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
试验速览
- 阶段
- 不适用
- 入组人数
- 280
- 试验地点
- 3
- 主要终点
- Health-related quality of life.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Health-related quality of life.
时间窗: 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).
次要结局
- 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)(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 at 3, 6, 9 and 12 months after ICU discharge.)
- Score of cognitive function.(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 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.)
- Symptoms of posttraumatic stress disorder(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 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.)
- Score of functional independence.(The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.)
- Length of stay at the ICU.(The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).)
- Percentage of long-term ventilatory support need.(The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.)
- Percentage of renal replacement therapy need.(The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.)