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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Other: patientMpower platform
* Other: usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observation sequence<br>Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks | Other: patientMpower platform<br>* electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms<br>Other: usual care<br>* usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | Questionnaire-based assessment of response to questions: [pMp = patientMpower platform] instructions for using pMp were clear pMp helped me take the correct dose medicines pMp helped me to take my medicines at the correct time pMp helped me to reach my personal exercise goal pMp helped me to walk further pMp gave me a greater sense of control useful to be able to record the impact of lung fibrosis on QoL pMp encouraged me to look at the informational videos preference for using pMp difficulty in using pMp effect of pMp on impact on daily life tiring/irritating to use pMp want to continue using pMp after study 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 | single measurement at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Compliance (Days Medication Taken/Observation Period Days) | Compliance recorded by patient via patientMpower platform daily | 8 weeks | 
| Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) | 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). | Baseline visit | 
| Patient-reported Exercise Performance | Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform | 8 weeks | 
| Patient-reported Forced Vital Capacity (FVC) | Forced vital capacity recorded via patientMpower platform daily | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital health, home spirometry, patient reported outcome measure, e-health, pirfenidone, nintedanib, FVC, antifibrotic