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[慢性阻塞性肺疾病患者的远程医疗监测(远程指导慢性阻塞性肺疾病):一项多中心、随机、对照研究的研究方案]

[TELEMEdical moNiTORing for COPD patients (Telementor COPD): Study protocol of a multicentre, randomised, controlled study].

作者信息

Püschner Franziska, Schiller Juliane, Urbanski-Rini Dominika, Scholl Katharina, Bock Anni, Jandl Margret, Thanhäuser Andreas, Zils Lale, Junker Erwin, Rabe Klaus, Watz Henrik

机构信息

Privates Institut für angewandte Versorgungsforschung GmbH (inav), Berlin, Deutschland.

LungenClinic Großhansdorf, Großhansdorf, Deutschland.

出版信息

Pneumologie. 2025 May;79(5):358-365. doi: 10.1055/a-2383-4470. Epub 2024 Aug 29.

Abstract

COPD is one of the most common causes of death in Europe, and is associated with a high exacerbation and hospitalization rate as well as high medical costs. The aim of the study was early detection of exacerbations, preventative intervention through optimized outpatient care, and thereby to decrease rates of rehospitalizations. Telementor COPD is a prospective, multicentre, unblinded, randomized, controlled study with a study duration of 12 months, implemented at seven clinics and 16 pneumology practices in Hamburg and Schleswig-Holstein. It is funded by the Innovation Fund (01NVF20008) and is registered in the German Register of Clinical Studies (study ID: DRKS00027961). COPD patients with at least one documented exacerbation in the last year were included in the study. The primary endpoint was the number of exacerbations. Secondary endpoints were the number of COPD-associated hospitalizations, intensive care unit stays and health status. In the intervention group, symptoms were recorded daily using the SaniQ app (patients' smartphones), and the FEV was measured daily using a mobile spirometer. Patients were also provided with a smartwatch to continuously measure their respiratory rate, heart rate, oxygen saturation and steps. The app displays the measured values and offers motivational components for smoking cessation and physical activity as well as video chats with the COPD nurses and doctors. If the symptoms or lung function deteriorated, the trained COPD nurse contacted the patient, reviewed the patient's measurements, and assessed the need for preventive intervention. Telementor COPD offers the opportunity to evaluate the efficacy of digital monitoring and telemedicine components and to pave the way for the implementation of telemedicine in the routine care of COPD patients with a high risk of exacerbation.

摘要

慢性阻塞性肺疾病(COPD)是欧洲最常见的死亡原因之一,与高急性加重率、高住院率以及高昂的医疗费用相关。本研究的目的是早期发现急性加重情况,通过优化门诊护理进行预防性干预,从而降低再次住院率。“远程指导COPD”研究是一项前瞻性、多中心、非盲、随机对照研究,研究时长为12个月,在汉堡和石勒苏益格-荷尔斯泰因州的7家诊所和16家肺病诊疗机构开展。该研究由创新基金(01NVF20008)资助,并已在德国临床研究注册库注册(研究编号:DRKS00027961)。过去一年中至少有一次记录在案的急性加重情况的COPD患者被纳入本研究。主要终点是急性加重的次数。次要终点包括与COPD相关的住院次数、重症监护病房停留时间和健康状况。在干预组中,使用SaniQ应用程序(患者的智能手机)每日记录症状,并使用便携式肺功能仪每日测量第一秒用力呼气容积(FEV)。还为患者提供了智能手表,以持续测量他们的呼吸频率、心率、血氧饱和度和步数。该应用程序显示测量值,并提供戒烟和体育活动的激励内容,以及与COPD护士和医生的视频聊天功能。如果症状或肺功能恶化,经过培训的COPD护士会联系患者,查看患者的测量数据,并评估预防性干预的必要性。“远程指导COPD”研究提供了评估数字监测和远程医疗组件疗效的机会,并为在急性加重风险高的COPD患者的常规护理中实施远程医疗铺平道路。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5cc4/12068928/7e3e129f9d7e/10-1055-a-2383-4470_23834705.jpg

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