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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2018-03-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Observation sequence

Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks

Group Type OTHER

patientMpower platform

Intervention Type OTHER

electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms

usual care

Intervention Type OTHER

usual care

Interventions

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patientMpower platform

electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms

Intervention Type OTHER

usual care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No