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

• Sponsor: patientMpower Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03104322
• Collaborator: Health Service Executive, Ireland (Other)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced vital capacity (FVC; daily), impact of IPF on daily life (weekly) and other symptoms. Objectives are to characterise acceptability of patientMpower platform from patient & healthcare professional perspective, impact of active engagement and self-monitoring using patientMpower platform on Patient Reported Outcome Measures (PROMs) in IPF, impact of patientMpower platform on medication compliance and correlation between patient-reported PROMs & FVC and clinical outcomes.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Other: patientMpower platform; Other: usual care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlledFixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis
• Actual Study Start Date: Jun 15, 2017
• Actual Primary Completion Date: Mar 9, 2018
• Actual Study Completion Date: Mar 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Observation sequence Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks	Other: patientMpower platform; electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms; Other: usual care; usual care

Outcome Measures

Primary Outcome Measures

1. Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective [single measurement at 8 weeks]

   Questionnaire-based assessment of response to questions: [pMp = patientMpower platform] instructions for using pMp were clear pMp helped me take the correct dose medicines pMp helped me to take my medicines at the correct time pMp helped me to reach my personal exercise goal pMp helped me to walk further pMp gave me a greater sense of control useful to be able to record the impact of lung fibrosis on QoL pMp encouraged me to look at the informational videos preference for using pMp difficulty in using pMp effect of pMp on impact on daily life tiring/irritating to use pMp want to continue using pMp after study 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

Secondary Outcome Measures

1. Medication Compliance (Days Medication Taken/Observation Period Days) [8 weeks]

   Compliance recorded by patient via patientMpower platform daily

2. Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM) [Baseline visit]

   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).

3. Patient-reported Exercise Performance [8 weeks]

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

4. Patient-reported Forced Vital Capacity (FVC) [8 weeks]

   Forced vital capacity recorded via patientMpower platform daily

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Respiratory Medicine	Galway		Ireland

Sponsors and Collaborators

• patientMpower Ltd.
• Health Service Executive, Ireland

Investigators

• Principal Investigator: Dept. of Respiratory Medicine, Galway University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 12, 2017

More Information

Additional Information:

• American Thoracic Society 2018 poster abstract

Publications

• S. Walsh, T. Cahill, C. Edwards, E. Costello, J. Walsh, A.-M. Russell, A.W. O'Regan. Patient-Reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis. American Journal of Respiratory and Critical Care Medicine 2018;197: A4933

• Responsible Party: patientMpower Ltd.
• ClinicalTrials.gov Identifier: NCT03104322
• Other Study ID Numbers: IPF patientMpower 02
• First Posted: Apr 7, 2017
• Last Update Posted: Apr 2, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by patientMpower Ltd.: digital health; home spirometry; patient reported outcome measure; e-health; pirfenidone; nintedanib; FVC; antifibrotic
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

Participant Flow

Arm/Group Title	Observation Sequence
Arm/Group Description	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
Period Title: Overall Study
STARTED	7
COMPLETED	6
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Observation Sequence
Arm/Group Description	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 Participants	7
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	69
Sex: Female, Male (Count of Participants)
Female	1 14.3%
Male	6 85.7%
Race/Ethnicity, Customized (Count of Participants)
white	7 100%
Region of Enrollment (participants) [Number]
Ireland	7 100%

Outcome Measures

1. Primary Outcome

Title	Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
Description	Questionnaire-based assessment of response to questions: [pMp = patientMpower platform] instructions for using pMp were clear pMp helped me take the correct dose medicines pMp helped me to take my medicines at the correct time pMp helped me to reach my personal exercise goal pMp helped me to walk further pMp gave me a greater sense of control useful to be able to record the impact of lung fibrosis on QoL pMp encouraged me to look at the informational videos preference for using pMp difficulty in using pMp effect of pMp on impact on daily life tiring/irritating to use pMp want to continue using pMp after study 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
Time Frame	single measurement at 8 weeks

Outcome Measure Data

Analysis Population Description

Patients who completed study and provided response to questionnaire

Arm/Group Title	Observation Sequence
Arm/Group Description	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
Measure Participants	4
agree instructions clear	3 42.9%
agree helped correct dose of meds	1 14.3%
agree helped time of meds	1 14.3%
agree motivated re exercise	4 57.1%
agree helped walk further	3 42.9%
agree gave greater sense control	3 42.9%
agree useful record impact on QoL	3 42.9%
agree helped look at information videos	2 28.6%
prefer using patientMpower	3 42.9%
easy to use patientMpower	2 28.6%
positive effect on impact on daily life	3 42.9%
agree tiring/irritating to use patientMpower	0 0%
want to continue after end study	4 57.1%
would recommend to others	4 57.1%

2. Secondary Outcome

Title	Medication Compliance (Days Medication Taken/Observation Period Days)
Description	Compliance recorded by patient via patientMpower platform daily
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Patients did not record medication compliance during study timeframe.

Arm/Group Title	Observation Sequence
Arm/Group Description	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
Measure Participants	0

3. Secondary Outcome

Title	Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)
Description	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).
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Observation Sequence
Arm/Group Description	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
Measure Participants	2
Baseline overall quality of life	1.5
Baseline psychological impact of dyspnoea	2.0
Baseline physical impact of breathlessness	1.85
Baseline psychological wellbeing	1.35
Baseline energy	2.0

4. Secondary Outcome

Title	Patient-reported Exercise Performance
Description	Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Observation Sequence
Arm/Group Description	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
Measure Participants	0

5. Secondary Outcome

Title	Patient-reported Forced Vital Capacity (FVC)
Description	Forced vital capacity recorded via patientMpower platform daily
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All entered patients who provided home spirometry data

Arm/Group Title	Observation Sequence
Arm/Group Description	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
Measure Participants	7
Baseline FVC (patient-reported)	2.40
8-week FVC (patient-reported)	2.7

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Observation Sequence
Arm/Group Description	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
All Cause Mortality
	Observation Sequence
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Serious Adverse Events
	Observation Sequence
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Observation Sequence
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.