Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW) (CONSERVE-HCW)

October 19, 2020 updated by: Brian Tiffany, MD
The Investigators propose a multi-center, observational, longitudinal, cohort study of the serology and wellness of HCWs over a year of the COVID-19 pandemic.

Study Overview

Status

Unknown

Conditions

Detailed Description

All consenting participants will undergo survey assessment and diagnostic testing with the Abbott Architect SARS-CoV-2 IgG assay (IgG) every three months for a one year period. Clinical outcomes and related data capture will be performed at this same interval.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants will be enrolled across CommonSpirit Health hospitals and care facilities (all branded as Dignity Health) at five sites in Maricopa County, Arizona: Arizona General Hospital, Chandler Regional Medical Center, Mercy Gilbert Medical Center, St. Joseph's Hospital and Medical Center and St. Joseph's Westgate Medical Center.

Description

Inclusion Criteria:

  1. Age greater than or equal to 18 years; and
  2. Be an active member of the CommonSpirit Health workforce or medical staff during the COVID-19 pandemic and at the time of enrollment; and
  3. Have access to the Internet; and
  4. The ability to provide informed consent.

Exclusion Criteria:

  1. Subjects that lack the ability for longitudinal follow-up; and/or
  2. Subjects that do not meet the above inclusion criteria. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline IgG Assay Information
Time Frame: Baseline
Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs
Baseline
Change in IgG Assay Information
Time Frame: From Baseline to 3 months, 6 months, 9 months, & 12 months
The change in the seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs over one year.
From Baseline to 3 months, 6 months, 9 months, & 12 months
Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies between groups
Time Frame: From Baseline to 3 months, 6 months, 9 months, & 12 months
Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies in 'front-line' workers and non-'front-line' HCWs
From Baseline to 3 months, 6 months, 9 months, & 12 months
Impact of COVID-19 Pandemic on Perceived Wellness and Job Satisfaction
Time Frame: Baseline to 12 months
Over the 12 months of the study, evaluate the impact of the COVID-19 pandemic on HCW wellness using the Perceived Wellness Survey. Job satisfaction will be measured using a locally developed questionnaire.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brian Tiffany, MD

Collaborators

Chandler Regional Medical Center
Mercy Gilbert Medical Center
Arizona General Hospital

Investigators

  • Principal Investigator: Brian Tiffany, MD, PhD, Chief Medical Officer Dignity Health Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-510-157-66-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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