Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.
Study Type
OBSERVATIONAL
Enrollment
280
Pneumonia due to proven or suspected SARS-Cov-2 infection
Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I
Vila Nova de Gaia, Porto District, Portugal
Centro Hospitalar Universitário de São João
Porto, Portugal
Centro Hospitalar Universitário do Porto - Hospital de Santo António
Porto, Portugal
Health-related quality of life.
The outcome will be assessed using the Portuguese 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: One-year (12 months) after ICU discharge.
Length of stay at the ICU.
Length of stay at the ICU.
Time frame: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).
Incidence of all-cause mortality
Incidence of all-cause mortality.
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Rehospitalization.
Rehospitalization.
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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 at 3, 6, 9 and 12 months after ICU discharge.
Percentage of renal replacement therapy need.
Percentage of patients requiring any kind of renal replacement therapy.
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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 at 3, 6, 9 and 12 months after ICU discharge.
Score of functional independence.
The outcome will be assessed using the Lawton \& Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Score of cognitive function.
The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Percentage of major cardiac events.
Percentage of major cardiac events.
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Score of Chronic obstructive pulmonary disease (COPD)
Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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 at 3, 6, 9 and 12 months after ICU discharge.
Utility score of health-related quality of life at 3, 6, and 9 months.
The outcome will be assessed using the Portuguese 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 at 3, 6, 9 and 12 months after ICU discharge.
Score of self-rated health.
The outcome will be assessed using the visual analogue scale of the Portuguese 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 at 3, 6, 9 and 12 months after ICU discharge.
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