A Mixed-Methods Feasibility Study Evaluating Artificial Intelligence Enhanced Remote Monitoring in Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recruitment Rate of Eligible Participants
研究概览
简要总结
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.
详细描述
AIRMILD is a prospective, single-arm, mixed-methods feasibility study evaluating artificial intelligence-enhanced remote monitoring (AIRM) in people with fibrotic interstitial lung disease (fILD). Approximately 120 participants will be recruited from the interstitial lung disease (ILD) service at Guy's and St Thomas' NHS Foundation Trust (GSTT).
The study will evaluate AIRM version 1.0, an investigational artificial intelligence (AI) algorithm integrated within the patientMpower remote monitoring platform. AIRM analyses longitudinal multimodal remote monitoring data, including home spirometry, pulse oximetry, symptom scores and patient-reported measures, to identify patterns associated with potential clinical deterioration.
AIRM is intended to support clinical review rather than replace clinical assessment or clinical decision-making. It will not make autonomous diagnoses or treatment decisions. AIRM-generated outputs that may contribute to clinical management will be reviewed by an appropriately qualified clinician before clinical action is taken. Clinicians will retain independent clinical oversight and responsibility for clinical decisions. Participants will continue to receive usual clinical care throughout the study.
AIRM version 1.0 is investigational and is not UKCA or CE marked. The prediction algorithm will be fixed before prospective evaluation and will not be retrained or modified during participant follow-up. This will allow the performance of the predefined model to be evaluated prospectively against clinically identified deterioration.
The study will assess the feasibility of delivering an AIRM pathway in clinical practice, including participant engagement with remote monitoring and the practical integration of AI-generated information into clinical review. Safety evaluation will include assessment of situations in which AIRM generates an alert without subsequent clinical deterioration and situations in which clinical deterioration occurs without a preceding AIRM alert. The study will also evaluate the performance of AIRM in identifying potential clinical deterioration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AI-enhanced remote monitoring pathway
Participants will receive AI-enhanced remote monitoring (AIRM) for 12 months using the patientMpower platform. Participants will undertake home spirometry and pulse oximetry, report symptoms, and complete patient-reported measures. AIRM version 1.0, an investigational artificial intelligence (AI) algorithm, will analyse longitudinal remote monitoring data to identify patterns associated with potential clinical deterioration. AIRM-generated outputs that may contribute to clinical management will be reviewed by an appropriately qualified clinician before any clinical action is taken. AIRM will support, rather than replace, clinical judgement, and participants will continue to receive usual clinical care.
干预措施: AIRM v1.0 AI-Enhanced Remote Monitoring (Device)
结局指标
主要结局
Recruitment Rate of Eligible Participants
时间窗: Up to 24 weeks
Recruitment rate will be calculated as the number of eligible individuals who provide informed consent and enrol in the study divided by the total number of eligible individuals approached for participation, multiplied by 100. The outcome will be reported as a percentage.
Percentage of Enrolled Participants Retained at 12 Months
时间窗: Up to 12 months
Retention rate will be calculated as the number of enrolled participants who remain enrolled in the study through to the end of the 12-month active remote monitoring period divided by the total number of participants enrolled, multiplied by 100. The outcome will be reported as a percentage.
Percentage of Weekly Home Spirometry Measurements Completed
时间窗: Up to 52 weeks
Calculated as the number of scheduled weekly home spirometry measurements completed by participants divided by the total number of scheduled home spirometry measurements, multiplied by 100.
Percentage of Scheduled Pulse Oximetry Measurements Completed
时间窗: Up to 52 weeks
Calculated as the number of scheduled weekly pulse oximetry measurements completed by participants divided by the total number of scheduled pulse oximetry measurements, multiplied by 100.
Percentage of Scheduled Weekly Cough Assessments Completed (Cough Visual Analogue Scale)
时间窗: Up to 52 weeks
Calculated as the number of scheduled weekly Cough Visual Analogue Scale assessments completed by participants divided by the total number of scheduled Cough Visual Analogue Scale assessments, multiplied by 100. The Cough Visual Analogue Scale assesses cough severity during the past week on a scale from 0 to 100, with higher scores indicating greater cough severity.
Percentage of Scheduled Weekly Breathlessness Assessments Completed (Breathlessness Visual Analogue Scale)
时间窗: Up to 52 weeks
Calculated as the number of scheduled weekly Breathlessness Visual Analogue Scale assessments completed by participants divided by the total number of scheduled Breathlessness Visual Analogue Scale assessments, multiplied by 100. The Breathlessness Visual Analogue Scale assesses breathlessness severity during the past week on a scale from 0 to 100, with higher scores indicating greater breathlessness severity.
Percentage of Scheduled Patient-Reported Measures Completed
时间窗: Baseline, 3 months, 6 months, 9 months and 12 months
Completion of scheduled patient-reported measures will be assessed across the Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM), Idiopathic Pulmonary Fibrosis Patient Reported Experience Measure (IPF-PREM), EQ-5D-5L, SpiroQ Home Spirometry Satisfaction Questionnaire, Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), and Porter-Novelli 10-item Patient Engagement Scale. The outcome will be calculated as the number of scheduled patient-reported measures completed divided by the total number of patient-reported measures scheduled for completion, multiplied by 100, and reported as a percentage.
Percentage of Clinician-Confirmed Clinical Deterioration Events Without a Preceding AIRM Alert
时间窗: Up to 52 weeks
Calculated as the number of clinician-confirmed clinical deterioration events occurring without a preceding AIRM alert within the previous 4 weeks divided by the total number of clinician-confirmed clinical deterioration events, multiplied by 100. The outcome will be reported as a percentage.
Number of Device-Related Adverse Events
时间窗: Up to 52 weeks
Number of adverse events related to the remote monitoring devices or monitoring platform during the 12-month active remote monitoring period.
Percentage of Participants Reporting Remote Monitoring as Easy or Very Easy
时间窗: Baseline, 3 months, 6 months, 9 months and 12 months
Participant acceptability will be assessed using the SpiroQ Satisfaction Questionnaire. Participants rate the ease of remote monitoring using response categories ranging from "very easy" to "very difficult", with an additional "I don't know/not applicable" option. The outcome will be reported as the percentage of participants selecting "easy" or "very easy."
Clinician Perspectives on the Acceptability of AIRM
时间窗: Up to 15 months
Clinician acceptability will be explored through focus groups with clinicians involved in the AIRM remote monitoring pathway. Qualitative data will be analysed thematically to identify themes relating to the acceptability of using AIRM within clinical practice.
次要结局
- Percentage of AIRM Alerts That Are False-Positive Alerts(Up to 52 weeks)
- Sensitivity of AIRM for Identifying Clinically Significant Deterioration Events(Up to 52 weeks)
- Percentage of AIRM Alerts Leading to Clinical Review(Up to 52 weeks)
- Percentage of AIRM Alerts Leading to Clinical Intervention(Up to 52 weeks)
- Number of Emergency Hospital Admissions(Up to 12 months)
- Number of Outpatient Attendances(Up to 12 months)
- Number of Other Clinically Relevant Healthcare Contacts(Up to 12 months)