Investigating Idiopathic Pulmonary Fibrosis in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 7
- 主要终点
- Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
研究概览
简要总结
To gain further insight on the characteristics, management, disease progression and the outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice conditions in Greece. More specifically, this registry will be used to: Provide a comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF patients over time, Examine the implementation of treatment guidelines used on patients diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of patients on different treatments. To provide information regarding survival and mortality causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis, hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF patient hospitalization will be collected and evaluated with regards to potential respiratory causes, and there will be documentation of treatment patterns and economic aspects. Patients will be followed up for 2 years and information regarding IPF treatment changes since the last visit will be collected.
详细描述
Purpose: To gain further knowledge on the characteristics, management, progression and outcomes of patients with IPF as treated under real-world, clinical practice conditions in Greece
Study Design:
National, multi-center, observational disease registry based on new data from a significant sample size of IPF patients in Greece. Patients will be followed up for 2 years and information will be collected during this time period. This is a non-interventional study and primary data collected during study visits will be used
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
时间窗: At baseline visit and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number in each category of non-pharmacological treatment (e.g. start of Long-term oxygen therapy (LTOT), new listing for lung transplantation, physiotherapy) for Idiopathic Pulmonary Fibrosis (IPF) by study visit is reported. The categories of non-pharmacological treatment for Idiopathic Pulmonary Fibrosis (IPF) are the following: * No * Yes * Unknown * Missing
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
时间窗: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of patients in each category of physician's clinical assessment of the probable course of IPF by study visit is reported. Physician's clinical rating of the probable course of IPF (stable, slow or rapid progression) was based on available Forced vital capacity (FVC) results, diffusion capacity for carbon monoxide (DLCO) results, physical examination, hospitalizations/events between the visits. The categories of physician's clinical assessment are the following: * Stable disease * Slow progression * Rapid progression * No judgement possible * Missing
Number of Physician Contacts Per Patient by Study Visit
时间窗: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of physician contacts per patient is reported. For the baseline visit mean and standard deviation of physician contacts with the patient up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of physician contacts with the patient since the last study visit is reported.
Number of Visits in Outpatient Department by Study Visit
时间窗: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of visits in outpatient department by study visit is reported. For the baseline visit mean and standard deviation of visits in outpatient department up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in outpatient department since the last study visit is reported.
Number of Visits in Pulmonologists by Study Visit
时间窗: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of visits in pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in pulmonologists since the last study visit is reported.
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
时间窗: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of visits in other physicians than the pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in other physicians than the pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in other physicians than the pulmonologists since the last study visit is reported.
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
时间窗: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Idiopathic Pulmonary Fibrosis (IPF) related procedures by study visit is reported. For the baseline visit mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures since the last study visit is reported.
Number of Patients in Each Category of Hospitalizations by Study Visit
时间窗: At baseline up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of patients in each category of hospitalizations by study visit is reported. For the baseline visit number of patients in each category of hospitalizations up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months number of patients in each category of hospitalizations since the last study visit is reported. The categories of hospitalization were: * No * Yes * Unknown * Missing
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
时间窗: From signing the informed consent onwards until the end of the study, up to 24 months.
Number of patients in each category with usage of pirfenidone and nintedanib is reported. The categories for usage of pirfenidone and nintedanib are the following: * Yes * No * Unknown * Missing
次要结局
- Number of Patients in Each Category of Concomitant Medications(From signing the informed consent onwards until the end of the study, up to 24 months.)