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

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ClinicalTrials.gov Identifier: NCT03104322
Recruitment Status : Completed
First Posted : April 7, 2017
Results First Posted : January 23, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Health Service Executive, Ireland
Information provided by (Responsible Party):
patientMpower Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Idiopathic Pulmonary Fibrosis
Interventions Other: patientMpower platform
Other: usual care
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Observation Sequence
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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
Arm/Group Title Observation Sequence
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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 Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants
69
(57 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
1
  14.3%
Male
6
  85.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
white Number Analyzed 7 participants
7
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Ireland Number Analyzed 7 participants
7
1.Primary Outcome
Title Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
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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
Time Frame single measurement at 8 weeks
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Hide Analysis Population Description
Patients who completed study and provided response to questionnaire
Arm/Group Title Observation Sequence
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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 Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
agree instructions clear
3
  75.0%
agree helped correct dose of meds
1
  25.0%
agree helped time of meds
1
  25.0%
agree motivated re exercise
4
 100.0%
agree helped walk further
3
  75.0%
agree gave greater sense control
3
  75.0%
agree useful record impact on QoL
3
  75.0%
agree helped look at information videos
2
  50.0%
prefer using patientMpower
3
  75.0%
easy to use patientMpower
2
  50.0%
positive effect on impact on daily life
3
  75.0%
agree tiring/irritating to use patientMpower
0
   0.0%
want to continue after end study
4
 100.0%
would recommend to others
4
 100.0%
2.Secondary Outcome
Title Medication Compliance (Days Medication Taken/Observation Period Days)
Hide Description Compliance recorded by patient via patientMpower platform daily
Time Frame 8 weeks
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Patients did not record medication compliance during study timeframe.
Arm/Group Title Observation Sequence
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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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)
Hide 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
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Hide 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
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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 Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: score on a scale
Baseline overall quality of life
1.5
(1 to 2)
Baseline psychological impact of dyspnoea
2.0
(1.3 to 2.7)
Baseline physical impact of breathlessness
1.85
(1.0 to 2.7)
Baseline psychological wellbeing
1.35
(1.0 to 1.7)
Baseline energy
2.0
(1.0 to 2.0)
4.Secondary Outcome
Title Patient-reported Exercise Performance
Hide Description Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Time Frame 8 weeks
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Hide 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
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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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Patient-reported Forced Vital Capacity (FVC)
Hide Description Forced vital capacity recorded via patientMpower platform daily
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All entered patients who provided home spirometry data
Arm/Group Title Observation Sequence
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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 Number of Participants Analyzed 7
Mean (Full Range)
Unit of Measure: L
Baseline FVC (patient-reported) Number Analyzed 7 participants
2.40
(1.51 to 3.54)
8-week FVC (patient-reported) Number Analyzed 6 participants
2.7
(2.2 to 3.8)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Observation Sequence
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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 (%)
Total   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Observation Sequence
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Observation Sequence
Affected / at Risk (%)
Total   0/7 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: patientMpower
Phone: +353872599131
EMail: colin@patientmpower.com
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
Layout table for additonal information
Responsible Party: patientMpower Ltd.
ClinicalTrials.gov Identifier: NCT03104322     History of Changes
Other Study ID Numbers: IPF patientMpower 02
First Submitted: March 27, 2017
First Posted: April 7, 2017
Results First Submitted: August 1, 2018
Results First Posted: January 23, 2019
Last Update Posted: April 2, 2019