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

NCT04628039 | Completed

• 2 other identifiers: F3666-R1I01RX003666-01
• Study Type: observational
• Target: 622
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19; Chronic Lung Diseases

Keywords

Chronic Lung Disease; COVID-19; Rehabilitation; Veterans; SARS-CoV-2; COPD

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

COVID Positive

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

COVID Negative and Lower Respiratory Tract Infection (LRTI)

Veterans aged 18 years or older with a negative SARS-CoV-2 test (PCR and/or antigen test) and diagnosis of LRTI after discharge home or after diagnosis if not hospitalized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• (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)

You may not qualify if:

• Cognitive limitations that preclude the ability to communicate and obtain informed consent
• Language barriers

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (3)

• Turner AP, Adams SV, Hawkins E, Fan VS, Nikzad R, Kundzins JR, Crothers K. Alcohol Use and COVID-19 Outcomes. Chest. 2025 Sep;168(3):589-601. doi: 10.1016/j.chest.2025.05.039. Epub 2025 Jun 10.

  PMID: 40505809 DERIVED

• Petrova VV, Turner AP, Simons C, Kamiab NA, Crothers K, Sayre GG. Veterans' Experiences with COVID-19 and How Providers Can Shape Care and Perception with Empathy. J Gen Intern Med. 2025 May 15. doi: 10.1007/s11606-025-09557-9. Online ahead of print.

  PMID: 40375042 DERIVED

• Crothers K, Adams SV, Turner AP, Batten L, Nikzad R, Kundzins JR, Fan VS. COVID-19 Severity and Mortality in Veterans with Chronic Lung Disease. Ann Am Thorac Soc. 2024 Jul;21(7):1034-1043. doi: 10.1513/AnnalsATS.202311-974OC.

  PMID: 38530061 DERIVED

MeSH Terms

Conditions

COVID-19; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina A Crothers, MD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 13, 2020
• Study Start: May 27, 2021
• Primary Completion: November 12, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)