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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: Remote monitoring

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Basingstoke, United Kingdom
    • Basingstoke and North Hampshire Hospital
  • Cambridge, United Kingdom
    • Royal Papworth Hospital
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon University Healthcare NHS Trust
  • Leeds, United Kingdom
    • Leeds Teaching Hospital NHS Trust
  • Leicester, United Kingdom
    • University Hospital of Leicester NHS Trust
  • Liverpool, United Kingdom
    • Liverpool University Hospitals NHS Foundation Trust
  • London, United Kingdom
    • Royal Brompton Hospital
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom
    • St George's University Hospital NHS Foundation Trust
  • Sheffield, United Kingdom
    • Sheffield Teaching Hospitals NHS Trust
  • Winchester, United Kingdom
    • Royal Hampshire County Hospital
  • Wolverhampton, United Kingdom
    • New Cross Hospital, Royal Wolverhampton NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Monitoring; 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; 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.; Other Names: patientMpower app
No Intervention: Usual Care; 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?

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 patients with >10% decline in FVC		12 months
Number of patients starting new treatments for their interstitial lung disease		12 months
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
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

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Collaborators: Imperial College London; University College, London; patientMpower Ltd.; Action for Pulmonary Fibrosis
• Investigators: Principal Investigator: Melissa Wickremasinghe, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 21SM6951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate participant data will be available to shared with other researchers only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No