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Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis

P

patientMpower

Status

Completed

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Other: patientMpower platform
Other: usual care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03104322
IPF patientMpower 02

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Observation sequence
Other group
Description:
Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks
Treatment:
Other: usual care
Other: patientMpower platform

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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