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

COVID-19 Infection Clinical Trial

— CONSERVE-HCW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595175
• Other study ID #: 20-510-157-66-21
• Status: Recruiting
• Start date: June 10, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2020
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: Andrea B. Garcia, MBA
• Phone: 602-406-9769
• Email: andrea.garcia2[@]dignityhealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• COVID-19 Infection

Locations

Country	Name	City	State
United States	Chandler Regional Medical Center	Chandler	Arizona

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline IgG Assay Information	Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs	Baseline
Primary	Change in IgG Assay Information	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
Primary	Compare seroprevalence of anti-SARS-CoV-2 IgG antibodies between groups	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
Primary	Impact of COVID-19 Pandemic on Perceived Wellness and Job Satisfaction	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

External Links

•   COVID-19 Death toll
•   Healthcare worker COVID-19 infection rates