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NCT05662124
ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care
Conditions: Interstitial Lung Disease
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 132
Sponsor: Imperial College Healthcare NHS Trust
Location: United Kingdom
Summary
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.
Eligibility Criteria
Inclusion Criteria:Diagnosis of fibrotic interstitial lung diseaseAged at least 18 yearsOwns a smartphone or tablet deviceHas a mobile telephone number, email address and access to the internet at homeIn clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurementIntention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 monthsWilling to allow home monitoring of their health including spirometry and pulse oximetry dataUnderstands how to use mobile technology (eg.
has downloaded and used other "apps" on their mobile device; uses email)Demonstrates willingness to measure spirometry and pulse oximetry three times weekly for the duration of the observation periodFluent in English languageWritten or electronic informed consentExclusion Criteria:Unable to fulfil all inclusion criteriaCognitive impairmentHistory of difficulties performing spirometry at previous clinic testingContraindications to spirometry (for example previous pneumothorax, unstable cardiac status, known aortic or cerebral aneurysm)Serious concomitant conditions which place the patient at high risk of respiratory distress making them unsuitable to be managed at home.Current or recent (within the last 6 weeks before baseline) participation in another research project
Source: ClinicalTrials.gov (NCT05662124). StuddyBuddy aggregates publicly available trial information.