Quality of LifeNCT04416464
Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19
An observational study of Quality of Life and Long-term Outcomes, run by Universidade do Porto at 3 sites in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Long-term Outcomes, Coronavirus Infection
- What is being tested?
- COVID-19 Pneumonia
- How many people
- 280 participants
- Where
- 3 sitesPortugal
- Study dates
- 15 Jun 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult survivors of ICU admission and pneumonia due to proven or suspected SARS-CoV-2 infection.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Centro Hospitalar Universitário de São João
Porto
Centro Hospitalar Universitário do Porto - Hospital de Santo António
Porto
Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I
Vila Nova de Gaia, Porto District, 4434-502
About this study
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
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.
- Being tested
- COVID-19 Pneumonia
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 PneumoniaOther
Pneumonia due to proven or suspected SARS-Cov-2 infection
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia due to SARS-CoV-2 infection | Adult hospitalized patients with pneumonia due to proven or suspected SARS-Cov-2 infection. Receives: Other: COVID-19 Pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One-year (12 months) after ICU discharge.
Secondary outcomes (13)
Length of stay at the ICU.
Length of stay at the ICU.
Measured: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).
Incidence of all-cause mortality
Incidence of all-cause mortality.
Measured: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Rehospitalization.
Rehospitalization.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Jun 2020
- Primary completion31 Jul 2021
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro Hospitalar do Porto, Universidade do Algarve, Centro Hospitalar Lisboa Ocidental
- Responsible party
- Sponsor
- Investigators
- Luís Filipe Azevedo, Prof., Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416464
- Sponsor's protocol ID
- QoL_ICU_COVID
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04416464
- Acronym / sponsor ID
- QoL_ICU_COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro Hospitalar do Porto, Universidade do Algarve, Centro Hospitalar Lisboa Ocidental
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumonia due to SARS-CoV-2 infection | – | Other: COVID-19 PneumoniaAdult hospitalized patients with pneumonia due to proven or suspected SARS-Cov-2 infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult survivors of ICU admission and pneumonia due to proven or suspected SARS-CoV-2 infection.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 PneumoniaPneumonia due to proven or suspected SARS-Cov-2 infection | Other | Pneumonia due to SARS-CoV-2 infection |
Primary outcome
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).
13 secondary outcomes
Length of stay at the ICU.
Time frame: 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.
Rehospitalization.
Time frame: 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 renal replacement therapy need.
Time frame: 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.
Score of functional independence.
Time frame: 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.
Percentage of major cardiac events.
Time frame: 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.
Symptoms of posttraumatic stress disorder
Time frame: 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.
Score of self-rated health.
Time frame: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: Undecided. The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luís Filipe Azevedo, Prof. principal investigator
Universidade do Porto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Long-term Outcomes, run by Universidade do Porto at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life. (time frame: One-year (12 months) after ICU discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.