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COVID-19 Observational Research Collaboratory

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05394025
Acronym
CORC LTO
Enrollment
479
Registered
2022-05-27
Start date
2022-05-18
Completion date
2024-06-01
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV-2 Infection

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

Johns Hopkins University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) ScoreSurvey months 18, 24, 30, 36Measures 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

ArmCount
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
Total479

Baseline characteristics

CharacteristicTotalVeterans Who Did Not Test Positive for COVID-19 (Comparator)Veterans Who Tested Positive for COVID-19 (Case)
Age, Continuous61 years62 years61 years
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering?
Don't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering?
No
376 Participants191 Participants185 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering?
Unknown
6 Participants5 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering?
Yes
97 Participants48 Participants49 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 Participants0 Participants0 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 Participants5 Participants10 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks
No
339 Participants178 Participants161 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks
Yes
120 Participants57 Participants63 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating?
Don't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating?
No
443 Participants224 Participants219 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating?
Unknown
6 Participants4 Participants2 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating?
Yes
30 Participants16 Participants14 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 Participants0 Participants1 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 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed?
No
340 Participants172 Participants168 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed?
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed?
Yes
133 Participants68 Participants65 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds?
Can't do
5 Participants0 Participants5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds?
Don't do
3 Participants2 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds?
No
273 Participants138 Participants135 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds?
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds?
Yes
193 Participants100 Participants93 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications?
Don't do
5 Participants1 Participants4 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications?
No
396 Participants208 Participants188 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications?
Unknown
6 Participants5 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications?
Yes
72 Participants30 Participants42 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls?
Don't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls?
No
435 Participants226 Participants209 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls?
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls?
Yes
39 Participants14 Participants25 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money?
Don't do
11 Participants5 Participants6 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money?
No
380 Participants200 Participants180 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money?
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money?
Yes
83 Participants35 Participants48 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal?
Don't do
14 Participants5 Participants9 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal?
No
404 Participants203 Participants201 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal?
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal?
Yes
56 Participants32 Participants24 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries?
Don't do
15 Participants5 Participants10 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries?
No
339 Participants178 Participants161 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries?
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries?
Yes
120 Participants57 Participants63 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling?
Can't do
6 Participants3 Participants3 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling?
Don't do
2 Participants0 Participants2 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling?
No
144 Participants81 Participants63 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling?
Unknown
6 Participants5 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling?
Yes
321 Participants155 Participants166 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map?
Don't do
6 Participants2 Participants4 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map?
No
416 Participants217 Participants199 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map?
Unknown
6 Participants4 Participants2 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map?
Yes
51 Participants21 Participants30 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet?
Don't do
1 Participants1 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet?
No
380 Participants196 Participants184 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet?
Unknown
6 Participants5 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet?
Yes
92 Participants42 Participants50 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room?
Can't do
0 Participants0 Participants0 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room?
Don't do
1 Participants0 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room?
No
348 Participants177 Participants171 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room?
Unknown
5 Participants4 Participants1 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room?
Yes
125 Participants63 Participants62 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
30 Participants16 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
314 Participants127 Participants187 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
135 Participants101 Participants34 Participants
Race/Ethnicity, Customized
Race
Black
84 Participants36 Participants48 Participants
Race/Ethnicity, Customized
Race
Other
8 Participants4 Participants4 Participants
Race/Ethnicity, Customized
Race
Unknown
144 Participants106 Participants38 Participants
Race/Ethnicity, Customized
Race
White
243 Participants98 Participants145 Participants
Region of Enrollment
United States
479 participants244 participants235 participants
Sex/Gender, Customized
Sex
Female
43 Participants20 Participants23 Participants
Sex/Gender, Customized
Sex
Male
307 Participants124 Participants183 Participants
Sex/Gender, Customized
Sex
Unknown
129 Participants100 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2350 / 244
other
Total, other adverse events
0 / 2350 / 244
serious
Total, serious adverse events
0 / 2350 / 244

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
Veterans Who Tested Positive for COVID-19 (Case)Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score30-month I/ADL Score3.31 I/ADL ScoreStandard Deviation 3.39
Veterans Who Tested Positive for COVID-19 (Case)Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score24-month I/ADL Score3.50 I/ADL ScoreStandard Deviation 3.4
Veterans Who Tested Positive for COVID-19 (Case)Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score36-month I/ADL Score3.60 I/ADL ScoreStandard Deviation 3.5
Veterans Who Tested Positive for COVID-19 (Case)Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score18-month I/ADL Score3.40 I/ADL ScoreStandard 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) Score36-month I/ADL Score3.30 I/ADL ScoreStandard 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) Score18-month I/ADL Score3.05 I/ADL ScoreStandard 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) Score24-month I/ADL Score3.40 I/ADL ScoreStandard 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) Score30-month I/ADL Score2.98 I/ADL ScoreStandard Deviation 2.88
Comparison: Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.p-value: 0.7795% CI: [-0.13, 0.18]likelihood ratio test
Comparison: Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model I/ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.p-value: 0.695% CI: [-0.44, 0.67]likelihood ratio test

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026