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Completed

NCT Number: NCT03104322

Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in 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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Respiratory Medicine

Galway, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patientMpower platform

Other

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

Usual Care

Other

usual care

Primary outcomes

  1. Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective

    Time frame: single measurement at 8 weeks

    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

Secondary outcomes

  1. Medication Compliance (Days Medication Taken/Observation Period Days)

    Time frame: 8 weeks

    Compliance recorded by patient via patientMpower platform daily

  2. Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)

    Time frame: Baseline visit

    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).

  3. Patient-reported Exercise Performance

    Time frame: 8 weeks

    Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform

  4. Patient-reported Forced Vital Capacity (FVC)

    Time frame: 8 weeks

    Forced vital capacity recorded via patientMpower platform daily

Sponsors and collaborators

Lead sponsor

patientMpower Ltd.

Industry

Collaborators

  • Health Service Executive, Ireland

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2017
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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