Outcome
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 |
|