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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
patientMpower platform
usual care
Sponsored by
patientMpower Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Pulmonary Fibrosis focused on measuring digital health, home spirometry, patient reported outcome measure, e-health, pirfenidone, nintedanib, FVC, antifibrotic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept. of Respiratory Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Observation sequence

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Medication Compliance (Days Medication Taken/Observation Period Days)
Compliance recorded by patient via patientMpower platform daily
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).
Patient-reported Exercise Performance
Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Patient-reported Forced Vital Capacity (FVC)
Forced vital capacity recorded via patientMpower platform daily

Full Information

First Posted
March 27, 2017
Last Updated
March 19, 2019
Sponsor
patientMpower Ltd.
Collaborators
Health Service Executive, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT03104322
Brief Title
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
Official Title
A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
patientMpower Ltd.
Collaborators
Health Service Executive, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
digital health, home spirometry, patient reported outcome measure, e-health, pirfenidone, nintedanib, FVC, antifibrotic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation sequence
Arm Type
Other
Arm Description
Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks
Intervention Type
Other
Intervention Name(s)
patientMpower platform
Intervention Description
electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
usual care
Primary Outcome Measure Information:
Title
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
Description
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
Time Frame
single measurement at 8 weeks
Secondary Outcome Measure Information:
Title
Medication Compliance (Days Medication Taken/Observation Period Days)
Description
Compliance recorded by patient via patientMpower platform daily
Time Frame
8 weeks
Title
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)
Description
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).
Time Frame
Baseline visit
Title
Patient-reported Exercise Performance
Description
Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Time Frame
8 weeks
Title
Patient-reported Forced Vital Capacity (FVC)
Description
Forced vital capacity recorded via patientMpower platform daily
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dept. of Respiratory Medicine
Organizational Affiliation
Galway University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Respiratory Medicine
City
Galway
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
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Learn more about this trial

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

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