Trial Outcomes & Findings for Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis (NCT NCT03744598)

Results Overview

Mean patient-measured Forced Vital Capacity (FVC) in last seven days - FVC in first seven days after baseline

Recruitment status

TERMINATED

Target enrollment

20 participants

Primary outcome timeframe

First 7 days at baseline and last 7 days in study up to 116 days

Results posted on

2022-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Treated All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once. All patients received usual care throughout (i.e. no changes to care mandated by protocol.)
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated n=20 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
Age, Continuous	66.6 years STANDARD_DEVIATION 9.02 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Ireland	20 participants n=5 Participants
In-clinic Forced Vital Capacity (absolute)	3.30 Litres STANDARD_DEVIATION 0.74 • n=5 Participants
In-clinic Forced Vital Capacity (percent predicted)	92 percent predicted STANDARD_DEVIATION 17 • n=5 Participants

PRIMARY outcome

Timeframe: First 7 days at baseline and last 7 days in study up to 116 days

Mean patient-measured Forced Vital Capacity (FVC) in last seven days - FVC in first seven days after baseline

Outcome measures

Outcome measures
Measure	Treated n=20 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
Patient-measured Spirometry Trend Over Time	-0.035 litre Standard Deviation 0.490

PRIMARY outcome

Timeframe: First 7 days after baseline

Population: Patients in treated dataset for whom data were available in 7 days after 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.

Outcome measures

Outcome measures
Measure	Treated n=9 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
Correlation Between Patient-measured and Clinic-measured Spirometry at Baseline	0.72 Distribution of correlation coefficient Standard Deviation 0.02

PRIMARY outcome

Timeframe: Last 7 days before end-of-study clinic visit

Population: Patients in treated dataset for whom data were available in the 7 days before 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.

Outcome measures

Outcome measures
Measure	Treated n=13 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
Correlation Between Patient-measured and Clinic-measured Spirometry at End of Study	0.77 Distribution of correlation coefficient Standard Deviation 0.01

SECONDARY outcome

Timeframe: Baseline

Population: Patients reporting outcomes at beginning

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.

Outcome measures

Outcome measures
Measure	Treated n=20 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
In-clinic Patient Reported Outcome Measure at Start	1.76 score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: End-of-study (116 days)

Population: Patients reporting outcomes 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.

Outcome measures

Outcome measures
Measure	Treated n=17 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
In-clinic Patient Reported Outcome Measure at End	1.78 score on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: Baseline

Population: Patients reporting outcome measure at home (not available for all subjects entered)

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.

Outcome measures

Outcome measures
Measure	Treated n=10 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
Patient-reported Patient Reported Outcome Measure at Start	1.60 score on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: End-of-study (116 days)

Population: Patients reporting outcome measure at home (not available for all subjects entered)

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.

Outcome measures

Outcome measures
Measure	Treated n=9 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
Patient-reported Patient Reported Outcome Measure at End	1.79 score on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Baseline

modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4)

Outcome measures

Outcome measures
Measure	Treated n=20 Participants All patients who gave informed consent, downloaded the patientMpower application and used the patientMpower application with a MIR Spirobank Smart spirometer at least once.
In-clinic Dyspnea Score at Start	2 score on a scale Interval 1.75 to 2.25

SECONDARY outcome

Timeframe: 116 days

modified Medical Research Council dyspnea score (range 0-4; worst dyspnea = 4)