NCT03386994已完成不适用
Observational Analysis on the Socio-economic Impact of IPF in Spain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 31
- 主要终点
- Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
研究概览
简要总结
Descriptive prospective non-interventional multicenter study based on newly collected data of Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings (Pulmonology Services)
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients ≥ 40 years of age
- •Patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to last ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management consensus
- •Written informed consent prior to participation
排除标准
- •Inability for the patient to understand or complete the written Inform Consent or patients questionnaires or to understand Spanish
- •Current participation in any clinical trial
- •Patients for whom further follow-up is not possible at the enrolling site
结局指标
主要结局
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
时间窗: 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).
The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age.
次要结局
- Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year(12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).)
- Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)(12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).)
- Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)(12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).)
- Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Subgroup: Predicted FVC 50-80% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index(12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).)
- Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0(12 months (At baseline visit (T0) and at 12 month visit (T12)).)
- Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Total Annual Acute Exacerbation-related Costs(12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).)
- Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire(12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).)
- Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Overall FVC Patient Group(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
- Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0(12 months. (At baseline visit (T0) and at 12 month visit (T12)).)
研究者
研究点 (31)
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