Clinical trial NCT03744598: Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis
Official title: An Observational Study of Self-monitoring of Spirometry and Symptoms Via the patientMpower App in Patients With Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: patientMpower Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2018-11-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic pulmonary fibrosis attending a specialist outpatient interstitial lung disease clinic.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-measured Spirometry Trend Over Time
timeFrame: First 7 days at baseline and last 7 days in study up to 116 days
measure: Correlation Between Patient-measured and Clinic-measured Spirometry at Baseline
timeFrame: First 7 days after baseline
measure: Correlation Between Patient-measured and Clinic-measured Spirometry at End of Study
timeFrame: Last 7 days before end-of-study clinic visit
Secondary outcomes:
measure: In-clinic Patient Reported Outcome Measure at Start
timeFrame: Baseline
measure: In-clinic Patient Reported Outcome Measure at End
timeFrame: End-of-study (116 days)
measure: Patient-reported Patient Reported Outcome Measure at Start
timeFrame: Baseline
measure: Patient-reported Patient Reported Outcome Measure at End
timeFrame: End-of-study (116 days)
measure: In-clinic Dyspnea Score at Start
timeFrame: Baseline
measure: In-clinic Dyspnea Score at End
timeFrame: 116 days
measure: Patient Opinion: Instructions Understandable?
timeFrame: 116 days
measure: Patient Opinion: Helped me Take Correct Dose of Medicines?
timeFrame: 116 days
measure: Patient Opinion: Helped me Achieve Exercise Goal?
timeFrame: 116 days
measure: Patient Opinion: Helped me Walk Further?
timeFrame: 116 days
measure: Patient Opinion: Using Application Gave me More Confidence?
timeFrame: 116 days
measure: Patient Opinion: Useful to Measure Impact of Pulmonary Fibrosis on Daily Life?
timeFrame: 116 days
measure: Patient Opinion: I Liked Using the Application?
timeFrame: 116 days
measure: Patient Opinion: the Application Was Easy to Use?
timeFrame: 116 days
measure: Patient Opinion: it Was Irritating to Use the Application?
timeFrame: 116 days
measure: Patient Opinion: Was the Effect of Application on Impact on Daily Life Positive?
timeFrame: 116 days
measure: Patient Opinion: I Want to Continue Using the Application?
timeFrame: 116 days
measure: Patient Opinion: I Would Recommend the Application to Others?
timeFrame: 116 days
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Dept. of Respiratory Medicine
Study officials:
References: