Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease. Correlation Between the Model for End-Stage Liver Disease (MELD)-Na and the Edmonton Symptom Assessment System Scale (ESAS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- MELD ESAS
研究概览
简要总结
The goal of this observational study is to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease.
All patients with chronic liver disease will be invited to participate in the study. Patients will be followed prospectively with assessment of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale.
详细描述
- Methodology - Prospective observational study
- Population - All patients with chronic liver disease followed in the Matosinhos Local Health Unit after their first episode of decompensation or are diagnosed with hepatocellular carcinoma in stage C or D of the Barcelona Liver Clinic Cancer will be invited to participate in the study.
All patients who do not sign consent to participate, patients under 18 years of age and patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2, will be excluded. 3. Sample - Non-probabilistic for convenience 4. Data collection instrument - Patients will be followed prospectively with quarterly assessment, or after each episode of decompensation, of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale (ESAS), with introduction of 3 other symptoms prevalent in patients with chronic liver disease: sexual dysfunction sexual, cramps and pruritus. The minimum analysis for each patient will be 2 assessments.
All symptoms greater than 5 points will be considered moderate to severe and formal referral to the palliative care team will be discussed with the patient and their attending physician. Subsequently evaluating its effectiveness in symptomatic control. 5. Aims - This observational study will try to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease. As well as the influence that the implementation of palliative care have on symptom burden of advanced chronic liver disease patients.
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
- •All patients with chronic liver disease
排除标准
- •do not sign consent to participate
- •patients under 18 years of age
- •patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2
结局指标
主要结局
MELD ESAS
时间窗: 1 year
Evaluate and correlate the evolution of MELD-Na and ESAS on advanced chronic liver disease.
次要结局
未报告次要终点
研究者
Hugo Miguel Oliveira
Principal Investigator
Universidade do Porto
