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

COVID-19 Clinical Trial

— LAUREL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04628039
• Other study ID #: F3666-R
• Secondary ID: 1I01RX003666-01
• Status: Recruiting
• Start date: May 27, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Lisa Batten, MD MHA MPH
• Phone: (206) 768-5288
• Email: lisa.batten[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Lung Diseases
• COVID-19
• Lung Diseases

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

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