N/A
N=7
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03104322 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective — 3; 1; 1; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- patientMpower platform (Other); usual care (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- patientMpower Ltd.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective |
3; 1; 1; 4; 3; 3 | — |
| SECONDARY Medication Compliance (Days Medication Taken/Observation Period Days) |
— | — |
| SECONDARY Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) |
1.5; 2.0; 1.85; 1.35; 2.0 | — |
| SECONDARY Patient-reported Exercise Performance |
— | — |
| SECONDARY Patient-reported Forced Vital Capacity (FVC) |
2.40; 2.7 | — |
Summary
Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced vital capacity (FVC; daily), impact of IPF on daily life (weekly) and other symptoms. Objectives are to characterise acceptability of patientMpower platform from patient & healthcare professional perspective, impact of active engagement and self-monitoring using patientMpower platform on Patient Reported Outcome Measures (PROMs) in IPF, impact of patientMpower platform on medication compliance and correlation between patient-reported PROMs & FVC and clinical outcomes.
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).
- daily unrestricted access to smartphone or tablet device at home.
- demonstrated understanding of protocol and correct use of Spirobank Smart spirometer and patientMpower platform.
- able and willing to perform spirometry every day at home.
- willing to give written informed consent
Exclusion Criteria
- significant confusion or any concomitant medical condition which would limit the ability of the patient to record symptoms or use a home spirometer on a regular basis.
- new prescription of antifibrotic therapy for IPF (e.g. pirfenidone, nintedanib) within 4 weeks before baseline visit.
- recent exacerbation of IPF or other clinically significant change in the patient's medical condition in 4 weeks before baseline visit
Data sourced from ClinicalTrials.gov (NCT03104322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.