Clinical trial NCT04416464: Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19
Official title: Quality of Life and Long-term Outcomes in Patients With Pneumonia Associated With SARS-Cov2 Infection, Survivors of Intensive Care Units: a Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Long-term Outcomes
Coronavirus Infection
Morality
Rehospitalization
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
name: Centro Hospitalar do Porto
name: Universidade do Algarve
name: Centro Hospitalar Lisboa Ocidental
First posted: 2020-06-04
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult survivors of ICU admission and pneumonia due to proven or suspected SARS-CoV-2 infection.

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.


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

Primary outcomes:
measure: Health-related quality of life.
timeFrame: One-year (12 months) after ICU discharge.
Secondary outcomes:
measure: Length of stay at the ICU.
timeFrame: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).
measure: Incidence of all-cause mortality
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Rehospitalization.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Percentage of long-term ventilatory support need.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Percentage of renal replacement therapy need.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Symptoms of anxiety and depression.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Score of functional independence.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Score of cognitive function.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Percentage of major cardiac events.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Score of Chronic obstructive pulmonary disease (COPD)
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Symptoms of posttraumatic stress disorder
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Utility score of health-related quality of life at 3, 6, and 9 months.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
measure: Score of self-rated health.
timeFrame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Other outcomes:
Locations:
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I
state: Porto
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto - Hospital de Santo António
Study officials:
affiliation: Universidade do Porto
name: Luís Filipe Azevedo, Prof.
role: PRINCIPAL_INVESTIGATOR
References: