COVID-19 Clinical Trial
— LAURELOfficial title:
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study)
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.
Status | Recruiting |
Enrollment | 476 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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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