Idiopathic Pulmonary Fibrosis
Conditions
Keywords
digital health, home spirometry, patient reported outcome measure, e-health, pirfenidone, nintedanib, FVC, antifibrotic
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.
Interventions
OTHERpatientMpower platform
electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms
OTHERusual care
usual care
Sponsors
Health Service Executive, Ireland
patientMpower Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | 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
| Measure | Time frame | Description |
|---|---|---|
| Medication Compliance (Days Medication Taken/Observation Period Days) | 8 weeks | Compliance recorded by patient via patientMpower platform daily |
| Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) | 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). |
| Patient-reported Exercise Performance | 8 weeks | Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform |
| Patient-reported Forced Vital Capacity (FVC) | 8 weeks | Forced vital capacity recorded via patientMpower platform daily |
Countries
Ireland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observation Sequence Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks
patientMpower platform: electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms
usual care: usual care | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Observation Sequence |
|---|---|
| Age, Continuous | 69 years |
| Race/Ethnicity, Customized white | 7 Participants |
| Region of Enrollment Ireland | 7 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
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
Population: Patients who completed study and provided response to questionnaire
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree instructions clear | 3 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree helped correct dose of meds | 1 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree helped time of meds | 1 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree motivated re exercise | 4 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree helped walk further | 3 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree gave greater sense control | 3 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree useful record impact on QoL | 3 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree helped look at information videos | 2 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | prefer using patientMpower | 3 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | easy to use patientMpower | 2 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | positive effect on impact on daily life | 3 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | agree tiring/irritating to use patientMpower | 0 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | want to continue after end study | 4 Participants |
| Observation Sequence | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | would recommend to others | 4 Participants |
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).
Time frame: Baseline visit
Population: patients who provided at least 1 IPF-PROM; insufficient data for analysis of time trends; Baseline values reported
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Observation Sequence | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) | Baseline overall quality of life | 1.5 score on a scale |
| Observation Sequence | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) | Baseline psychological impact of dyspnoea | 2.0 score on a scale |
| Observation Sequence | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) | Baseline physical impact of breathlessness | 1.85 score on a scale |
| Observation Sequence | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) | Baseline psychological wellbeing | 1.35 score on a scale |
| Observation Sequence | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) | Baseline energy | 2.0 score on a scale |
Secondary
Medication Compliance (Days Medication Taken/Observation Period Days)
Compliance recorded by patient via patientMpower platform daily
Time frame: 8 weeks
Population: Patients did not record medication compliance during study timeframe.
Secondary
Patient-reported Exercise Performance
Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Time frame: 8 weeks
Population: No data available for analysis due to technical issues (no patient used a FitBit or mobile device with built-in accelerometer)
Secondary
Patient-reported Forced Vital Capacity (FVC)
Forced vital capacity recorded via patientMpower platform daily
Time frame: 8 weeks
Population: All entered patients who provided home spirometry data
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Observation Sequence | Patient-reported Forced Vital Capacity (FVC) | Baseline FVC (patient-reported) | 2.40 L |
| Observation Sequence | Patient-reported Forced Vital Capacity (FVC) | 8-week FVC (patient-reported) | 2.7 L |