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

NCT03104322 | Completed Results

• 1 other identifier: IPF patientMpower 02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

digital health; home spirometry; patient reported outcome measure; e-health; pirfenidone; nintedanib; FVC; antifibrotic

Outcome Measures

Primary Outcomes (1)

• Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective

  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

  single measurement at 8 weeks

Secondary Outcomes (4)

• Medication Compliance (Days Medication Taken/Observation Period Days)

  8 weeks

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

  Baseline visit

• Patient-reported Exercise Performance

  8 weeks

• Patient-reported Forced Vital Capacity (FVC)

  8 weeks

Study Arms (1)

Observation sequence

OTHER

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

Other: patientMpower platform; Other: usual care

Interventions

patientMpower platform OTHER

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

Observation sequence

usual care OTHER

usual care

Observation sequence

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• patientMpower Ltd.: lead
• Health Service Executive, Ireland: collaborator

Study Sites (1)

Dept. of Respiratory Medicine

Galway, Ireland

Location

Related 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

  BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: patientMpower

colin@patientmpower.com

+353872599131

Study Officials

• Dept. of Respiratory Medicine

  Galway University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 7, 2017
• Study Start: June 15, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: April 2, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)