EPOCH-Economics and Patient Outcomes in China in Haemophilia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Successfully registered research centers
研究概览
简要总结
The overarching goal of the EPOCH project is to:
- Support a broad and robust needs assessment in the haemophilia space in China
- Measure the variability in the needs and care provision
- Generate outcome data (health economic outcomes and supporting clinical and PRO data) to enable measuring the impact of different treatment modalities and different levels of treatment access PRIMARY OBJECTIVES
- Determine the burden of haemophilia in China, and the determinants of its variability
- Determine the costs of haemophilia care in China, and the determinants of its variability SECONDARY OBJECTIVES
- Measure treatment patterns and their variability
- Measure levels of access to care
- Estimate the impact of haemophilia and its treatment of patients reported outcomes
- Understand consistency of care by centres/geography/demographics
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Minutes 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients, aged ≥12 years at the index date
- •Patients must be diagnosed with non-acquired severe haemophilia A or B prior to the previous 12 months
- •Patients who are able to understand and assent / consent to the study
排除标准
- •Patients who cannot, for any reasons (language barriers, mental incapacity, etc.) understand and answer the questions of the study questionnaires
- •Patients that cannot access internet connection or download the application
结局指标
主要结局
Successfully registered research centers
时间窗: Baseline until week 52
Successfully registered research centers in Trial Phase
Number of enrolled patients
时间窗: Baseline until week 52
Number of enrolled patients in Trial Phase
Proportion of completed questionnaires
时间窗: Baseline until week 52
Proportion of completed questionnaires for the Trial Phase
Proportion of missing data
时间窗: Baseline until week 52
Proportion of missing data for the Trial Phase
Qualitative information on study barriers and facilitators
时间窗: Baseline until week 52
Qualitative information on study barriers and facilitators for the Trial Phase
Diagnostic and treatment burden for hemophilia patients
时间窗: Baseline until week 52
Diagnostic and treatment burden for hemophilia patients for the Implementation Phase
Costs of hemophilia diagnosis and treatment
时间窗: Baseline until week 52
Costs of hemophilia diagnosis and treatment for the Implementation Phase
次要结局
- Measure treatment patterns and their variability(Baseline until week 52)
- Measure levels of access to care(Baseline until week 52)
- Estimate the impact of haemophilia and its treatment on patients reported outcomes(Baseline until week 52)