Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,508
- 试验地点
- 1
- 主要终点
- One-year utility score of health-related quality of life
研究概览
简要总结
The present study aims to assess the determinants of health-related quality of life and long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton & Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised.
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
- •Patients aged 18 years and older
- •Hospitalization due to proven or suspected SARS-CoV-2 infection
- •Meeting eligibility criteria for Coalition Covid-19 Brazil randomized clinical trials
排除标准
- •Death during the hospitalization
- •Absence of telephone contact
- •Absence of proxy for patients with communication difficulties
- •Refusal or withdrawal of agreement to participate
结局指标
主要结局
One-year utility score of health-related quality of life
时间窗: The outcome will be assessed 12 months after enrollment.
The outcome will be assessed using the Brazilian 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
- Score of self-rated health(The outcome will be assessed 3, 6, 9, and 12 months after enrollment.)
- Score of Instrumental Activities of Daily Living(The outcome will be assessed 3, 6, 9 and 12 months after enrollment.)
- Score of dyspnea(The outcome will be assessed 3, 6, 9, and 12 months after enrollment.)
- Symptoms of posttraumatic stress disorder(The outcome will be assessed 3, 6, 9 and 12 months after enrollment.)
- Utility score of health-related quality of life at 3, 6, and 9 months(The outcome will be assessed 3, 6, and 9 months after enrollment.)
- Incidence of rehospitalizations(The outcome will be assessed 3, 6, 9 and 12 months after enrollment.)
- Percentage of return to work or study(The outcome will be assessed 3, 6, 9 and 12 months after enrollment.)
- Symptoms of anxiety and depression(The outcome will be assessed 3, 6, 9 and 12 months after enrollment.)
- Incidence of all-cause mortality(The outcome will be assessed 3, 6, 9 and 12 months after enrollment.)
- Percentage of long-term ventilatory support need(The outcome will be assessed 3, 6, 9 and 12 months after enrollment.)