals (Other)

Study Details

Study Description

Brief Summary

COVID-19 Citizen Science (CCS), launched in March 2020, supports collaborative research on symptoms, risk factors, surveillance, biomarkers and testing for COVID-19 using the Eureka Research Platform. CCS maintains IRB approval with UCSF's IRB (UCSF IRB# 17-21879).

This CCS Expansion Project, which is funded jointly by the National Institutes of Health (NIH), the Patient-Centered Outcomes Research Institute (PCORI), and the Bill and Melinda Gates Foundation, will invite patients at health systems across the US to contribute their health records data and then join the established CCS study, allows for linked analysis of CCS data and health records data, and provides the scientific rationale and plan for the project.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Shelter-in-place orders, social distancing, and mandatory closure of non-essential businesses across the country have suppressed transmission of SARS-CoV-2 and limited direct health impact of the COVID-19 Pandemic. These policies, however, exact an enormous societal cost and cannot be maintained indefinitely. When and how to lift restrictions represents the defining challenge of our time for local, state and national leaders, and requires excruciating decisions that balance lives lost from coronavirus infection against economic, social and indirect health effects of restrictive policy. To understand the impact of these decisions, we must hear from patients. We propose to recruit a large population-based sample of PCORnet patients into our digital cohort of "COVID-19 Citizen Scientists," gather patient-reported outcomes with linked electronic health record (EHR), and analyze it to answer the following critical research questions (RQs):

    RQ1: What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients? The natural experiment that occurs as state governors and local county health departments across the US differentially lift and/or reinstate shelter-in-place policies, and that is ongoing today as the US considers reopening fully (despite threats from new coronavirus variants), represents an analytic opportunity to estimate and compare benefits and harms of different policies, both overall and for vulnerable subsets of the population. To leverage this opportunity, we will collect a detailed record of county- (and state-) level COVID-19-related policies, including shelter-in-place (aka containment & closure), economic response and public health policies, starting at the beginning of the Pandemic in March 2020 and continuing through the end of the year into 2021. We have selected 119 counties for data collection where we have the most patient-reported survey responses through 2020, and where we expect to enroll many new participants through Fall 2021. We will use these data to analyze the impact on patient-reported outcomes, and then make them available to other investigators.

    RQ2: What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to COVID-19 vaccination (overall and among previously hesitant persons), testing, healthcare, information, and contact tracing, overall and in vulnerable populations? Timely access to containment and mitigation strategies were (and will continue to be) critical to quickly detect and slow transmission of coronavirus and future pandemics in communities, and to effectively care for patients who become infected. Unlike shelter-in-place policies that are highly publicized, containment and mitigation strategies are about resource allocation and operational effectiveness. Decision-making may be hidden, but we can measure the effectiveness of these strategies by asking patients. For example, we can assess reasons for vaccination among participants that were previously hesitant, delays in coronavirus testing after patients develop symptoms using our daily symptom survey data to provide the denominator (all symptomatic patients) and the anchor time point (time of symptom onset); and weekly surveys will assess access to critical information (e.g., "Do you know how to get a COVID-19 test?") and contact tracing after testing positive.

    Study Design

    Study Type:
    Anticipated Enrollment :
    150000 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Comparing Patient-reported Impact of COVID-19 Shelter-in-place Policies and Access to Containment and Mitigation Strategies, Overall and in Vulnerable Populations
    Actual Study Start Date :
    Nov 24, 2020
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Difficulty paying "for the very basics" [Over the course of the pandemic, up to 5 years]

      This outcome is assessed by asking the following question monthly: "How hard is it for you (and your family) to pay for the very basics like food, rent or mortgage, heating, etc over the past 30 days?" Possible scores range from 1 (very hard) to 4 (not very hard), "Don't know" and "Prefer not to state."

    2. Time-to-testing if symptomatic [Over the course of the pandemic, up to 5 years]

      Time-to-testing, measured by number of days, will be calculated by subtracting COVID-19 testing date from date of symptom onset.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    1. Age ≥ 18 years

    2. Has the capacity to read and comprehend English

    3. Has internet access and a device (computer, tablet, laptop, etc.) that can access it

    Exclusion Criteria:
    1. Unable or unwilling to provide informed consent

    Contacts and Locations


    Site City State Country Postal Code
    1 Sutter Health Sacramento California United States 95833
    2 University of California, San Francisco San Francisco California United States 94158
    3 Advocate Aurora Health Downers Grove Illinois United States 60515
    4 Ochsner Health System New Orleans Louisiana United States 70121
    5 Albert Einstein College of Medicine Bronx New York United States 10467
    6 NYC Health + Hospitals New York New York United States 10004
    7 New York University New York New York United States 10016
    8 Baylor Scott and White Health Dallas Texas United States 95246
    9 University of Utah Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • University of California, San Francisco
    • Sutter Health
    • HealthCore-NERI
    • Louisiana Public Health Institute
    • Duke University
    • New York University
    • Albert Einstein College of Medicine
    • University of Utah
    • Ochsner Health System
    • Baylor Scott and White Health
    • Advocate Aurora Health
    • NYC Health + Hospitals


    • Principal Investigator: Mark Pletcher, MD, MPH, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    University of California, San Francisco Identifier:
    Other Study ID Numbers:
    • 20203090
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2022