COVID-19 Observational Research Collaboratory (CORC LTO)

February 26, 2024 updated by: VA Office of Research and Development

COVID-19 Observational Research Collaboratory - Long-Term Outcomes (LTO) Study

This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2 using electronic health record information and structured surveys.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Background: Early evidence suggests that the frequency and type of long term complications stemming from SARS-CoV-2 infection may depend on the severity of initial presentation. However, additional unidentified factors may also play a role including those related to the individual, the environment and/or the specific strain of the virus. The long-term health impacts of SARS-CoV-2 will have major implications for health care utilization, care processes and quality and costs of care for Veterans, both within the VA and in the community. Over 200,000 Veterans have had COVID-19. Although the long term consequences of this novel illness are unknown, it is clear they will often be significant. The overarching goal in the Long-Term Outcome Study (LTO) is to advance VA HSR&D research into the consequences and care of COVID-19 infection by developing and releasing integrated multi-modal data and results on long-term outcomes of COVID for use by VA clinical, research and operations communities. The investigators will do so via a coordinated program of data production and analysis using the VA electronic health record (EHR) and other administrative sources (e.g., Medicare), de novo longitudinal survey, and qualitative inquiry. This work will be closely coordinated with the COVID-19 Observational Research Collaboratory (CORC) Coordinating Center (CCC) and the burgeoning community of HSR&D-funded COVID researchers.

This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2.

Aim 1: Using VINCI-CDW data, patients will be identified who had a SARS-CoV-2 test since February 2020. The investigators will use a combination of traditional epidemiologic studies, and machine learning algorithms to determine the long term, multi-systemic and functional adverse outcomes and/or syndromes related to SARS-CoV-2. Members of the research team are currently developing methods to identify new onset and exacerbations in comorbidities following SARS-CoV-2 illness in Veterans.

Aim 2: Determine Veteran-Reported Outcome Effects Using Structured Survey on domains such as self- reported symptoms, disability, and financial impacts, measured repeatedly over 36 months.

Study Type

Observational

Enrollment (Estimated)

3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Michigan
      • Ann Arbor, Michigan, United States, 48105-2303
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Durham VA Medical Center, Durham, NC
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • VA Portland Health Care System, Portland, OR
    • Utah
      • Salt Lake City, Utah, United States, 84148-0001
        • VA Salt Lake City Health Care System, Salt Lake City, UT
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All VA enrollees since February 2020, which includes all patients who were tested for SARS-CoV-2 and are included in the VA COVID-19 Shared Data Resource in CDW.

Description

Inclusion Criteria:

All VA enrollees since February 2020, which includes all patients who were tested for SARS-CoV-2 and are included in the VA COVID-19 Shared Data Resource in CDW.

Exclusion Criteria:

VA employees

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Veterans who tested positive for COVID-19 (case)
The investigators will organize the sampling of cases (and later of comparators) around the waves of the epidemic, as defined by their nadirs between national death rates-each approximately 3-4 months long. The investigators will initiate surveys of Veterans who have survived their initial SARS-CoV-2 infection. The viral infection "index date" will be defined as date of each patient's first positive test.
Veterans who did not test positive for COVID-19 (comparator)
To support causal inference, the investigators will also sample Veterans without COVID who are matched to participants with COVID-19. In general, cases will be compared to comparators matched on risk of developing COVID infection during a given wave.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of Daily Living Scale (ADL) Change
Time Frame: Survey months 12, 18, 24, 30, 36
Measures level of disability on a scale from 0 - 6, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time.
Survey months 12, 18, 24, 30, 36
Instrumental Activities of Daily Living (IADL) Change
Time Frame: Survey months 12, 18, 24, 30, 36
Measures level of disability on a scale from 0 - 8, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time.
Survey months 12, 18, 24, 30, 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Ann M. O'Hare, MD MA, VA Puget Sound Health Care System Seattle Division, Seattle, WA
  • Principal Investigator: Christopher Barrett Bowling, MD BS, Durham VA Medical Center, Durham, NC
  • Principal Investigator: Elizabeth M Viglianti, MD MPH MSc, VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Principal Investigator: Amy S Bohnert, PhD MHS BA, VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Principal Investigator: Denise M. Hynes, PhD MPH RN, VA Portland Health Care System, Portland, OR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C19 21-279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Beginning six months after the first survey is collected, updated releases of all structured survey items and basic summary scores will be released via VINCI for all VA investigators with appropriate permissions-but specific HIPAA-protected identifiers will not be included. The research information sheet and recruitment letter include the VA's recommended explicit language about this and the option to opt out.

IPD Sharing Time Frame

Releases of survey items and scores will occur every six months and will be available indefinitely

IPD Sharing Access Criteria

Researchers that access this data for future research use may be national or international and affiliated or unaffiliated with the VA, and may only use the data for research purposes. Future studies will have appropriate data use agreements in place as well as receive approval by an IRB and other oversight committees prior to starting any research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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