A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
研究概览
简要总结
Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced vital capacity (FVC; daily), impact of IPF on daily life (weekly) and other symptoms. Objectives are to characterise acceptability of patientMpower platform from patient & healthcare professional perspective, impact of active engagement and self-monitoring using patientMpower platform on Patient Reported Outcome Measures (PROMs) in IPF, impact of patientMpower platform on medication compliance and correlation between patient-reported PROMs & FVC and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).
- •daily unrestricted access to smartphone or tablet device at home.
- •demonstrated understanding of protocol and correct use of Spirobank Smart spirometer and patientMpower platform.
- •able and willing to perform spirometry every day at home.
- •willing to give written informed consent
排除标准
- •significant confusion or any concomitant medical condition which would limit the ability of the patient to record symptoms or use a home spirometer on a regular basis.
- •new prescription of antifibrotic therapy for IPF (e.g. pirfenidone, nintedanib) within 4 weeks before baseline visit.
- •recent exacerbation of IPF or other clinically significant change in the patient's medical condition in 4 weeks before baseline visit
研究组 & 干预措施
Observation sequence
Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks
干预措施: patientMpower platform (Other)
Observation sequence
Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks
干预措施: usual care (Other)
结局指标
主要结局
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
时间窗: single measurement at 8 weeks
Questionnaire-based assessment of response to questions: \[pMp = patientMpower platform\] 1. instructions for using pMp were clear 2. pMp helped me take the correct dose medicines 3. pMp helped me to take my medicines at the correct time 4. pMp helped me to reach my personal exercise goal 5. pMp helped me to walk further 6. pMp gave me a greater sense of control 7. useful to be able to record the impact of lung fibrosis on QoL 8. pMp encouraged me to look at the informational videos 9. preference for using pMp 10. difficulty in using pMp 11. effect of pMp on impact on daily life 12. tiring/irritating to use pMp 13. want to continue using pMp after study 14. would recommend pMp to others Possible responses Q1-8, Q12: strongly agree/agree/disagree/strongly disagree Q9: yes/no preference/no Q10: very easy/easy/difficult/very difficult Q11: positive/negative/open text Q13,14: yes/no
次要结局
- Patient-reported Forced Vital Capacity (FVC)(8 weeks)
- Patient-reported Exercise Performance(8 weeks)
- Medication Compliance (Days Medication Taken/Observation Period Days)(8 weeks)
- Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)(Baseline visit)