Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19

NCT ID: NCT04416464

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-10-01

Brief Summary

Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.

Conditions

Quality of Life; Long-term Outcomes; Coronavirus Infection; Morality; Rehospitalization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pneumonia due to SARS-CoV-2 infection

Adult hospitalized patients with pneumonia due to proven or suspected SARS-Cov-2 infection.

COVID-19 Pneumonia

Intervention Type: OTHER

Pneumonia due to proven or suspected SARS-Cov-2 infection

Interventions

COVID-19 Pneumonia

Pneumonia due to proven or suspected SARS-Cov-2 infection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women aged 18 years and older
• Admission to the intensive care unit (ICU)
• Pneumonia due to proven or suspected SARS-CoV-2 infection

Exclusion Criteria

• Refusal to provide consent for the study by the patient or legal guardian
• ICU length of stay less than 24 hours
• Absence of telephone contact

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role: collaborator

Centro Hospitalar do Porto

OTHER

Sponsor Role: collaborator

Universidade do Algarve

OTHER

Sponsor Role: collaborator

Centro Hospitalar Lisboa Ocidental

OTHER_GOV

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luís Filipe Azevedo, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I

Vila Nova de Gaia, Porto District, Portugal

Centro Hospitalar Universitário de São João

Porto, , Portugal

Centro Hospitalar Universitário do Porto - Hospital de Santo António

Porto, , Portugal

Countries

Portugal

Other Identifiers

QoL_ICU_COVID

Identifier Type: -

Identifier Source: org_study_id