Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
An Observational Study of Self-monitoring of Spirometry and Symptoms Via the patientMpower App in Patients With Idiopathic Pulmonary Fibrosis
Verified date | July 2022 |
Source | patientMpower Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Single-arm, open-label observational study in idiopathic pulmonary fibrosis (IPF) patients receiving usual care at an interstitial lung disease specialist center. The objectives are [1] to characterise the longitudinal trends of patient-measured Forced Vital Capacity (FVC) and impact of IPF on daily life Patient Reported Outcome Measures (PROM) in a cohort of patients with IPF [2] to determine the correlation (if any) between patient-measured FVC and PROMs with clinic-observed measurements and [3] to assess if longitudinal trends in patient-measured FVC are predictive of clinical health outcomes in IPF. An additional purpose is to assess the acceptability and utility of the patientMpower app in helping IPF patients and their healthcare professional caregivers manage their condition. Patients will record FVC, symptoms (e.g. dyspnea) and activity (step count) daily and PROM once a week on the patientMpower app. The planned observation period is sixteen weeks. No additional clinic visits are required (versus usual care). In-clinic assessments of lung function, dyspnea and PROM will be done at baseline and study end. Patients and healthcare professionals will provide their opinion on utility and acceptability of patientMpower app at study end.
Status | Terminated |
Enrollment | 20 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - confirmed diagnosis of idiopathic pulmonary fibrosis - daily unrestricted access to smartphone/tablet device - has an email address - has home broadband or mobile data package - demonstrates understanding of correct use of spirometer and patientMpower app - able and willing to perform spirometry at home and record information on patientMpower app daily - gives written informed consent Exclusion Criteria: - significant confusion or any concomitant medical condition which would limit teh ability of the patient to record symptoms or use a home spirometer regularly - new prescription of antifibrotic therapy for IPF (e.g. pirfenidone, nintedanib) within four weeks of baseline visit - recent exacerbation of IPF or other clinically significant change in patient's medical condition in the four weeks before the baseline visit |
Country | Name | City | State |
---|---|---|---|
Ireland | Dept. of Respiratory Medicine | Dublin |
Lead Sponsor | Collaborator |
---|---|
patientMpower Ltd. | Boehringer Ingelheim |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-measured Spirometry Trend Over Time | Mean patient-measured Forced Vital Capacity (FVC) in last seven days - FVC in first seven days after baseline | First 7 days at baseline and last 7 days in study up to 116 days | |
Primary | Correlation Between Patient-measured and Clinic-measured Spirometry at Baseline | Bootstrap distribution of correlations analysis of patient-measured versus clinic-measured Forced Vital Capacity (FVC) at baseline calculated as follows. Means of first 7 days of patient-recorded FVC after baseline were calculated. (Patients without a single spirometry value in the 7-day window were excluded). Correlation between in-clinic FVC and patient-recorded FVC was calculated by randomly sampling from the data and calculating the Pearson correlation coefficient. This was repeated 1000 times, giving an empirical distribution for correlation (known as bootstrapping). The mean of this distribution is the inferred correlation. | First 7 days after baseline | |
Primary | Correlation Between Patient-measured and Clinic-measured Spirometry at End of Study | Bootstrap distribution of correlations analysis of patient-measured versus clinic-measured Forced Vital Capacity (FVC) at end of study calculated as follows: Means of last 7 days of patient-recorded FVC after baseline were calculated. (Patients without a single spirometry value in the 7-day window were excluded). Correlation between in-clinic FVC and patient-recorded FVC was calculated by randomly sampling from the data and calculating the Pearson correlation coefficient. This was repeated 1000 times, giving an empirical distribution for correlation (known as bootstrapping). The mean of this distribution is the inferred correlation. | Last 7 days before end-of-study clinic visit | |
Secondary | In-clinic Patient Reported Outcome Measure at Start | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure. Combined score from 4 domains (psychological & physical impact of breathlessness, psychological well-being, fatigue). Values range: 1-4. Higher scores indicate worse outcome. Reported by patient at clinic. | Baseline | |
Secondary | In-clinic Patient Reported Outcome Measure at End | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure. Combined score from 4 domains (psychological & physical impact of breathlessness, psychological well-being, fatigue). Values range: 1-4. Higher scores indicate worse outcome. Reported by patient at clinic. | End-of-study (116 days) | |
Secondary | Patient-reported Patient Reported Outcome Measure at Start | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure. Combined score from 4 domains (psychological & physical impact of breathlessness, psychological well-being, fatigue). Values range: 1-4. Higher scores indicate worse outcome. Reported by patient at home. | Baseline | |
Secondary | Patient-reported Patient Reported Outcome Measure at End | Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure; psychological & physical impact of breathlessness, psychological well-being, fatigue domains, values range 1-4, higher scores worse outcome. Reported by patients at home. | End-of-study (116 days) | |
Secondary | In-clinic Dyspnea Score at Start | modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4) | Baseline | |
Secondary | In-clinic Dyspnea Score at End | modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4) | 116 days | |
Secondary | Patient Opinion: Instructions Understandable? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: Helped me Take Correct Dose of Medicines? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: Helped me Achieve Exercise Goal? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: Helped me Walk Further? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: Using Application Gave me More Confidence? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: Useful to Measure Impact of Pulmonary Fibrosis on Daily Life? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: I Liked Using the Application? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: the Application Was Easy to Use? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: it Was Irritating to Use the Application? | Number of subjects responding "strongly agree" or "agree" shown. 4 possible responses: strongly agree/agree/disagree/strongly disagree; | 116 days | |
Secondary | Patient Opinion: Was the Effect of Application on Impact on Daily Life Positive? | Number of subjects responding "yes". 2 possible responses: yes/no | 116 days | |
Secondary | Patient Opinion: I Want to Continue Using the Application? | Number of subjects responding "yes". 2 possible responses: yes/no | 116 days | |
Secondary | Patient Opinion: I Would Recommend the Application to Others? | Number of subjects responding "yes". 2 possible responses: yes/no | 116 days |
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