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ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

Study acronym: REMOTE-ILD
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 21, 2024 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 132 to confirmed 139
    • Study sites: 11 to 12
    • Primary completion date: Jan 2025 to Mar 2025
    v8
  2. Notable Primary endpoint revised
    • Study sites: 4 to 11
    • Secondary endpoints: 11 to 16
    v7
  3. Minor Study sites: 3 to 4
    • Primary completion date: Jul 2024 to Jan 2025
    • Study completion date: Jul 2024 to Apr 2025
    v6
  4. Minor Study sites: 1 to 3v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2023 to Mar 7, 2023
    • Site details revised
    v4
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  1. Notable Start date: Jan 2023 to Apr 2023v3
  2. Minor Eligibility criteria revisedv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05662124
Lead Sponsor Imperial College Healthcare NHS Trust
Collaborators: patientMpower Ltd., Imperial College London, University College, London, Action for Pulmonary Fibrosis
Conditions
(from sponsor)
Interstitial Lung Disease
Related terms Lung Diseases, Interstitial
Enrollment 139 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov