ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Remote Monitoring of Interstitial Lung Disease

NCT04850521

Interstitial Lung Disease

COMPLETED

PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT

NCT05609201

Interstitial Lung Disease

ENROLLING_BY_INVITATION

The UK Interstitial Lung Disease Long-COVID19 Study (UKILD-Long COVID): Understanding the Burden of Interstitial Lung Disease in Long COVID.

NCT05514522

Interstitial Lung Disease SARS-CoV-2 Infection

RECRUITING

Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)

NCT05998512

Interstitial Lung Disease Interstitial Fibrosis

RECRUITING

FIBRotic Interstitial Lung Disease and Nocturnal OXygen

NCT04586946

Idiopathic Pulmonary Fibrosis Obstructive Sleep Apnea Sleep Disturbance +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interstitial Lung Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Remote monitoring

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

patientMpower app

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No