Non-interventional Prospective Study in Patients With Pulmonary Fibrosis Treated With Nintedanib Participating in a Patient Support Program in Spain, to Describe Patient Satisfaction With the Program and to Monitor Quality of Life - BALANCE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.
研究概览
简要总结
The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.
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
- •Adults (≥18 years old at baseline).
- •Patients included in the Patient Support Program (PSP) Balance Program.
- •Ability to read and speak Spanish correctly according to the investigator criteria.
- •Agree to participate and signing informed consent at baseline.
排除标准
- •- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.
研究组 & 干预措施
Patients participating in the PSP Balance Program
结局指标
主要结局
Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.
时间窗: at Baseline
Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published. Items in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.
次要结局
- Dosing pattern of nintedanib calculated as absolute number of doses taken correctly divided by all the doses prescribed in that period (6 and 12 months)(up to 12 months)
- Time from first dose to permanent discontinuation of nintedanib within 12-month follow-up.(up to 12 months)
- Absolute number of nintedanib dose interruptions.(up to 12 months)
- 1. Change in the satisfaction with Patient Support Program (PSP) Balance Program at 6 and 12-month follow-up after inclusion in the study, using the Baker Questionnaire.(up to 12 months)
- Patient satisfaction with PSP Balance Program at baseline, 6 and 12 months after the inclusion in the study using the Likert scale.(at baseline and up to 12 months)
- Health-Related Quality of Life (HRQoL) at baseline and 12-month follow-up using the L-PF Impacts Questionnaire.(at baseline and up to 12 months)
- Anxiety and depression scores in Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and 12-month follow-up.(at baseline and up to 12 months)
- Disease symptoms score in Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire at baseline and 12 months follow-up.(at baseline and up to 12 months)
- Absolute number of visits to emergency service and hospitalization related to Interstitial Lung Disease (ILD) between baseline and 12-month follow-up.(up to 12 months)