Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs
- Conditions
- COVID-19Chronic Lung Diseases
- Registration Number
- NCT04628039
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 476
- (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)
- Cognitive limitations that preclude the ability to communicate and obtain informed consent
- Language barriers
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12 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").
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12 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).
EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
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