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.
Study Type
OBSERVATIONAL
Enrollment
1,508
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
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
One-year utility score of health-related quality of life
The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Time frame: The outcome will be assessed 12 months after enrollment.
Incidence of all-cause mortality
Incidence of all-cause mortality.
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Incidence of rehospitalizations
Incidence of all-cause rehospitalizations.
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Percentage of return to work or study
Percentage of return to work or study among patients that were working or studying at the moment of hospitalization.
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Score of Instrumental Activities of Daily Living
The outcome will be assessed using the Lawton \& Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence).
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Score of dyspnea
The outcome will be assessed using the modified medical research council dyspnea scale. Scores ranges from 0 to 4, with higher scores indicating worse symptoms.
Time frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.
Percentage of long-term ventilatory support need
Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Symptoms of anxiety and depression
The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Symptoms of posttraumatic stress disorder
The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Utility score of health-related quality of life at 3, 6, and 9 months
The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Time frame: The outcome will be assessed 3, 6, and 9 months after enrollment.
Score of self-rated health
The outcome will be assessed using the visual analogue scale of the Brazilian version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).
Time frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.
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