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

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ClinicalTrials.gov Identifier: NCT03104322
Recruitment Status : Completed
First Posted : April 7, 2017
Results First Posted : January 23, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Health Service Executive, Ireland
Information provided by (Responsible Party):
patientMpower Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Other: patientMpower platform Other: usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine


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

Other: usual care
usual care


Outcome Measures
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Primary Outcome Measures :
  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]

    1. instructions for using pMp were clear
    2. pMp helped me take the correct dose medicines
    3. pMp helped me to take my medicines at the correct time
    4. pMp helped me to reach my personal exercise goal
    5. pMp helped me to walk further
    6. pMp gave me a greater sense of control
    7. useful to be able to record the impact of lung fibrosis on QoL
    8. pMp encouraged me to look at the informational videos
    9. preference for using pMp
    10. difficulty in using pMp
    11. effect of pMp on impact on daily life
    12. tiring/irritating to use pMp
    13. want to continue using pMp after study
    14. 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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104322


Locations
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Ireland
Dept. of Respiratory Medicine
Galway, Ireland
Sponsors and Collaborators
patientMpower Ltd.
Health Service Executive, Ireland
Investigators
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Principal Investigator: Dept. of Respiratory Medicine Galway University Hospital
  Study Documents (Full-Text)

Documents provided by patientMpower Ltd.:
Study Protocol and Statistical Analysis Plan  [PDF] July 12, 2017

More Information
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Additional Information:

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

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Responsible Party: patientMpower Ltd.
ClinicalTrials.gov Identifier: NCT03104322    
Other Study ID Numbers: IPF patientMpower 02
First Posted: April 7, 2017    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by patientMpower Ltd.:
digital health
home spirometry
patient reported outcome measure
e-health
 pirfenidone
nintedanib
FVC
antifibrotic
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases