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

Terminated

Conditions: Idiopathic Pulmonary Fibrosis

Registration Number: NCT03744598

Lead Sponsor: patientMpower Ltd.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation Between Patient-measured and Clinic-measured Spirometry at Baseline	First 7 days after 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.
Patient-measured Spirometry Trend Over Time	First 7 days at baseline and last 7 days in study up to 116 days	Mean patient-measured Forced Vital Capacity (FVC) in last seven days - FVC in first seven days after baseline
Correlation Between Patient-measured and Clinic-measured Spirometry at End of Study	Last 7 days before end-of-study clinic visit	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.

Secondary Outcome Measures

Name	Time	Method
Patient Opinion: Useful to Measure Impact of Pulmonary Fibrosis on Daily Life?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: I Liked Using the Application?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: the Application Was Easy to Use?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
In-clinic Patient Reported Outcome Measure at Start	Baseline	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.
In-clinic Patient Reported Outcome Measure at End	End-of-study (116 days)	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.
Patient-reported Patient Reported Outcome Measure at Start	Baseline	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.
Patient-reported Patient Reported Outcome Measure at End	End-of-study (116 days)	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.
In-clinic Dyspnea Score at End	116 days	modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4)
In-clinic Dyspnea Score at Start	Baseline	modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4)
Patient Opinion: Instructions Understandable?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: Helped me Achieve Exercise Goal?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: it Was Irritating to Use the Application?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: Was the Effect of Application on Impact on Daily Life Positive?	116 days	Number of subjects responding "yes". 2 possible responses: yes/no
Patient Opinion: I Would Recommend the Application to Others?	116 days	Number of subjects responding "yes". 2 possible responses: yes/no
Patient Opinion: Helped me Take Correct Dose of Medicines?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: Helped me Walk Further?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: Using Application Gave me More Confidence?	116 days	Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree;
Patient Opinion: I Want to Continue Using the Application?	116 days	Number of subjects responding "yes". 2 possible responses: yes/no