Clinical trial NCT04376658: Quality of Life and Long-term Outcomes After Hospitalization for COVID-19
Official title: Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Long-term Outcomes
Coronavirus Infection
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Hospital Israelita Albert Einstein
name: Hospital Sirio-Libanes
name: Hospital do Coracao
name: Hospital Alemão Oswaldo Cruz
name: Beneficência Portuguesa de São Paulo
name: Brazilian Clinical Research Institute
name: Brazilian Research In Intensive Care Network
First posted: 2020-05-06
Enrollment: 1508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection

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.


Eligibility criteria: 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

Primary outcomes:
measure: One-year utility score of health-related quality of life
timeFrame: The outcome will be assessed 12 months after enrollment.
Secondary outcomes:
measure: Incidence of all-cause mortality
timeFrame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
measure: Incidence of rehospitalizations
timeFrame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
measure: Percentage of return to work or study
timeFrame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
measure: Score of Instrumental Activities of Daily Living
timeFrame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
measure: Score of dyspnea
timeFrame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.
measure: Percentage of long-term ventilatory support need
timeFrame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
measure: Symptoms of anxiety and depression
timeFrame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
measure: Symptoms of posttraumatic stress disorder
timeFrame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
measure: Utility score of health-related quality of life at 3, 6, and 9 months
timeFrame: The outcome will be assessed 3, 6, and 9 months after enrollment.
measure: Score of self-rated health
timeFrame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
Study officials:
References:
citation: 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.