NCT05165979进行中（未招募）不适用
Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
- 试验地点
- 24
- 主要终点
- One-year utility score of health related quality of life
研究概览
简要总结
The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment.
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
- •Age ≥18 years;
- •Symptomatic COVID-19 disease within the last 14 days;
- •Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
- •Need of hospitalization (duration ≥ 48 hours).
排除标准
- •Severe comorbidity with life expectancy less than 3 months;
- •Death during hospitalization;
- •Absence of telephone contact;
- •Absence of proxy for patients with communication difficulties;
- •Refusal or withdrawal of agreement to participate;
- •Previous enrollment in the study.
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.
次要结局
- Instrumental Activities of Daily Living(The outcome will be assessed at 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 at 3, 6, and 9 months after enrollment.)
- Incidence of major cardiovascular events(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of anxiety and depression symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of rehospitalizations(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of prolonged COVID-19 symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of posttraumatic stress disorder symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of return to work or study(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of all-cause mortality(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of cognitive dysfunction(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of new symptomatic COVID-19 infection(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Physical functional status(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
研究者
研究点 (24)
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