ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

NCT05662124 | Active Not Recruiting

• 1 other identifier: 21SM6951
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Number of clinical reviews per patient

  12 months

• Proportion of clinical reviews which are virtual

  12 months

• Number of in-clinic lung function appointments per patient

  12 months

• Number of patients who have chest CT scans

  12 months

• Change in forced vital capacity (FVC)

  12 months

Study Arms (2)

Remote Monitoring

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Remote monitoring OTHER

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.

Also known as: patientMpower app

Remote Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• patientMpower Ltd.: collaborator
• Imperial College London: collaborator
• University College, London: collaborator
• Action for Pulmonary Fibrosis: collaborator

Study Sites (12)

Basingstoke and North Hampshire Hospital

Basingstoke, United Kingdom

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

Royal Devon University Healthcare NHS Trust

Exeter, EX2 5DW, United Kingdom

Location

Leeds Teaching Hospital NHS Trust

Leeds, United Kingdom

Location

University Hospital of Leicester NHS Trust

Leicester, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

St George's University Hospital NHS Foundation Trust

London, United Kingdom

Location

Sheffield Teaching Hospitals NHS Trust

Sheffield, United Kingdom

Location

Royal Hampshire County Hospital

Winchester, United Kingdom

Location

New Cross Hospital, Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Melissa Wickremasinghe

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: March 7, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)