Remote Monitoring of Interstitial Lung Disease

Study Overview
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Brief Summary
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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.

Official Title
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Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment

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 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) demonstrates willingness to measure spirometry and pulse oximetry daily for the duration of the study fluent in English language Written informed consent. Exclusion Criteria: 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.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remote monitoring<br>Remote monitoring software + connected devices | Other: Remote monitoring<br>* patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of use ≥3 days/week | Proportion of patients recording measurements ≥3 days/week | 90 days | 
| Frequency of use on ≥70% of study days | Proportion of patients recording measurements on ≥70% of study days | 91 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | EuroQol 5-dimension 5-level (EQ-E5-DL) health status | 91 days | 
| Patient engagement | Patient Activation Measure | 91 days | 
| Change in Forced Vital Capacity (FVC) | Proportion of patients with ≥10% decreased FVC vs. baseline | 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 | 91 days | 
| Frequency of alert values of pulse oximetry SpO2 per patient | Number of pulse oximetry SpO2 <93% values per patient | 91 days | 
| Adherence to study measurements | Number of days patients record spirometry/number of days in observation period | 91 days | 
| Frequency of use ≥1 day/week | Proportion of patients recording measurements ≥1 day/week | 91 days | 
| Frequency of use ≥5 days/week | Proportion of patients recording measurements ≥5 days/week | 91 days |