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| Name | Class |
|---|---|
| Health Service Executive, Ireland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation sequence | Other | Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patientMpower platform | Other | electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | Questionnaire-based assessment of response to questions: [pMp = patientMpower platform]
| single measurement at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Compliance (Days Medication Taken/Observation Period Days) | Compliance recorded by patient via patientMpower platform daily | 8 weeks |
| Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dept. of Respiratory Medicine | Galway University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Respiratory Medicine | Galway | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective | Questionnaire-based assessment of response to questions: [pMp = patientMpower platform]
| Patients who completed study and provided response to questionnaire | Posted | Count of Participants | Participants | single measurement at 8 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | patientMpower | +353872599131 | colin@patientmpower.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2017 | Aug 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
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| usual care | Other | usual care |
|
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 |
| Patient-reported Exercise Performance | Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform | 8 weeks |
| Patient-reported Forced Vital Capacity (FVC) | Forced vital capacity recorded via patientMpower platform daily | 8 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Description |
|---|
| OG000 | 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 |
|
|
| Secondary | Medication Compliance (Days Medication Taken/Observation Period Days) | Compliance recorded by patient via patientMpower platform daily | Patients did not record medication compliance during study timeframe. | Posted | 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). | patients who provided at least 1 IPF-PROM; insufficient data for analysis of time trends; Baseline values reported | Posted | Mean | Full Range | score on a scale | Baseline visit |
|
|
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| Secondary | Patient-reported Exercise Performance | Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform | No data available for analysis due to technical issues (no patient used a FitBit or mobile device with built-in accelerometer) | Posted | 8 weeks |
|
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| Secondary | Patient-reported Forced Vital Capacity (FVC) | Forced vital capacity recorded via patientMpower platform daily | All entered patients who provided home spirometry data | Posted | Mean | Full Range | L | 8 weeks |
|
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| Baseline psychological wellbeing |
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| Baseline energy |
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