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

September 9, 2021 updated by: Universidade do Porto

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal
        • Centro Hospitalar Universitario de Sao Joao
      • Porto, Portugal
        • Centro Hospitalar Universitário 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life.
Time Frame: One-year (12 months) after ICU discharge.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of stay at the ICU.
Time Frame: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).
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
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Incidence of all-cause mortality.
The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Rehospitalization.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Rehospitalization.
The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Percentage of long-term ventilatory support need.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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)
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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.
Time Frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Porto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro Hospitalar Lisboa Ocidental
Centro Hospitalar De São João, E.P.E.
Centro Hospitalar do Porto
Universidade do Algarve

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luís Filipe Azevedo, Prof., Universidade do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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