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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104322
• Other study ID #: IPF patientMpower 02
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: March 9, 2018

Study information

• Verified date: March 2019
• Source: patientMpower Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• patientMpower platform
electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms
• usual care
usual care

Locations

Country	Name	City	State
Ireland	Dept. of Respiratory Medicine	Galway

Sponsors (2)

Lead Sponsor	Collaborator
patientMpower Ltd.	Health Service Executive, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medication Compliance (Days Medication Taken/Observation Period Days)	Compliance recorded by patient via patientMpower platform daily	8 weeks
Secondary	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
Secondary	Patient-reported Exercise Performance	Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform	8 weeks
Secondary	Patient-reported Forced Vital Capacity (FVC)	Forced vital capacity recorded via patientMpower platform daily	8 weeks

External Links

•   American Thoracic Society 2018 poster abstract