An interventional study of Remote monitoring in Interstitial Lung Disease, sponsored by Imperial College Healthcare NHS Trust. Active, not recruiting at 12 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Imperial College Healthcare NHS Trust · Not applicable, Interventional, and Other
Interstitial lung disease (ILD) is a collective term for a group of diseases where the lungs become scarred causing breathlessness.
This research project will assess if remote digital monitoring of frequent spirometry and pulse oximetry can provide an additional way to monitor ILD and provide information to support virtual consultations. Outcomes in the remote monitoring group will be compared with usual care alone over 12 months.
Patients taking part will be randomly allocated to remote digital monitoring or to usual care (with an equal chance of either). Remote monitoring will be performed using an app provided by patientMpower Ltd which patients will be able to download onto a smartphone or tablet. The study team will provide a spirometer and oximeter for patients to measure their lung function (spirometry) and oxygen saturations. These devices link to the app via Bluetooth to record all measurements. Patients will be asked to do these measurements three times a week. Clinical teams will be asked to review all measurements at least once a fortnight.
Health outcomes will be described and compared between the two groups.
This study hopes to understand more about how remote digital monitoring of spirometry and pulse oximetry fits within the clinical care of patients with interstitial lung disease. This study will randomise patients to either remote monitoring or usual care and then collect information about the trajectory of their interstitial lung disease treatment and monitoring for the next 12 months to understand the impact of remote monitoring.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 139 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will be asked to record their spirometry and oximetry three times weekly. This will be performed using a spirometer and oximeter which upload the results via bluetooth to the patientMpower app on their smartphones/tablets. These results are immediately available for review by their clinical teams who will be asked to review them at least once a fortnight. All patients will be asked to complete surveys at baseline, 3, 6, and 12 months and for clinical outcome data during the observation period to be collected.
Other: Remote monitoring
Patients in this arm will undergo usual clinical care as planned by their medical team. They will be asked to complete surveys at baseline, 3,6 and 12 months and for clinical outcome data during the observation period to be collected.
Patients will download the patientMpower app and be provided with a spirometer (Spirobank Smart, MIR) and oximeter (Nonin) to record their spirometry and pulse oximetry which will upload to the application via Bluetooth for clinical review. Patients will be asked to upload measurements three times per week.
Also known as: patientMpower app
Spirometry availability at clinical review at first and last clinic appointments during the study observation period
Number of patients who have spirometry recorded with the preceding 2 weeks for review at the first and last clinical reviews during the observation period
Time frame: 12 months
Number of clinical reviews per patient
Average for each study arm
Time frame: 12 months
Proportion of clinical reviews which are virtual
Average for each study arm
Time frame: 12 months
Number of in-clinic lung function appointments per patient
Total number for each study arm
Time frame: 12 months
Number of patients who have chest CT scans
Total number for each study arm
Time frame: 12 months
Change in forced vital capacity (FVC)
Average for each study arm
Time frame: 12 months
Number of patients with >10% decline in FVC
Time frame: 12 months
Number of patients starting new treatments for their interstitial lung disease
Time frame: 12 months
Adherence to study measurements
Active study arm only, adherence calculated as number of days with recordings divded by 156 days, result will be an average.
Time frame: 12 months
Number of patients recording measurements at least once/week on at least 66% study weeks
active study arm only.
Time frame: 12 months
Number of unscheduled reviews per patient
Average for each study arm
Time frame: 12 months
Number of hospital admissions per patient
Average for each study arm
Time frame: 12 months
Change in patient recorded dyspnoea (mMRC) score
Average for each study arm
Time frame: 12 months
Change in health-related quality of life (EQ-5D-5L) score
Average for each study arm
Time frame: 12 months
Change in King's Brief Interstitial Lung Disease (K-BILD) score
Average for each study arm
Time frame: 12 months
Change in Generalised Anxiety Disorder Assessment (GAD-7)
Average for each study arm
Time frame: 12 months
Change in Patient Activation Measure (PAM-13)
Average for each study arm
Time frame: 12 months
Plan to share: No — Aggregate participant data will be available to shared with other researchers only.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Imperial College Healthcare NHS Trust