Idiopathic Pulmonary FibrosisNCT03104322
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
A study testing patientMpower platform in people with Idiopathic Pulmonary Fibrosis, run by patientMpower Ltd. at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- patientMpower platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIreland
- Study dates
- 15 Jun 2017to 9 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- patientMpower platform, usual care
- Keywords
- digital health, home spirometry, patient reported outcome measure, e-health, pirfenidone, nintedanib, FVC, antifibrotic
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patientMpower platformOther
electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms
usual careOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| Observation sequence | Other | Period 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks Receives: Other: patientMpower platform; Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
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
Measured: single measurement at 8 weeks
Secondary outcomes (4)
Medication Compliance (Days Medication Taken/Observation Period Days)
Compliance recorded by patient via patientMpower platform daily
Measured: 8 weeks
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)
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).
Measured: Baseline visit
Patient-reported Exercise Performance
Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform
Measured: 8 weeks
Patient-reported Forced Vital Capacity (FVC)
Forced vital capacity recorded via patientMpower platform daily
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start15 Jun 2017
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- patientMpower Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Service Executive, Ireland
- Responsible party
- Sponsor
- Investigators
- Dept. of Respiratory Medicine, Principal investigator, Galway University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104322
- Sponsor's protocol ID
- IPF patientMpower 02
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2017
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Crossover Study of Self-monitoring of Symptoms and Spirometry Via the patientMpower Platform in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03104322
- Acronym / sponsor ID
- IPF patientMpower 02
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- digital health, home spirometry, patient reported outcome measure, e-health, pirfenidone, nintedanib, FVC, antifibrotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- patientMpower Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Health Service Executive, Ireland
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed-order, two-period crossover (2 x 8 weeks), no washout, usual care controlled
| Arm | Type | Receives |
|---|---|---|
| Observation sequence | Other | Other: patientMpower platform, Other: usual carePeriod 1: patientMpower platform+usual care for 8 weeks; Period 2: usual care alone for 8 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patientMpower platformelectronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms | Other | Observation sequence |
| usual careusual care | Other | Observation sequence |
Primary outcome
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective
Time frame: single measurement at 8 weeks
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
4 secondary outcomes
Medication Compliance (Days Medication Taken/Observation Period Days)
Time frame: 8 weeks
Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)
Time frame: Baseline visit
Patient-reported Exercise Performance
Time frame: 8 weeks
Patient-reported Forced Vital Capacity (FVC)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundS. 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept. of Respiratory Medicine principal investigator
Galway University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patientMpower platform in people with Idiopathic Pulmonary Fibrosis, run by patientMpower Ltd. at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective (time frame: single measurement at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.