Quality of Life and Long-term Outcomes After Hospitalization for COVID-19

NCT04376658 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1508

Last updated 2022-07-06

No results posted yet for this study

Summary

The present study aims to assess the determinants of health-related quality of life and long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton \& Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised.

Conditions

  • Quality of Life
  • Long-term Outcomes
  • Coronavirus Infection

Interventions

OTHER

COVID-19 Severity

Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    collaborator OTHER
  • Hospital Sirio-Libanes

    collaborator OTHER
  • Hospital do Coracao

    collaborator OTHER
  • Hospital Alemão Oswaldo Cruz

    collaborator OTHER
  • Beneficência Portuguesa de São Paulo

    collaborator OTHER
  • Brazilian Clinical Research Institute

    collaborator OTHER
  • Brazilian Research In Intensive Care Network

    collaborator NETWORK
  • Hospital Moinhos de Vento

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2022-03-11
Completion
2022-03-11

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04376658 on ClinicalTrials.gov