Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Observation sequence	patientMpower platform	Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks
Observation sequence	usual care	Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks

Primary Outcome Measures

Name	Time	Method
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective	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

Secondary Outcome Measures

Name	Time	Method
Patient-reported Forced Vital Capacity (FVC)	8 weeks	Forced vital capacity recorded via patientMpower platform daily
Patient-reported Exercise Performance	8 weeks	Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Medication Compliance (Days Medication Taken/Observation Period Days)	8 weeks	Compliance recorded by patient via patientMpower platform daily
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)	Baseline visit	12-item questionnaire with 4 domains (psychological experience of dyspnoea, physical experience of dyspnoea, emotional well-being, energy levels). 3 questions/domain asking frequency of symptom or its impact in the time interval since last response. Four possible responses to each question: none of the time/some of the time/most of the time/all of the time. Numerical score assigned to each response 1/2/3/4 (respectively). Impact on domain characterised by mean score for each of 3 questions in that domain. One question on overall quality of life with responses: excellent/good/fair/poor/very poor. Numerical score assigned to each response 1/2/3/4/5 respectively. Low score better outcome; high score worse outcome (for all responses).