Clinical trial NCT03104322: Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
Official title: A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: digital health
home spirometry
patient reported outcome measure
e-health
pirfenidone
nintedanib
FVC
antifibrotic
Lead sponsor: patientMpower Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Health Service Executive, Ireland
First posted: 2017-04-07
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
timeFrame: single measurement at 8 weeks
Secondary outcomes:
measure: Medication Compliance (Days Medication Taken/Observation Period Days)
timeFrame: 8 weeks
measure: Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)
timeFrame: Baseline visit
measure: Patient-reported Exercise Performance
timeFrame: 8 weeks
measure: Patient-reported Forced Vital Capacity (FVC)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Dept. of Respiratory Medicine
Study officials:
affiliation: Galway University Hospital
name: Dept. of Respiratory Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: S. Walsh, T. Cahill, C. Edwards, E. Costello, J. Walsh, A.-M. Russell, A.W. O'Regan. Patient-Reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis. American Journal of Respiratory and Critical Care Medicine 2018;197: A4933