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

Sponsor

Brian Tiffany, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT04595175

Collaborator

Chandler Regional Medical Center (Other), Arizona General Hospital (Other), Mercy Gilbert Medical Center (Other)

2,000

Enrollment

Location

18.7

Anticipated Duration (Months)

107.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infection

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 10, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chandler Regional Medical Center	Chandler	Arizona	United States	85224

Sponsors and Collaborators

Brian Tiffany, MD
Chandler Regional Medical Center
Arizona General Hospital
Mercy Gilbert Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Brian Tiffany, MD, Chief Medical Officer, St. Joseph's Hospital and Medical Center, Phoenix

ClinicalTrials.gov Identifier:

NCT04595175

Other Study ID Numbers:

20-510-157-66-21

First Posted:

Oct 20, 2020

Last Update Posted:

Oct 20, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Brian Tiffany, MD, Chief Medical Officer, St. Joseph's Hospital and Medical Center, Phoenix

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 20, 2020