Interstitial Lung DiseaseNCT04850521
Remote Monitoring of Interstitial Lung Disease
An observational study of Interstitial Lung Disease, run by patientMpower Ltd. at 4 sites in United Kingdom.
Trial summary
As in-clinic pulmonary function testing is greatly restricted due to Coronavirus Disease 2019 (COVID19), alternative approaches to monitoring patients with long-term respiratory conditions need to be developed and assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Remote monitoring
- How many people
- 60 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 3 Aug 2021to 7 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of interstitial lung disease (including idiopathic pulmonary fibrosis)
Who may be able to join
- diagnosis of interstitial lung disease
- Forced Vital Capacity ≥50% predicted (at most recent in-clinic spirometry test)
- owns a smartphone or tablet device
- has a mobile telephone number, email address and access to internet at home
- willing to allow home monitoring of their health including spirometry and pulse oximetry data
- understands how to use mobile technology (e.g. has downloaded and used other "apps" on their mobile device; uses email)
Show all 9Show fewer
- demonstrates willingness to measure spirometry and pulse oximetry daily for the duration of the study
- fluent in English language
- Written informed consent.
Who cannot join
- serious concomitant conditions which place the patient at high risk of respiratory distress, making them unsuitable to be managed at home
- confusion which would limit the patient's understanding of the project or the measurement procedures
- current or recent (within last 6 weeks before baseline) participation in another clinical research project.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Hampshire Hospitals NHS Foundation Trust
Basingstoke
Imperial College NHS Healthcare Trust
London
Nottingham University Hospitals NHS Trust
Nottingham
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
About this study
Official title: Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment
As in-clinic pulmonary function testing is greatly restricted due to Coronavirus Disease 2019 (COVID19), alternative approaches to monitoring patients with long-term respiratory conditions need to be developed and assessed. This project will evaluate the feasibility of a remote monitoring programme designed for interstitial lung disease (ILD) [including idiopathic pulmonary fibrosis (IPF)] patients which includes patient-reported spirometry \& pulse oximetry (to estimate lung airflow and oxygen levels in the blood).
Patients with a confirmed diagnosis of ILD will be asked to measure spirometry \& pulse oximetry once/day for approximately three months. Each patient will be supplied with a spirometer \& pulse oximeter for home use. There will be no other changes to patients' care. The clinical teams responsible for care of the patients will be able to view all patient-recorded data immediately after data are recorded by the patient. Feasibility of remote monitoring will be assessed by determining the proportion of patients who provide measurements at least 3 times/week and on at least 70% of days in the observation period. Patient engagement (Patient Activation Measure), changes in spirometry measurements over time and healthcare resource utilisation (e.g. number of in-clinic visits) will also be assessed. Other outcomes assessed will include estimation of the proportion of patients with significant decreases in lung function, number of occasions where critical alert values of physiological parameters are reported and number of interventions by healthcare professionals in response to observations or alerts from remote monitoring. Feedback from patients and healthcare providers on user experience will also be sought.
Learnings from this project will be used to assess the wider application of delivery of digitally-based remote monitoring in management of long-term respiratory conditions.
- Conditions
- Interstitial Lung Disease
- Being tested
- Remote monitoring
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoringOther
patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring | Remote monitoring software + connected devices Receives: Other: Remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of use ≥3 days/week
Proportion of patients recording measurements ≥3 days/week
Measured: 90 days
Frequency of use on ≥70% of study days
Proportion of patients recording measurements on ≥70% of study days
Measured: 91 days
Secondary outcomes (8)
Health-related quality of life
EuroQol 5-dimension 5-level (EQ-E5-DL) health status
Measured: 91 days
Patient engagement
Patient Activation Measure
Measured: 91 days
Change in Forced Vital Capacity (FVC)
Proportion of patients with ≥10% decreased FVC vs. baseline
Measured: 91 days
Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)
Proportion of patients with pulse oximetry SpO2 <93% at any time
Measured: 91 days
Frequency of alert values of pulse oximetry SpO2 per patient
Number of pulse oximetry SpO2 <93% values per patient
Measured: 91 days
Adherence to study measurements
Number of days patients record spirometry/number of days in observation period
Measured: 91 days
Frequency of use ≥1 day/week
Proportion of patients recording measurements ≥1 day/week
Measured: 91 days
Frequency of use ≥5 days/week
Proportion of patients recording measurements ≥5 days/week
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start3 Aug 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- patientMpower Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quiddity Health Ltd., Innovate UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850521
- Sponsor's protocol ID
- ILD patientMpower 01
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barth S, Edwards C, Saini G, Haider Y, Williams NP, Storrar W, Jenkins G, Stewart I, Wickremasinghe M. Feasibility and acceptability of remotely monitoring spirometry and pulse oximetry as part of interstitial lung disease clinical care: a single arm observational study. Respir Res. 2024 Apr 15;25(1):162. doi: 10.1186/s12931-024-02787-1.
