Trial Outcomes & Findings for Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis (NCT NCT03104322)

Last Updated: 2019-04-02

Results Overview

Questionnaire-based assessment of response to questions: \[pMp = patientMpower platform\] 1. instructions for using pMp were clear 2. pMp helped me take the correct dose medicines 3. pMp helped me to take my medicines at the correct time 4. pMp helped me to reach my personal exercise goal 5. pMp helped me to walk further 6. pMp gave me a greater sense of control 7. useful to be able to record the impact of lung fibrosis on QoL 8. pMp encouraged me to look at the informational videos 9. preference for using pMp 10. difficulty in using pMp 11. effect of pMp on impact on daily life 12. tiring/irritating to use pMp 13. want to continue using pMp after study 14. would recommend pMp to others Possible responses Q1-8, Q12: strongly agree/agree/disagree/strongly disagree Q9: yes/no preference/no Q10: very easy/easy/difficult/very difficult Q11: positive/negative/open text Q13,14: yes/no

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

single measurement at 8 weeks

Results posted on

2019-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observation Sequence n=7 Participants 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
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized white	7 Participants n=5 Participants
Region of Enrollment Ireland	7 participants n=5 Participants

PRIMARY outcome

Timeframe: single measurement at 8 weeks

Population: Patients who completed study and provided response to questionnaire

Outcome measures

Outcome measures
Measure	Observation Sequence n=4 Participants 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
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree instructions clear	3 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree helped correct dose of meds	1 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree helped time of meds	1 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree motivated re exercise	4 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree helped walk further	3 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree gave greater sense control	3 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree useful record impact on QoL	3 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree helped look at information videos	2 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective prefer using patientMpower	3 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective easy to use patientMpower	2 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective positive effect on impact on daily life	3 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective agree tiring/irritating to use patientMpower	0 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective want to continue after end study	4 Participants
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective would recommend to others	4 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Patients did not record medication compliance during study timeframe.

Compliance recorded by patient via patientMpower platform daily

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit

Population: patients who provided at least 1 IPF-PROM; insufficient data for analysis of time trends; Baseline values reported

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).

Outcome measures

Outcome measures
Measure	Observation Sequence n=2 Participants 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
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) Baseline overall quality of life	1.5 score on a scale Interval 1.0 to 2.0
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) Baseline psychological impact of dyspnoea	2.0 score on a scale Interval 1.3 to 2.7
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) Baseline physical impact of breathlessness	1.85 score on a scale Interval 1.0 to 2.7
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) Baseline psychological wellbeing	1.35 score on a scale Interval 1.0 to 1.7
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) Baseline energy	2.0 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 8 weeks

Population: No data available for analysis due to technical issues (no patient used a FitBit or mobile device with built-in accelerometer)

Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: All entered patients who provided home spirometry data

Forced vital capacity recorded via patientMpower platform daily

Outcome measures

Outcome measures
Measure	Observation Sequence n=7 Participants 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
Patient-reported Forced Vital Capacity (FVC) Baseline FVC (patient-reported)	2.40 L Interval 1.51 to 3.54
Patient-reported Forced Vital Capacity (FVC) 8-week FVC (patient-reported)	2.7 L Interval 2.2 to 3.8

Adverse Events

Observation Sequence

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Scientific Officer

patientMpower

Phone: +353872599131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place