Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

622 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-27

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Chronic Lung Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* (Patients in COVID-19 cohort) VA patients diagnosed with COVID-19 through a positive PCR (Polymerase Chain Reaction) or antigen SARS-CoV-2 test conducted in VA
* (Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
* (Patients in LRTI cohort) VA patients diagnosed with LRTI and tested negative for COVID-19 (through PCR and/or antigen test)