A Real-World Study of the Perceived Emotional and Social Experiences Related to Antifibrotic Therapy in Patients With IPF and PPF: A Cross-Sectional Web-Based Survey
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
研究概览
简要总结
This is a cross-sectional study that will be conducted across Japan using an online patient-reported outcome questionnaire.
This study tries to find out the attitudes toward and experiences of the emotional and/or social impact of side effects associated with antifibrotic (AF) treatment among Japanese patients with Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF), and how are these attitudes associated with patients' individual characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients with IPF aged 40 years or older who received nintedanib or pirfenidone within the previous 4 weeks, or patients with PPF aged 18 years or older who received nintedanib within the previous 4 weeks
- •Patients capable of responding to a self-administered questionnaire
排除标准
- •Patients treated with nerandomilast (including clinical trials)
- •Patients with PPF treated with pirfenidone
- •Patients currently hospitalized
- •Patients with malignant tumors
研究组 & 干预措施
Japanese patients with IPF/PPF
结局指标
主要结局
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
时间窗: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The score of patient experiences and satisfaction with medications (PESaM) side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.
次要结局
- Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment(Assessed once at survey completion (approximately 20 minutes after survey initiation).)
- Mean (95% CI) scores for the EQ-5D-5L(Assessed once at survey completion (approximately 20 minutes after survey initiation).)
- Mean (95% CI) scores for the SDM-Q-9(Assessed once at survey completion (approximately 20 minutes after survey initiation).)
- Reliability (Cronbach's α) of PESaM side effects sub-domain(Assessed once at survey completion (approximately 20 minutes after survey initiation).)
- Validity (correlation with EQ-5D-5L) of PESaM side effects sub-domain(Assessed once at survey completion (approximately 20 minutes after survey initiation).)
- Correlation between PESaM side effects sub-domain and SDM-Q-9(Assessed once at survey completion (approximately 20 minutes after survey initiation).)
- Descriptive statistics of patient background in high- and low-score groups for the PESaM side effects sub-domain(Assessed once at survey completion (approximately 20 minutes after survey initiation).)
- Clinical characteristics in high- and low-score groups for the PESaM side effects sub-domain(Assessed once at survey completion (approximately 20 minutes after survey initiation).)