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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Coronavirus Infection; Morality; Rehospitalization; Long-term Outcomes
• Intervention / Treatment: Other: COVID-19 Pneumonia

• Study Type: Observational
• Enrollment (Actual): 280

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal
    • Centro Hospitalar Universitário de São João
  • Porto, Portugal
    • Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio
  • Porto
    • Vila Nova De Gaia, Porto, Portugal, 4434-502
      • Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I

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: Probability Sample

Study Population

Adult survivors of ICU admission and pneumonia due to proven or suspected SARS-CoV-2 infection.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pneumonia due to SARS-CoV-2 infection; Adult hospitalized patients with pneumonia due to proven or suspected SARS-Cov-2 infection.	Other: COVID-19 Pneumonia; Pneumonia due to proven or suspected SARS-Cov-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life.	The outcome will be assessed using the Portuguese 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).	One-year (12 months) after ICU discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay at the ICU.	Length of stay at the ICU.	The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).
Incidence of all-cause mortality	Incidence of all-cause mortality.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Rehospitalization.	Rehospitalization.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Percentage of long-term ventilatory support need.	Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Percentage of renal replacement therapy need.	Percentage of patients requiring any kind of renal replacement therapy.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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 at 3, 6, 9 and 12 months after ICU discharge.
Score of functional independence.	The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Score of cognitive function.	The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Percentage of major cardiac events.	Percentage of major cardiac events.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Score of Chronic obstructive pulmonary disease (COPD)	Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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 at 3, 6, 9 and 12 months after ICU discharge.
Utility score of health-related quality of life at 3, 6, and 9 months.	The outcome will be assessed using the Portuguese 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 at 3, 6, 9 and 12 months after ICU discharge.
Score of self-rated health.	The outcome will be assessed using the visual analogue scale of the Portuguese 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 at 3, 6, 9 and 12 months after ICU discharge.

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Centro Hospitalar Lisboa Ocidental; Centro Hospitalar De São João, E.P.E.; Centro Hospitalar do Porto; Universidade do Algarve
• Investigators: Principal Investigator: Luís Filipe Azevedo, Prof., Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Coronavirus Infections; Infections
• Other Study ID Numbers: QoL_ICU_COVID

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