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

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ClinicalTrials.gov Identifier: NCT04595175
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborators:
Chandler Regional Medical Center
Arizona General Hospital
Mercy Gilbert Medical Center
Information provided by (Responsible Party):
Brian Tiffany, MD, St. Joseph's Hospital and Medical Center, Phoenix

Study Description
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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
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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW)
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Baseline IgG Assay Information [ Time Frame: Baseline ]
    Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs

  2. 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.

  3. 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

  4. 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.


Biospecimen Retention:   Samples Without DNA
One tube of blood will be sent to the appropriate hospital lab for the Abbott IgG testing. The other two tubes of blood will be processed and biobanked. The same tubes will be drawn on the subsequent visits.

Eligibility Criteria
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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
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.
Criteria

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. -
Contacts and Locations
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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): NCT04595175


Contacts
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Contact: Andrea B. Garcia, MBA 602-406-9769 andrea.garcia2@dignityhealth.org
Contact: Jennine Zumbuhl, RN, MSHA 480-728-3674 jennine.zumbuhl@dignityhealth.org

Locations
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United States, Arizona
Chandler Regional Medical Center Recruiting
Chandler, Arizona, United States, 85224
Contact: Jennine Zumbuhl, RN, MSHA    480-728-3674    jennine.zumbuhl@dignityhealth.org   
Contact: Andrea Garcia, MBA    602-406-9769    andrea.garcia2@dignityhealth.org   
Sponsors and Collaborators
Brian Tiffany, MD
Chandler Regional Medical Center
Arizona General Hospital
Mercy Gilbert Medical Center
Investigators
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Principal Investigator: Brian Tiffany, MD, PhD Chief Medical Officer Dignity Health Arizona
More Information
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Additional Information:

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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: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Tiffany, MD, St. Joseph's Hospital and Medical Center, Phoenix:
Serology
Wellness
SARS-CoV-2 IgG
Seroprevalence
Healthcare Workers
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