COVID-19 InfectionCONSERVE-HCWNCT04595175
Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW)
An observational study of COVID-19 Infection, run by Brian Tiffany, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 30 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects that lack the ability for longitudinal follow-up; and/or
- Subjects that do not meet the above inclusion criteria. -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Chandler Regional Medical Center
Chandler, Arizona, 85224
Jennine Zumbuhl, RN, MSHA, 480-728-3674, jennine.zumbuhl@dignityhealth.org
Andrea Garcia, MBA, 602-406-9769, andrea.garcia2@dignityhealth.org
About this study
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.
Read the 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.
- Conditions
- COVID-19 Infection
- Keywords
- Serology, Wellness, SARS-CoV-2 IgG, Seroprevalence, Healthcare Workers
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline IgG Assay Information
Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs
Measured: Baseline
Change in IgG Assay Information
The change in the seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs over one year.
Measured: From Baseline to 3 months, 6 months, 9 months, & 12 months
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
Measured: From Baseline to 3 months, 6 months, 9 months, & 12 months
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start10 Jun 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Brian Tiffany, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Chandler Regional Medical Center, Arizona General Hospital, Mercy Gilbert Medical Center
- Responsible party
- Sponsor-investigator, Brian Tiffany, MD, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Brian Tiffany, MD, PhD, Principal investigator, Chief Medical Officer Dignity Health Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595175
- Sponsor's protocol ID
- 20-510-157-66-21
- Acronym
- CONSERVE-HCW
- Status last verified
- Oct 2020
- First submitted
- 10 Jun 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Seroprevalence and Wellness Over Time in Healthcare Workers (CONSERVE-HCW)
- ClinicalTrials.gov ID
- NCT04595175
- Acronym / sponsor ID
- CONSERVE-HCW / 20-510-157-66-21
- Conditions
- COVID-19 Infection
- Keywords
- Serology, Wellness, SARS-CoV-2 IgG, Seroprevalence, Healthcare Workers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Brian Tiffany, MDUniversity, hospital or other
- Collaborators
- Chandler Regional Medical Center, Arizona General Hospital, Mercy Gilbert Medical Center
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects that lack the ability for longitudinal follow-up; and/or
- Subjects that do not meet the above inclusion criteria. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline IgG Assay Information
Time frame: Baseline
Seroprevalence of anti-SARS-CoV-2 IgG antibodies in HCWs
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- COVID-19 Death tollLink provided by the sponsor.
- Healthcare worker COVID-19 infection ratesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Tiffany, MD, PhD principal investigator
Chief Medical Officer Dignity Health Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by Brian Tiffany, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea B. Garcia, MBA (602-406-9769, andrea.garcia2@dignityhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline IgG Assay Information (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.