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

A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: usual care; Other: patientMpower platform

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Dept. of Respiratory Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Observation sequence; Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks	Other: usual care; usual care; Other: patientMpower platform; electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective	Questionnaire-based assessment of response to questions: [pMp = patientMpower platform]; instructions for using pMp were clear; pMp helped me take the correct dose medicines; pMp helped me to take my medicines at the correct time; pMp helped me to reach my personal exercise goal; pMp helped me to walk further; pMp gave me a greater sense of control; useful to be able to record the impact of lung fibrosis on QoL; pMp encouraged me to look at the informational videos; preference for using pMp; difficulty in using pMp; effect of pMp on impact on daily life; tiring/irritating to use pMp; want to continue using pMp after study; would recommend pMp to others Possible responses Q1-8, Q12: strongly agree/agree/disagree/strongly disagree Q9: yes/no preference/no Q10: very easy/easy/difficult/very difficult Q11: positive/negative/open text Q13,14: yes/no	single measurement at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Compliance (Days Medication Taken/Observation Period Days)	Compliance recorded by patient via patientMpower platform daily	8 weeks
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)	12-item questionnaire with 4 domains (psychological experience of dyspnoea, physical experience of dyspnoea, emotional well-being, energy levels). 3 questions/domain asking frequency of symptom or its impact in the time interval since last response. Four possible responses to each question: none of the time/some of the time/most of the time/all of the time. Numerical score assigned to each response 1/2/3/4 (respectively). Impact on domain characterised by mean score for each of 3 questions in that domain. One question on overall quality of life with responses: excellent/good/fair/poor/very poor. Numerical score assigned to each response 1/2/3/4/5 respectively. Low score better outcome; high score worse outcome (for all responses).	Baseline visit
Patient-reported Exercise Performance	Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform	8 weeks
Patient-reported Forced Vital Capacity (FVC)	Forced vital capacity recorded via patientMpower platform daily	8 weeks

Collaborators and Investigators

• Sponsor: patientMpower Ltd.
• Collaborators: Health Service Executive, Ireland
• Investigators: Principal Investigator: Dept. of Respiratory Medicine, Galway University Hospital

Publications and helpful links

General Publications

• 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

Helpful Links

• American Thoracic Society 2018 poster abstract

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2017
• Primary Completion (ACTUAL): March 9, 2018
• Study Completion (ACTUAL): March 9, 2018

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: digital health; patient reported outcome measure; e-health; FVC; pirfenidone; home spirometry; nintedanib; antifibrotic
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: IPF patientMpower 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No