Official Title
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study)
Brief Summary

This is study is comprised of three approaches. First, the investigators will conduct aretrospective cohort study to determine factors associated with COVID-19 severity andcomplications and understand COVID-19 outcomes, including all-cause mortality,post-discharge events, and impacts of rehabilitation services (third aim). The second aimis a mixed-method study and follows COVID-19 patients with repeated surveys to determinepatient-reported functional outcomes, health recovery, and rehabilitation needs afterCOVID-19. The investigators will recruit patients and their informal caregivers forinterviews to assess their function and rehabilitation needs.

Detailed Description

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.

Recruiting
COVID-19
Chronic Lung Diseases
Eligibility Criteria

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)

Exclusion Criteria:

- Cognitive limitations that preclude the ability to communicate and obtain informed
consent

- Language barriers

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States

Contacts

John R Kundzins, BS
(206) 277-1515
John.Kundzins@va.gov

Kristina A Crothers, MD, Principal Investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA

VA Office of Research and Development
NCT Number
Keywords
Chronic Lung Disease
Covid-19
Rehabilitation
Veterans
SARS-CoV-2
COPD
MeSH Terms
COVID-19
Lung Diseases