Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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Single-arm, open-label observational study in idiopathic pulmonary fibrosis (IPF) patients receiving usual care at an interstitial lung disease specialist center. The objectives are [1] to characterise the longitudinal trends of patient-measured Forced Vital Capacity (FVC) and impact of IPF on daily life Patient Reported Outcome Measures (PROM) in a cohort of patients with IPF [2] to determine the correlation (if any) between patient-measured FVC and PROMs with clinic-observed measurements and [3] to assess if longitudinal trends in patient-measured FVC are predictive of clinical health outcomes in IPF. An additional purpose is to assess the acceptability and utility of the patientMpower app in helping IPF patients and their healthcare professional caregivers manage their condition. Patients will record FVC, symptoms (e.g. dyspnea) and activity (step count) daily and PROM once a week on the patientMpower app. The planned observation period is sixteen weeks. No additional clinic visits are required (versus usual care). In-clinic assessments of lung function, dyspnea and PROM will be done at baseline and study end. Patients and healthcare professionals will provide their opinion on utility and acceptability of patientMpower app at study end.

Detailed Description
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This is a single-arm, open-label observational study in IPF patients receiving usual care at an interstitial lung disease specialist centre. The objectives are [1] to characterise the longitudinal trends of patient-measured FVC and PROM in a cohort of patients with IPF [2] to determine the correlation (if any) between patient-measured FVC and PROMs with clinic-observed measurements and [3] to assess if longitudinal trends in patient-measured FVC are predictive of clinical health outcomes in IPF. An additional purpose is to assess the acceptability and utility of the patientMpower app in helping IPF patients and their healthcare professional caregivers manage their condition. This app has been specially developed for patients with lung fibrosis and is owned by patientMpower Ltd., Dublin, Ireland. The app is downloaded to the patient's mobile phone/tablet device. Patients can record symptoms (e.g. dyspnea), activity (steps/day) and lung function (FVC) via a Bluetooth-connected hand-held spirometer. The app can also be used to remind patients to take their medicines. The app includes a PROM to capture impact of IPF on daily life (once/week). This planned observation period is sixteen weeks. No additional clinic visits are required (compared with usual care). Only patients with a confirmed diagnosis of IPF who provide written informed consent will participate. At a usual care visit to the IPF clinic at the study centre, the research team will discuss the study with the patient (face-to-face) and seek written informed consent. The study starts at this visit (baseline). The IPF clinic will record the usual measurements which would be done at a routine visit to assess IPF. These will include FVC, assessment of dyspnea (modified Medical Research Council score) and PROM. After written informed consent, patientMpower Ltd. will send an information pack via e-mail and a Medical International Research Spirobank Smart spirometer to the patient. Technical support on installation of the app and spirometer will be provided by patientMpower Ltd. The patient will use the patientMpower app to record lung function, breathlessness, adherence to medication and symptoms every day at home until their next visit to the IPF clinic. Every week, patients will be reminded to record the impact of IPF on daily life PROM on the app. There will be no changes to the patient's usual care (e.g. prescribed medicines or exercises) during the study. After about sixteen weeks, patients will return to the IPF clinic for routine assessment of their IPF. The clinic will record all of the usual measurements as at baseline. Patients and healthcare professionals will provide their opinion on the utility and acceptability of the patientMpower app. The study is concluded at this visit. However, patients can continue to use the patientMpower app and spirometer if they wish.

Official Title
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An Observational Study of Self-monitoring of Spirometry and Symptoms Via the patientMpower App in Patients With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of idiopathic pulmonary fibrosis daily unrestricted access to smartphone/tablet device has an email address has home broadband or mobile data package demonstrates understanding of correct use of spirometer and patientMpower app able and willing to perform spirometry at home and record information on patientMpower app daily gives written informed consent Exclusion Criteria: significant confusion or any concomitant medical condition which would limit teh ability of the patient to record symptoms or use a home spirometer regularly new prescription of antifibrotic therapy for IPF (e.g. pirfenidone, nintedanib) within four weeks of baseline visit recent exacerbation of IPF or other clinically significant change in patient's medical condition in the four weeks before the baseline visit

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-measured Spirometry Trend Over Time | Mean patient-measured Forced Vital Capacity (FVC) in last seven days - FVC in first seven days after baseline | First 7 days at baseline and last 7 days in study up to 116 days | 
| Correlation Between Patient-measured and Clinic-measured Spirometry at Baseline | Bootstrap distribution of correlations analysis of patient-measured versus clinic-measured Forced Vital Capacity (FVC) at baseline calculated as follows. Means of first 7 days of patient-recorded FVC after baseline were calculated. (Patients without a single spirometry value in the 7-day window were excluded). Correlation between in-clinic FVC and patient-recorded FVC was calculated by randomly sampling from the data and calculating the Pearson correlation coefficient. This was repeated 1000 times, giving an empirical distribution for correlation (known as bootstrapping). The mean of this distribution is the inferred correlation. | First 7 days after baseline | 
| Correlation Between Patient-measured and Clinic-measured Spirometry at End of Study | Bootstrap distribution of correlations analysis of patient-measured versus clinic-measured Forced Vital Capacity (FVC) at end of study calculated as follows: Means of last 7 days of patient-recorded FVC after baseline were calculated. (Patients without a single spirometry value in the 7-day window were excluded). Correlation between in-clinic FVC and patient-recorded FVC was calculated by randomly sampling from the data and calculating the Pearson correlation coefficient. This was repeated 1000 times, giving an empirical distribution for correlation (known as bootstrapping). The mean of this distribution is the inferred correlation. | Last 7 days before end-of-study clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-clinic Patient Reported Outcome Measure at Start | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure. Combined score from 4 domains (psychological & physical impact of breathlessness, psychological well-being, fatigue). Values range: 1-4. Higher scores indicate worse outcome. Reported by patient at clinic. | Baseline | 
| In-clinic Patient Reported Outcome Measure at End | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure. Combined score from 4 domains (psychological & physical impact of breathlessness, psychological well-being, fatigue). Values range: 1-4. Higher scores indicate worse outcome. Reported by patient at clinic. | End-of-study (116 days) | 
| Patient-reported Patient Reported Outcome Measure at Start | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure. Combined score from 4 domains (psychological & physical impact of breathlessness, psychological well-being, fatigue). Values range: 1-4. Higher scores indicate worse outcome. Reported by patient at home. | Baseline | 
| Patient-reported Patient Reported Outcome Measure at End | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure; psychological & physical impact of breathlessness, psychological well-being, fatigue domains, values range 1-4, higher scores worse outcome. Reported by patients at home. | End-of-study (116 days) | 
| In-clinic Dyspnea Score at Start | modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4) | Baseline | 
| In-clinic Dyspnea Score at End | modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4) | 116 days | 
| Patient Opinion: Instructions Understandable? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: Helped me Take Correct Dose of Medicines? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: Helped me Achieve Exercise Goal? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: Helped me Walk Further? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: Using Application Gave me More Confidence? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: Useful to Measure Impact of Pulmonary Fibrosis on Daily Life? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: I Liked Using the Application? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: the Application Was Easy to Use? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: it Was Irritating to Use the Application? | Number of subjects responding strongly agree or agree shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | 
| Patient Opinion: Was the Effect of Application on Impact on Daily Life Positive? | Number of subjects responding yes. 2 possible responses: yes/no | 116 days | 
| Patient Opinion: I Want to Continue Using the Application? | Number of subjects responding yes. 2 possible responses: yes/no | 116 days | 
| Patient Opinion: I Would Recommend the Application to Others? | Number of subjects responding yes. 2 possible responses: yes/no | 116 days |