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NCT Number: NCT05662124

ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basingstoke and North Hampshire Hospital, Basingstoke, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: patientMpower app

Primary outcomes

  1. Spirometry availability at clinical review at first and last clinic appointments during the study observation period

    Time frame: 12 months

    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

Secondary outcomes

  1. Number of clinical reviews per patient

    Time frame: 12 months

    Average for each study arm

  2. Proportion of clinical reviews which are virtual

    Time frame: 12 months

    Average for each study arm

  3. Number of in-clinic lung function appointments per patient

    Time frame: 12 months

    Total number for each study arm

  4. Number of patients who have chest CT scans

    Time frame: 12 months

    Total number for each study arm

  5. Change in forced vital capacity (FVC)

    Time frame: 12 months

    Average for each study arm

  6. Number of patients with >10% decline in FVC

    Time frame: 12 months

  7. Number of patients starting new treatments for their interstitial lung disease

    Time frame: 12 months

  8. Adherence to study measurements

    Time frame: 12 months

    Active study arm only, adherence calculated as number of days with recordings divded by 156 days, result will be an average.

  9. Number of patients recording measurements at least once/week on at least 66% study weeks

    Time frame: 12 months

    active study arm only.

  10. Number of unscheduled reviews per patient

    Time frame: 12 months

    Average for each study arm

  11. Number of hospital admissions per patient

    Time frame: 12 months

    Average for each study arm

  12. Change in patient recorded dyspnoea (mMRC) score

    Time frame: 12 months

    Average for each study arm

  13. Change in health-related quality of life (EQ-5D-5L) score

    Time frame: 12 months

    Average for each study arm

  14. Change in King's Brief Interstitial Lung Disease (K-BILD) score

    Time frame: 12 months

    Average for each study arm

  15. Change in Generalised Anxiety Disorder Assessment (GAD-7)

    Time frame: 12 months

    Average for each study arm

  16. Change in Patient Activation Measure (PAM-13)

    Time frame: 12 months

    Average for each study arm

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Collaborators

  • Action for Pulmonary Fibrosis
  • Imperial College London
  • University College, London
  • patientMpower Ltd.

Registry information

Official study title

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

Acronym: REMOTE-ILD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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