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COVID-19 Citizen Science Expansion Project

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05548803
Recruitment Status : Enrolling by invitation
First Posted : September 21, 2022
Last Update Posted : October 4, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of California, San Francisco

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
Covid19

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.

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Study Type : Observational
Estimated Enrollment : 150000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : November 24, 2020
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Difficulty paying "for the very basics" [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Our goal will be to recruit a large sample of participants that is representative of the US population. In particular, we wish to make inferences about Hispanic/LatinX and African- American/Black subsets of the US population, who appear to be especially vulnerable to both direct (infection-related) and indirect impact of the Pandemic.
Criteria

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


Information from the National Library of Medicine

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): NCT05548803


Locations
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United States, California
Sutter Health
Sacramento, California, United States, 95833
University of California, San Francisco
San Francisco, California, United States, 94158
United States, Illinois
Advocate Aurora Health
Downers Grove, Illinois, United States, 60515
United States, Louisiana
Ochsner Health System
New Orleans, Louisiana, United States, 70121
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10467
NYC Health + Hospitals
New York, New York, United States, 10004
New York University
New York, New York, United States, 10016
United States, Texas
Baylor Scott and White Health
Dallas, Texas, United States, 95246
United States, Utah
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
Investigators
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Principal Investigator: Mark Pletcher, MD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05548803    
Other Study ID Numbers: 20203090
First Posted: September 21, 2022    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases