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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    506
  • sponsor
    VA Office of Research and Development
Updated on 14 June 2021

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.

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.

Details
Condition *COVID-19, Covid-19
Treatment Rehabilitation-focused program
Clinical Study IdentifierNCT04628039
SponsorVA Office of Research and Development
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

(Patients) VA patients diagnosed with COVID-19
(Caregivers) Providing caregiving to VA patients diagnosed with COVID-19

Exclusion Criteria

Significant cognitive dysfunction
Language barriers
Severe psychiatric disorder impairing ability to participate in surveys and interviews
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