COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
COVID-19, SARS-CoV-2 Infection
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | Survey months 18, 24, 30, 36 | Measures level of disability on a scale from 0 - 14, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time. The score consists of 14 questions about activities of daily living. The I/ADL score is a sum total of reported limitations ranging from 0 (no limitations reported) to 14 (limitations in all activities asked reported). |
Countries
United States
Participant flow
Recruitment details
We retrospectively assembled 14 monthly cohorts of Veterans with a first positive test for COVID-19 and up to 20 matched uninfected comparators between March 2020 and April 2021. Survey participants were sampled from this parent cohort. First, we randomly sampled 100 Veterans with COVID-19 from each month between Oct 2020 and April 2021. Sampled Veterans were invited to participate in surveys. If a sampled Veteran consented, we reached out to five of their matched comparators to participate.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 235 |
| 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. | 244 |
| Total | 479 |
Baseline characteristics
| Characteristic | Total | Veterans Who Did Not Test Positive for COVID-19 (Comparator) | Veterans Who Tested Positive for COVID-19 (Case) |
|---|---|---|---|
| Age, Continuous | 61 years | 62 years | 61 years |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty bathing or showering? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty bathing or showering? Don't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty bathing or showering? No | 376 Participants | 191 Participants | 185 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty bathing or showering? Unknown | 6 Participants | 5 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty bathing or showering? Yes | 97 Participants | 48 Participants | 49 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty dressing, including putting on shoes and socks Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty dressing, including putting on shoes and socks Don't do | 15 Participants | 5 Participants | 10 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty dressing, including putting on shoes and socks No | 339 Participants | 178 Participants | 161 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty dressing, including putting on shoes and socks Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty dressing, including putting on shoes and socks Yes | 120 Participants | 57 Participants | 63 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty eating? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty eating? Don't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty eating? No | 443 Participants | 224 Participants | 219 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty eating? Unknown | 6 Participants | 4 Participants | 2 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty eating? Yes | 30 Participants | 16 Participants | 14 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty getting in or out of bed? Can't do | 1 Participants | 0 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty getting in or out of bed? Don't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty getting in or out of bed? No | 340 Participants | 172 Participants | 168 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty getting in or out of bed? Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty getting in or out of bed? Yes | 133 Participants | 68 Participants | 65 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty lifting over 10 pounds? Can't do | 5 Participants | 0 Participants | 5 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty lifting over 10 pounds? Don't do | 3 Participants | 2 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty lifting over 10 pounds? No | 273 Participants | 138 Participants | 135 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty lifting over 10 pounds? Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty lifting over 10 pounds? Yes | 193 Participants | 100 Participants | 93 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making medications? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making medications? Don't do | 5 Participants | 1 Participants | 4 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making medications? No | 396 Participants | 208 Participants | 188 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making medications? Unknown | 6 Participants | 5 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making medications? Yes | 72 Participants | 30 Participants | 42 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making phone calls? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making phone calls? Don't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making phone calls? No | 435 Participants | 226 Participants | 209 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making phone calls? Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty making phone calls? Yes | 39 Participants | 14 Participants | 25 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty managing money? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty managing money? Don't do | 11 Participants | 5 Participants | 6 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty managing money? No | 380 Participants | 200 Participants | 180 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty managing money? Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty managing money? Yes | 83 Participants | 35 Participants | 48 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty preparing a hot meal? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty preparing a hot meal? Don't do | 14 Participants | 5 Participants | 9 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty preparing a hot meal? No | 404 Participants | 203 Participants | 201 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty preparing a hot meal? Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty preparing a hot meal? Yes | 56 Participants | 32 Participants | 24 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty shopping for groceries? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty shopping for groceries? Don't do | 15 Participants | 5 Participants | 10 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty shopping for groceries? No | 339 Participants | 178 Participants | 161 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty shopping for groceries? Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty shopping for groceries? Yes | 120 Participants | 57 Participants | 63 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty stooping or kneeling? Can't do | 6 Participants | 3 Participants | 3 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty stooping or kneeling? Don't do | 2 Participants | 0 Participants | 2 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty stooping or kneeling? No | 144 Participants | 81 Participants | 63 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty stooping or kneeling? Unknown | 6 Participants | 5 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty stooping or kneeling? Yes | 321 Participants | 155 Participants | 166 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using map? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using map? Don't do | 6 Participants | 2 Participants | 4 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using map? No | 416 Participants | 217 Participants | 199 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using map? Unknown | 6 Participants | 4 Participants | 2 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using map? Yes | 51 Participants | 21 Participants | 30 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using toilet? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using toilet? Don't do | 1 Participants | 1 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using toilet? No | 380 Participants | 196 Participants | 184 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using toilet? Unknown | 6 Participants | 5 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty using toilet? Yes | 92 Participants | 42 Participants | 50 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty walking across room? Can't do | 0 Participants | 0 Participants | 0 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty walking across room? Don't do | 1 Participants | 0 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty walking across room? No | 348 Participants | 177 Participants | 171 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty walking across room? Unknown | 5 Participants | 4 Participants | 1 Participants |
| Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Difficulty walking across room? Yes | 125 Participants | 63 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 16 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 314 Participants | 127 Participants | 187 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 135 Participants | 101 Participants | 34 Participants |
| Race/Ethnicity, Customized Race Black | 84 Participants | 36 Participants | 48 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Unknown | 144 Participants | 106 Participants | 38 Participants |
| Race/Ethnicity, Customized Race White | 243 Participants | 98 Participants | 145 Participants |
| Region of Enrollment United States | 479 participants | 244 participants | 235 participants |
| Sex/Gender, Customized Sex Female | 43 Participants | 20 Participants | 23 Participants |
| Sex/Gender, Customized Sex Male | 307 Participants | 124 Participants | 183 Participants |
| Sex/Gender, Customized Sex Unknown | 129 Participants | 100 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 235 | 0 / 244 |
| other Total, other adverse events | 0 / 235 | 0 / 244 |
| serious Total, serious adverse events | 0 / 235 | 0 / 244 |
Outcome results
Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score
Measures level of disability on a scale from 0 - 14, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time. The score consists of 14 questions about activities of daily living. The I/ADL score is a sum total of reported limitations ranging from 0 (no limitations reported) to 14 (limitations in all activities asked reported).
Time frame: Survey months 18, 24, 30, 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Veterans Who Tested Positive for COVID-19 (Case) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 30-month I/ADL Score | 3.31 I/ADL Score | Standard Deviation 3.39 |
| Veterans Who Tested Positive for COVID-19 (Case) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 24-month I/ADL Score | 3.50 I/ADL Score | Standard Deviation 3.4 |
| Veterans Who Tested Positive for COVID-19 (Case) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 36-month I/ADL Score | 3.60 I/ADL Score | Standard Deviation 3.5 |
| Veterans Who Tested Positive for COVID-19 (Case) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 18-month I/ADL Score | 3.40 I/ADL Score | Standard Deviation 3.18 |
| Veterans Who Did Not Test Positive for COVID-19 (Comparator) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 36-month I/ADL Score | 3.30 I/ADL Score | Standard Deviation 3.2 |
| Veterans Who Did Not Test Positive for COVID-19 (Comparator) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 18-month I/ADL Score | 3.05 I/ADL Score | Standard Deviation 3.09 |
| Veterans Who Did Not Test Positive for COVID-19 (Comparator) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 24-month I/ADL Score | 3.40 I/ADL Score | Standard Deviation 3.3 |
| Veterans Who Did Not Test Positive for COVID-19 (Comparator) | Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score | 30-month I/ADL Score | 2.98 I/ADL Score | Standard Deviation 2.88 |