Geraldine Trott et al. Fernando Luis Scolari Marciane Maria Rover Mariana Motta Dias da Silva … Denise de Souza Rosa da Rosa Minho dos Santos Raíne Fogliati de Carli Schardosim Gabriela Soares Rech Juliana de Mesquita Neto Gabriel Pozza Estivalete Hellen Jordan Martins Freitas Carolina Rothmann Itaqui Amanda Christina Kozesinski-Nakatani Andreia Biolo Milena Soriano Marcolino Bruna Brandão Barreto Paulo Roberto Schvartzman Ana Carolina Peçanha Antonio Caroline Cabral Robinson Maicon Falavigna Carisi Anne Polanczyk Regis Goulart Rosa
Abstract
Background
The long-term impact of hospitalization for COVID-19 on patients’ physical, mental, and cognitive health still needs further assessment.
Objectives
This study aims to evaluate factors associated with quality of life and cardiovascular and non-cardiovascular outcomes 12 months after hospitalization for COVID-19.
Methods
This prospective multicenter study intends to enroll 611 patients hospitalized due to COVID-19 (NCT05165979). Centralized telephone interviews are scheduled to occur at three, six, nine, and 12 months after hospital discharge. The primary endpoint is defined as the health-related quality-of-life utility score assessed by the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints are defined as the EQ-5D-3L at three, six and nine months, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms, major cardiovascular events, rehospitalization, as well as all-cause mortality at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value <0.05 will be assumed as statistically significant for all analyses.
Results
The primary endpoint will be presented as the frequency of the EQ-5D-3L score 12 months after COVID-19 hospitalization. A sub-analysis to identify possible associations of independent variables with study outcomes will be presented.
Conclusions
This study will determine the impact of COVID-19 on the quality of life and cardiovascular and non-cardiovascular outcomes of hospitalized patients 12 months after discharge providing insights to the public health system in Brazil.