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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
7
electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms
usual care
Dept. of Respiratory Medicine
Galway, Ireland
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
Time frame: single measurement at 8 weeks
Medication Compliance (Days Medication Taken/Observation Period Days)
Compliance recorded by patient via patientMpower platform daily
Time frame: 8 weeks
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).
Time frame: Baseline visit
Patient-reported Exercise Performance
Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Time frame: 8 weeks
Patient-reported Forced Vital Capacity (FVC)
Forced vital capacity recorded via patientMpower platform daily
Time frame: 8 weeks
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