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COVID19 LTFU: Long Term Outcomes of Patients With COVID-19

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04360538
Collaborator
(none)
500
Enrollment
1
Location
32.7
Anticipated Duration (Months)
15.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of Life
  • Other: Impact Event Score
  • Other: Hospital anxiety and depression scale

Detailed Description

The aim of this proposal to is to understand the extent and degree of physical disability, psychological sequelae, and cognitive dysfunction survivors of COVID-19 related critical illness will have upon hospital discharge, 6 months, and up to one year post discharge. These outcomes of interest will be evaluated prospectively. The investigators will perform these measures in Covid-19 patients with respiratory failure and compare them to non-Covid-19 patients with respiratory failure. The investigators also seek to determine the risk factors of these long-term complications in order to guide providers as to which patients should be screened for these deficits. Finally, the investigators will examine the association of various critical care interventions such as invasive versus noninvasive mechanical ventilation or use of sedatives and their effects on disability and cognitive dysfunction.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Outcomes of Patients With COVID-19
Actual Study Start Date :
Apr 8, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
COVID19 positive

ICU patients coronavirus positive

Other: Quality of Life
Physical disability assessment tool
Other Names:
  • SF-36

    • Other: Impact Event Score
    Psychological Sequelae assessment tool
    Other Names:
  • IES-R

    • Other: Hospital anxiety and depression scale
    Psychological Sequelae assessment tool
    non-COVID19

    ICU patients without coronavirus

    Other: Quality of Life
    Physical disability assessment tool
    Other Names:
  • SF-36

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life score [up to 12 months after discharge]

      SF-36 score

    Secondary Outcome Measures

    1. cognitive dysfunction [up to 12 months after discharge]

      Montreal Cognitive Assessment (MoCA) score

    2. Functional Status Score [up to 12 months after discharge]

      (FSS-ICU)

    3. Physical Disability [up to 12 months after discharge]

      MRC neuromuscular Assessment

    4. Psychological Sequelae [up to 12 months after discharge]

      Impact Event Score

    Other Outcome Measures

    1. hospital anxiety and depression [up to 12 months after discharge]

      hospital anxiety and depression scale

    2. ICU related complications [hospitalization up to 6 weeks]

      including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness

    3. hospital discharge location [hospital discharge up to 6 weeks]

      measure the location (home, rehabilitation center, nursing home

    4. lCU length of stay [hospitalization up to 6 weeks]

      number of days admitted to the ICU

    5. hospital length of stay [hospitalization up to 6 weeks]

      number of days admitted to the hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • adult patients admitted to the ICU
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Medical Center Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT04360538
    Other Study ID Numbers:
    • 20-0538
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Apr 29, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Chicago
    long term outcomes
    mechanical ventilation
    noninvasive ventilation
    Additional relevant MeSH terms:
    COVID-19
    Coronavirus Infections
    Respiratory Insufficiency
    Critical Illness

    Study Results

    No Results Posted as of Apr 29, 2021