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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376658
• Other study ID #: Coalition COVID-19: Long-term
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: March 11, 2022

Study information

• Verified date: June 2022
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1508
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Long-term Outcomes
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul

Sponsors (8)

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

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Rosa RG, Robinson CC, Veiga VC, Cavalcanti AB, Azevedo LCP, Machado FR, Berwanger O, Avezum Á, 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. Portuguese, English. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of all-cause mortality	Incidence of all-cause mortality.	The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Secondary	Incidence of rehospitalizations	Incidence of all-cause rehospitalizations.	The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Study Protocol