Naqvi Marium, Borton Rebecca, Lines Sarah, Dallas Joanne, Mandizha Jessica, Almond Howard, Edwards Colin, Adams Wendy, Gibbons Michael, Russell Anne-Marie, West Alex
Department of Respiratory Medicine, Guy's and St Thomas Hospitals NHS Trust, London, United Kingdom.
Peter Gorer Department of Immunobiology, King's College London, London, United Kingdom.
JMIR Res Protoc. 2025 Jun 12;14:e65339. doi: 10.2196/65339.
Interstitial lung diseases (ILDs), a group of parenchymal lung disorders, present with varying degrees of inflammation and fibrosis, which lead to symptoms such as progressive breathlessness, impaired quality of life (QoL), and reduced life expectancy. Patients with ILD can experience a sudden worsening of their condition, known as an acute exacerbation, which is associated with inappropriate hospital admissions, concomitant National Health Service (NHS) costs, impaired QoL, and high mortality. The heterogeneity of ILDs, the unpredictability of acute exacerbations, and significant variation in disease progression and response to treatment present numerous management challenges. Standard care typically involves 3-6 monthly hospital outpatient visits to monitor disease and assess response to treatment. Home monitoring with remote review of spirometry, pulse oximetry, and patient-reported measures offers an alternative approach to in-person clinic review and laboratory-based physiological measurements. Clinical trials indicate home monitoring of patients with ILD is acceptable, and results correlate with laboratory-based pulmonary function tests (PFTs). The impact of implementing home monitoring for patients with ILD in a real-world setting is not well understood.
We aim to evaluate the safety, effectiveness, and acceptability of home monitoring with standard care in the management of patients with ILD.
This study has been registered as a quality improvement project at Guy's and St Thomas' NHS Foundation Trust (reference 13660) and Royal Devon University Healthcare NHS Foundation Trust (reference 24-1378). The project has been co-designed by the steering group, including clinicians, researchers, technology partners, a patient advocacy charity, and patients diagnosed with ILD. Patients who meet the inclusion criteria will be provided a handheld spirometer, pulse oximeter, and access to patientMpower, an electronic health app, on their smart devices and followed up for 12 months. All participants will be asked to complete at least once weekly home spirometry and pulse oximetry measurements and 3 monthly patient-reported measures, including outcome, engagement, and experience measures, using the patientMpower app. Results will be available to the clinicians in real time and used to monitor disease progression, symptoms, and QoL, and to assess treatment response.
This study was funded by NHS Digital in September 2021. Patient recruitment and data collection started in March 2022. By January 2024, 186 patients were enrolled. All patients will have home monitoring for at least 12 months. Results are expected to be published at the end of 2025.
We hypothesize home monitoring will be safe, effective and acceptable for patients with ILD and result in a 50% reduction in routine laboratory-based pulmonary function tests and in-person clinic consultations.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65339.
间质性肺疾病（ILDs）是一组实质性肺部疾病，表现出不同程度的炎症和纤维化，导致进行性呼吸困难、生活质量（QoL）受损和预期寿命缩短等症状。ILD患者可能会出现病情突然恶化，即急性加重，这与不适当的住院、国民医疗服务体系（NHS）的相关费用、QoL受损和高死亡率有关。ILD的异质性、急性加重的不可预测性以及疾病进展和对治疗反应的显著差异带来了众多管理挑战。标准护理通常包括每3至6个月进行一次医院门诊就诊，以监测疾病并评估治疗反应。通过远程审查肺活量测定、脉搏血氧饱和度测定和患者报告的指标进行家庭监测，为亲自到诊所复查和基于实验室的生理测量提供了一种替代方法。临床试验表明，对ILD患者进行家庭监测是可以接受的，且结果与基于实验室的肺功能测试（PFTs）相关。在现实环境中对ILD患者实施家庭监测的影响尚不清楚。
我们旨在评估在ILD患者管理中，家庭监测联合标准护理的安全性、有效性和可接受性。
本研究已在盖伊和圣托马斯国民医疗服务基金会信托（参考编号13660）以及皇家德文郡大学医疗国民医疗服务基金会信托（参考编号24 - 1378）注册为质量改进项目。该项目由指导小组共同设计，指导小组包括临床医生、研究人员、技术合作伙伴、患者权益倡导慈善机构以及被诊断为ILD的患者。符合纳入标准的患者将在其智能设备上获得一台手持式肺活量计、脉搏血氧仪，并可使用电子健康应用程序patientMpower，并进行为期12个月的随访。所有参与者将被要求至少每周完成一次家庭肺活量测定和脉搏血氧饱和度测定，并每3个月使用patientMpower应用程序完成患者报告的指标，包括结果、参与度和体验指标。结果将实时提供给临床医生，用于监测疾病进展、症状和QoL，并评估治疗反应。
本研究于2021年9月由NHS Digital资助。患者招募和数据收集于2022年3月开始。截至2024年1月，已招募186名患者。所有患者将进行至少12个月的家庭监测。预计结果将于2025年底公布。
我们假设家庭监测对ILD患者将是安全、有效且可接受的，并能使基于实验室的常规肺功能测试和亲自到诊所就诊的次数减少50%。
国际注册报告识别码（IRRID）：DERR1-10.2196/65339。
