LAUREL: Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs
Study Details
Study Description
Brief Summary
This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to provide rapid initial guidance for rehabilitation programs to anticipate care needs of COVID-19 survivors. The investigators will also conduct a mixed-methods study and follow 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. Lastly, the investigators will examine the feasibility and acceptability of a virtually delivered, home-based rehabilitation intervention for survivors of COVID-19, with components based on an individual patient's need.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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, 3-8 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.
Finally, the investigators will conduct a single-arm pilot feasibility trial to develop an initial feasibility testing of a rehabilitation-focused program to improve physical and psychosocial functioning. This will involve patients with COVID-19 who were discharged home or 2 weeks after diagnosis if not hospitalized.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Rehabilitation-focused program Subjects will receive multiple services in a rehabilitation-focused program |
Other: Rehabilitation-focused program
Subjects will receive 1) an initial assessment and personalized plan by a nurse care coordinator, 2) a CORE program consisting of upper and lower body exercises, and basic dyspnea management, and 3) individual symptom- and problem-focused modules identified in the initial assessment and then selected by participants as part of a personalized plan.
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Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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(Patients) VA patients diagnosed with COVID-19 through a positive PCR (Polymerase Chain Reaction) or antigen SARS-CoV-2 test conducted in VA
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(Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
Exclusion Criteria:
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Significant cognitive dysfunction
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Language barriers
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Severe psychiatric disorder impairing ability to participate in surveys and interviews
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | United States | 98108 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Kristina A Crothers, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- F3666-R
- 1I01RX003666-01