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

• Conditions: COVID-19 Infection

• Registration Number: NCT04595175
• Lead Sponsor: Brian Tiffany, MD

Brief Summary

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.

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 Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2020-06-10
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-19
• Last Update Submitted: 2020-10-19
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline IgG Assay Information	Baseline	Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs
Change in IgG Assay Information	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.
Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies between groups	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
Impact of COVID-19 Pandemic on Perceived Wellness and Job Satisfaction	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.

Trial Locations

Locations (1)

Chandler Regional Medical Center; 🇺🇸 Chandler, Arizona, United States