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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04416464
• Other study ID #: QoL_ICU_COVID
• Status: Active, not recruiting
• Start date: June 15, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2021
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: October 1, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Infection
• Long-term Outcomes
• Morality
• Quality of Life
• Rehospitalization

Intervention

Other:
• COVID-19 Pneumonia
Pneumonia due to proven or suspected SARS-Cov-2 infection

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário de São João	Porto
Portugal	Centro Hospitalar Universitário do Porto - Hospital de Santo António	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I	Vila Nova De Gaia	Porto

Sponsors (5)

Lead Sponsor	Collaborator
Universidade do Porto	Centro Hospitalar De São João, E.P.E., Centro Hospitalar do Porto, Centro Hospitalar Lisboa Ocidental, Universidade do Algarve

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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.
Secondary	Rehospitalization.	Rehospitalization.	The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.