NCT04376658

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

Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,508 (actual)
• Sponsor: Hospital Moinhos de Vento · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-07-15
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2020-05-06
• Last updated: 2022-07-06

Locations

1 site across 1 country: Brazil