ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care (REMOTE-ILD)

Imperial College Healthcare NHS Trust

Status: Active, not recruiting

Conditions: Interstitial Lung Disease

Treatments: Other: Remote monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05662124

21SM6951

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of fibrotic interstitial lung disease
• Aged at least 18 years
• Owns a smartphone or tablet device
• Has a mobile telephone number, email address and access to the internet at home
• In clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurement
• Intention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 months
• Willing to allow home monitoring of their health including spirometry and pulse oximetry data
• Understands 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 period
• Fluent in English language
• Written or electronic informed consent

Exclusion criteria

• Unable to fulfil all inclusion criteria
• Cognitive impairment
• History of difficulties performing spirometry at previous clinic testing
• Contraindications 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Remote Monitoring

Experimental group

Description:

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.

Treatment:

Other: Remote monitoring

Usual Care

No Intervention group

Description:

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.