Coronavirus Infection, Long-term Outcomes, Quality of Life
Conditions
Brief 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.
Interventions
OTHERCOVID-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
Hospital Israelita Albert Einstein
Hospital Sirio-Libanes
Hospital do Coracao
Hospital Alemão Oswaldo Cruz
Beneficência Portuguesa de São Paulo
Brazilian Clinical Research Institute
Brazilian Research In Intensive Care Network
Hospital Moinhos de Vento
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and older * Hospitalization due to proven or suspected SARS-CoV-2 infection * Meeting eligibility criteria for Coalition Covid-19 Brazil randomized clinical trials
Exclusion criteria
* Death during the hospitalization * Absence of telephone contact * Absence of proxy for patients with communication difficulties * Refusal or withdrawal of agreement to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year utility score of health-related quality of life | The outcome will be assessed 12 months after enrollment. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of rehospitalizations | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | Incidence of all-cause rehospitalizations. |
| Percentage of return to work or study | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | Percentage of return to work or study among patients that were working or studying at the moment of hospitalization. |
| Score of Instrumental Activities of Daily Living | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 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). |
| Score of dyspnea | The outcome will be assessed 3, 6, 9, and 12 months after enrollment. | 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. |
| Incidence of all-cause mortality | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | Incidence of all-cause mortality. |
| Symptoms of anxiety and depression | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 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). |
| Symptoms of posttraumatic stress disorder | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms). |
| Utility score of health-related quality of life at 3, 6, and 9 months | The outcome will be assessed 3, 6, and 9 months after enrollment. | 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). |
| Score of self-rated health | The outcome will be assessed 3, 6, 9, and 12 months after enrollment. | 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). |
| Percentage of long-term ventilatory support need | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation. |
Countries
Brazil
Outcome results
None listed