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

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 Overview

• Status: Completed
• Conditions: Quality of Life; Coronavirus Infection; Long-term Outcomes
• Intervention / Treatment: Other: COVID-19 Severity

• Study Type: Observational
• Enrollment (Actual): 1508

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital Moinhos de Vento

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 (Coalition I); Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with up to 4L/minute oxygen supply through nasal catheter.	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
Cohort 2 (Coalition II); Adult hospitalized patients with proven or suspected SARS-Cov-2 infection needing oxygen supplementation > 4L/min on nasal catheter or HFNC or NIV or MV or ECMO.	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
Cohort 3 (Coalition III); Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with moderate or severe ARDS according to the Berlin definition	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
Cohort 4 (Coalition IV); Adult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range	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
Cohort 5 (Coalition VI); Adult hospitalized patients with proven SARS-Cov-2, needing oxygen supplementation to maintain SpO2 > 93%, and two or more of the following inflammatory tests: D-dimer > 1,000 ng/mL; C reactive protein (CRP) > 5 mg/dL; Ferritin > 300 mg/dL; Lactate dehydrogenase (LDH) > upper limit of normal	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The outcome will be assessed 12 months after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all-cause mortality	Incidence of all-cause mortality.	The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Incidence of rehospitalizations	Incidence of all-cause rehospitalizations.	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.	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).	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.	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.	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).	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).	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).	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).	The outcome will be assessed 3, 6, 9, and 12 months after enrollment.

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Collaborators: Hospital Israelita Albert Einstein; Brazilian Clinical Research Institute; Hospital do Coracao; Hospital Sirio-Libanes; Hospital Alemão Oswaldo Cruz; Beneficência Portuguesa de São Paulo; Brazilian Research In Intensive Care Network

Publications and helpful links

General Publications

• Rosa RG, Robinson CC, Veiga VC, Cavalcanti AB, Azevedo LCP, Machado FR, Berwanger O, Avezum A, Lopes RD, Lisboa TC, Teixeira C, Zampieri FG, Tomazini BM, Kawano-Dourado L, Schneider D, Souza D, Santos RDRMD, Silva SSD, Trott G, Gimenes BDP, Souza AP, Barroso BM, Costa LS, Brognoli LG, Pelliccioli MP, Studier NDS, Schardosim RFC, Haubert TA, Pallaoro VEL, Oliveira DM, Velho PI, Medeiros GS, Gazzana MB, Zavascki AP, Pitrez PM, Oliveira RP, Polanczyk CA, Nasi LA, Hammes LS, Falavigna M. Quality of life and long-term outcomes after hospitalization for COVID-19: Protocol for a prospective cohort study (Coalition VII). Rev Bras Ter Intensiva. 2021 Jan-Mar;33(1):31-37. doi: 10.5935/0103-507X.20210003.

Helpful Links

• Study Protocol

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: Coalition COVID-19: Long-term

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No