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Not Yet Recruiting NCT07844915

Artificial Intelligence Enhanced Remote Monitoring in Interstitial Lung Disease

Conditions: Fibrotic Interstitial Lung Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: King's College London

Location: King's College London London

Summary

The goal of this clinical trial is to learn whether artificial intelligence AI-enhanced remote monitoring (AIRM) is feasible, safe and acceptable for adults with fibrotic interstitial lung disease (fILD). The artificial intelligence (AI) system uses information collected through home monitoring to identify patterns that may suggest a person's lung condition is getting worse. The AI does not make treatment decisions. Its outputs are reviewed by healthcare professionals. The main questions this study aims to answer are: Is AIRM feasible and acceptable for people with fILD and their healthcare professionals? Can it be used safely to help identify possible worsening of fILD? How well does the AI system identify clinical deterioration? Participants will take part for about 12 months. They will: Measure their lung function and oxygen levels at home each week using connected monitoring devices. Report their breathlessness and cough symptoms each week using the patientMpower app. Complete questionnaires about their health and their experience of remote monitoring at the start of the study and every 3 months. Continue to receive their usual clinical care. Some participants will also be invited to an interview or focus group to discuss their experience of AI-enhanced remote monitoring. Healthcare professionals involved in the study may also be invited to discuss their experience of using the system. The AI system is investigational and is being evaluated as part of this study. Healthcare professionals will review relevant AI-generated alerts before taking any clinical action. The AI will support, rather than replace, clinical judgement.

Eligibility Criteria

Inclusion Criteria: * Aged 18 years or older. * Diagnosis of fibrotic interstitial lung disease (fILD) confirmed through multidisciplinary team review at a tertiary ILD centre, based on high-resolution computed tomography (HRCT) and standard clinical assessment. * Forced vital capacity (FVC) \>45% predicted. * Able to perform spirometry and use a home spirometer safely and reliably. * Availability of baseline pulmonary function tests (PFTs), preferably within the preceding 6 months as part of routine clinical care. * Access to a compatible smart device with internet connectivity. * Able to understand study procedures, communicate with the research team, and complete study questionnaires and remote monitoring tasks. * Has capacity to provide informed consent. Exclusion Criteria: * Previous participation in the REMILD study. * Estimated life expectancy of less than 6 months, as judged by the treating clinician. * Contraindication to spirometry in accordance with Association for Respiratory Technology and Physiology (ARTP) guidelines. * Current or recent acute exacerbation of ILD, confirmed clinically and/or radiologically, within the previous 4 weeks. * Active or life-limiting malignancy that, in the opinion of the treating clinician, is likely to affect participation, adherence to study procedures, or interpretation of study outcomes.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07844915). StuddyBuddy aggregates publicly available trial information.