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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RX003666-01 | U.S. NIH Grant/Contract | View source |
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This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.
The long-term consequences of COVID 19 are not well understood, particularly in the Veteran population. This study will describe and quantify the long-term consequences of COVID-19, including impairment in physical and psychosocial function and health-related quality of life. Additionally, it will determine the impact of chronic lung disease (CLD) and other comorbidities on severity and recovery after COVID-19 infection and the association of social determinants of health with severity and recovery.
Initially, a retrospective national cohort of VA patients who test positive with SARS2 will be identified. Baseline clinical history will be analyzed with outcomes that include severity of COVID 19, all-cause mortality, and post-discharge events.
Subsequently, a mixed methods, prospective cohort study will include both qualitative (interview) and quantitative components (surveys). The investigators will identify patients with COVID-19 and recruited for qualitative interviews following hospital discharge or diagnosis. Patient caregivers will also be eligible to participate in study interviews. Interviews will occur once at various times ranging 2 weeks to 1 year since a patient's COVID-19 diagnosis. Surveys will be completed at 3 time points, 2-8 weeks after diagnosis or discharge to home, and then 6 months and 12 months later. Surveys will include the EQ-5D-5L profile for health-related quality of life, and the WHODAS 2.0 score for a global assessment of overall physical and psychosocial function. Investigators will also identify a comparator cohort of patients who have been diagnosed with lower respiratory tract infection (LRTI) in the setting of a negative COVID-19 test. Surveys will be administered at the same interval and analysis will determine if COVID-19 has different and more severe health impacts than other causes of lower respiratory tract infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID Positive | Veterans aged 18 years or older who have a positive SARS-CoV-2 diagnosis (confirmed or presumptive) or who have been discharged home within 2 weeks to 1 year of diagnosis | ||
| COVID Negative and Lower Respiratory Tract Infection (LRTI) | Veterans aged 18 years or older with a negative SARS-CoV-2 test (PCR and/or antigen test) and diagnosis of LRTI after discharge home or after diagnosis if not hospitalized |
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| Measure | Description | Time Frame |
|---|---|---|
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score | Profile for health-related quality of life. The investigators will summarize this measure with a visual analog score (VAS). The VAS ranges from 0 to 100mm (where 0="the worst health you can imagine"; 100="the best health you can imagine"). | Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12 |
| WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | Global assessment of overall physical and psychosocial function. The overall score for disability will be calculated using item-response-theory (IRT) based scoring. This scale ranges from 0 to 100 (where 0 = no disability; 100 = full disability). | Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12 |
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index | Profile for health-related quality of life. We will summarize this measure with an overall utility index. The utility index ranges from less than 0 to 1(where <0="worse than death";1=full health). | Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Veterans aged 18 years or older who have a positive SARS-CoV-2 diagnosis (confirmed or presumptive) or who have been discharged home within 2 weeks to 1 year of diagnosis. Those who do not speak English or have cognitive limitations that preclude the ability to communicate and obtain informed consent will be excluded
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| Name | Affiliation | Role |
|---|---|---|
| Kristina A Crothers, MD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105-2303 | United States | ||
| VA Puget Sound Health Care System Seattle Division, Seattle, WA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40505809 | Derived | Turner AP, Adams SV, Hawkins E, Fan VS, Nikzad R, Kundzins JR, Crothers K. Alcohol Use and COVID-19 Outcomes. Chest. 2025 Sep;168(3):589-601. doi: 10.1016/j.chest.2025.05.039. Epub 2025 Jun 10. | |
| 40375042 | Derived | Petrova VV, Turner AP, Simons C, Kamiab NA, Crothers K, Sayre GG. Veterans' Experiences with COVID-19 and How Providers Can Shape Care and Perception with Empathy. J Gen Intern Med. 2025 May 15. doi: 10.1007/s11606-025-09557-9. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2024 | Oct 1, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Seattle |
| Washington |
| 98108-1532 |
| United States |
| 38530061 | Derived | Crothers K, Adams SV, Turner AP, Batten L, Nikzad R, Kundzins JR, Fan VS. COVID-19 Severity and Mortality in Veterans with Chronic Lung Disease. Ann Am Thorac Soc. 2024 Jul;21(7):1034-1043. doi: 10.1513/AnnalsATS.202311-974OC. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |