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

NCT ID: NCT03744598

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-28
• Study Completion Date: 2020-04-30

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

patientMpower Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dept. of Respiratory Medicine

Dublin, , Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IPF patientMpower 03

Identifier Type: -

Identifier Source: org_study_id