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

NCT03744598 | Terminated Results

• 1 other identifier: IPF patientMpower 03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• In-clinic Patient Reported Outcome Measure at Start

  Baseline

• In-clinic Patient Reported Outcome Measure at End

  End-of-study (116 days)

• Patient-reported Patient Reported Outcome Measure at Start

  Baseline

• Patient-reported Patient Reported Outcome Measure at End

  End-of-study (116 days)

• In-clinic Dyspnea Score at Start

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with idiopathic pulmonary fibrosis attending a specialist outpatient interstitial lung disease clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• patientMpower Ltd.: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Dept. of Respiratory Medicine

Dublin, D07 R2WY, Ireland

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: patientMpower Ltd

colin@patientmpower.com

353872599131

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: November 28, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 28, 2022
• Results First Posted: July 22, 2022

Record last verified: 2022-07

Locations

IE (1)