COVID-19 Observational Research Collaboratory
- Conditions
- COVID-19SARS-CoV-2 Infection
- Registration Number
- NCT05394025
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 731
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.
VA employees
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score Change Survey months 18, 24, 30, 36 Measures level of disability on a scale from 0 - 13, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Durham VA Medical Center, Durham, NC
🇺🇸Durham, North Carolina, United States
VA Portland Health Care System, Portland, OR
🇺🇸Portland, Oregon, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
🇺🇸Ann Arbor, Michigan, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
🇺🇸Salt Lake City, Utah, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
🇺🇸Seattle, Washington, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
🇺🇸West Haven, Connecticut, United States