Clinical trial NCT04628039: Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs
Official title: Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Chronic Lung Diseases
Keywords: Chronic Lung Disease
COVID-19
Rehabilitation
Veterans
SARS-CoV-2
COPD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-11-13
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

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.

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

Primary outcomes:
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score
timeFrame: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index
timeFrame: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Kristina A Crothers, MD
role: PRINCIPAL_INVESTIGATOR
References: