ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Health Outcomes in a Remote Monitoring Programme Versus Usual Care in Interstitial Lung Disease

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Other: Remote monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Monitoring<br>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<br>* 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.<br>* Other names: patientMpower app;|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical reviews per patient | Average for each study arm | 12 months | 
| Proportion of clinical reviews which are virtual | Average for each study arm | 12 months | 
| Number of in-clinic lung function appointments per patient | Total number for each study arm | 12 months | 
| Number of patients who have chest CT scans | Total number for each study arm | 12 months | 
| Change in forced vital capacity (FVC) | Average for each study arm | 12 months | 
| Number of patients with >10% decline in FVC |  | 12 months | 
| Number of patients starting new treatments for their interstitial lung disease |  | 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. | 12 months | 
| Number of patients recording measurements at least once/week on at least 66% study weeks | active study arm only. | 12 months | 
| Number of unscheduled reviews per patient | Average for each study arm | 12 months | 
| Number of hospital admissions per patient | Average for each study arm | 12 months | 
| Change in patient recorded dyspnoea (mMRC) score | Average for each study arm | 12 months | 
| Change in health-related quality of life (EQ-5D-5L) score | Average for each study arm | 12 months | 
| Change in King's Brief Interstitial Lung Disease (K-BILD) score | Average for each study arm | 12 months | 
| Change in Generalised Anxiety Disorder Assessment (GAD-7) | Average for each study arm | 12 months | 
| Change in Patient Activation Measure (PAM-13) | Average for each study arm | 12 months |