PubMed 38622608
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment
- ClinicalTrials.gov ID
- NCT04850521
- Acronym / sponsor ID
- ILD patientMpower 01
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- patientMpower Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quiddity Health Ltd., Innovate UK
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As in-clinic pulmonary function testing is greatly restricted due to Coronavirus Disease 2019 (COVID19), alternative approaches to monitoring patients with long-term respiratory conditions need to be developed and assessed. This project will evaluate the feasibility of a remote monitoring programme designed for interstitial lung disease (ILD) [including idiopathic pulmonary fibrosis (IPF)] patients which includes patient-reported spirometry \& pulse oximetry (to estimate lung airflow and oxygen levels in the blood).
Patients with a confirmed diagnosis of ILD will be asked to measure spirometry \& pulse oximetry once/day for approximately three months. Each patient will be supplied with a spirometer \& pulse oximeter for home use. There will be no other changes to patients' care. The clinical teams responsible for care of the patients will be able to view all patient-recorded data immediately after data are recorded by the patient. Feasibility of remote monitoring will be assessed by determining the proportion of patients who provide measurements at least 3 times/week and on at least 70% of days in the observation period. Patient engagement (Patient Activation Measure), changes in spirometry measurements over time and healthcare resource utilisation (e.g. number of in-clinic visits) will also be assessed. Other outcomes assessed will include estimation of the proportion of patients with significant decreases in lung function, number of occasions where critical alert values of physiological parameters are reported and number of interventions by healthcare professionals in response to observations or alerts from remote monitoring. Feedback from patients and healthcare providers on user experience will also be sought.
Learnings from this project will be used to assess the wider application of delivery of digitally-based remote monitoring in management of long-term respiratory conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote monitoring | – | Other: Remote monitoringRemote monitoring software + connected devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of interstitial lung disease (including idiopathic pulmonary fibrosis)
Key inclusion criteria (9 listed)
- diagnosis of interstitial lung disease
- Forced Vital Capacity ≥50% predicted (at most recent in-clinic spirometry test)
- owns a smartphone or tablet device
- has a mobile telephone number, email address and access to internet at home
- willing to allow home monitoring of their health including spirometry and pulse oximetry data
Key exclusion criteria (3 listed)
- serious concomitant conditions which place the patient at high risk of respiratory distress, making them unsuitable to be managed at home
- confusion which would limit the patient's understanding of the project or the measurement procedures
- current or recent (within last 6 weeks before baseline) participation in another clinical research project.
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 |
|---|---|---|
| Remote monitoringpatient-facing app + connected spirometer + connected pulse oximeter + clinician view portal | Other | Remote monitoring |
Primary outcome
Frequency of use ≥3 days/week
Time frame: 90 days
Proportion of patients recording measurements ≥3 days/week
Frequency of use on ≥70% of study days
Time frame: 91 days
Proportion of patients recording measurements on ≥70% of study days
8 secondary outcomes
Health-related quality of life
Time frame: 91 days
Patient engagement
Time frame: 91 days
Change in Forced Vital Capacity (FVC)
Time frame: 91 days
Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)
Time frame: 91 days
Frequency of alert values of pulse oximetry SpO2 per patient
Time frame: 91 days
Adherence to study measurements
Time frame: 91 days
Frequency of use ≥1 day/week
Time frame: 91 days
Frequency of use ≥5 days/week
Time frame: 91 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Derived from this study: PubMed 38622608Barth S, Edwards C, Saini G, Haider Y, Williams NP, Storrar W, Jenkins G, Stewart I, Wickremasinghe M. Feasibility and acceptability of remotely monitoring spirometry and pulse oximetry as part of interstitial lung disease clinical care: a single arm observational study. Respir Res. 2024 Apr 15;25(1):162. doi: 10.1186/s12931-024-02787-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by patientMpower Ltd. at 4 sites in United Kingdom.
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 9 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of use ≥3 days/week (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT04850521, 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 12 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.