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ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05662124
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Imperial College Healthcare NHS Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Melissa Wickremasinghe
Principal Investigator Affiliation	Imperial College Healthcare NHS Trust
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.