ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

Interstitial Lung Disease Clinical Trial

— REMOTE-ILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662124
• Other study ID #: 21SM6951
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: Sarah Barth
• Phone: +44 7435870022
• Email: imperial.ildmonitoring[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Remote monitoring
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.

Locations

Country	Name	City	State
United Kingdom	Basingstoke and North Hampshire Hospital	Basingstoke
United Kingdom	Royal Papworth Hospital	Cambridge
United Kingdom	Royal Devon University Healthcare NHS Trust	Exeter
United Kingdom	Leeds Teaching Hospital NHS Trust	Leeds
United Kingdom	University Hospital of Leicester NHS Trust	Leicester
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	St George's University Hospital NHS Foundation Trust	London
United Kingdom	Sheffield Teaching Hospitals NHS Trust	Sheffield
United Kingdom	Royal Hampshire County Hospital	Winchester

Sponsors (5)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	Action for Pulmonary Fibrosis, Imperial College London, patientMpower Ltd., University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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