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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03104322 |
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Date of registration:
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27/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
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Scientific title:
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A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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June 15, 2017 |
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Target sample size:
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7 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03104322 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Dept. of Respiratory Medicine |
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Address:
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Telephone:
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Email:
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Affiliation:
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Galway University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Other: patientMpower platform
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Other: usual care
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Primary Outcome(s)
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Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
[Time Frame: single measurement at 8 weeks]
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Secondary Outcome(s)
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Patient-reported Forced Vital Capacity (FVC)
[Time Frame: 8 weeks]
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Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)
[Time Frame: Baseline visit]
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Medication Compliance (Days Medication Taken/Observation Period Days)
[Time Frame: 8 weeks]
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Patient-reported Exercise Performance
[Time Frame: 8 weeks]
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Secondary ID(s)
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IPF patientMpower 02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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