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临床试验/NCT06890767
NCT06890767进行中(未招募)不适用

Remote Monitoring of COPD Patients Experiencing an Acute Exacerbation Through Health Evaluations Using Wearable Mobile Technology

David Ruttens2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
2
主要终点
Vital parameter stabilization

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) causes about 3 million deaths annually and significantly burdens healthcare systems, costing the EU 38.6 billion euros, largely due to frequent hospitalizations triggered by acute exacerbations (AECOPD). AECOPD worsens patient health, accelerates lung decline, and lowers quality of life, highlighting the need for early detection. Moreover, these AECOPD events happen in an out-hospital setting and are therefore, not preventable. A clear clinical and quality-of-life need arises to reduce AECOPD-related events and consequent hospitalizations.

Mobile health (mHealth) offers a solution by monitoring patients remotely using unobtrusive wearable devices. Parameters like peripheral oxygen saturation (SpO2) and respiratory rate can detect and predict exacerbations. However, no data at home is available of AECOPD events and robust predictive algorithms are lacking. This study aims to monitor vital parameters at home, tracking physical activity, pulse, respiratory rate, SpO2, sleep, and skin temperature from the moment of ER admission until three months post-discharge. Data will be used to gain insight in the COPD progression following an AECOPD event and to construct a predictive model, enabling timely intervention, reducing hospitalizations, and improving outcomes.

详细描述

Chronic obstructive pulmonary disease (COPD) is a common and life-threatening lung condition responsible for approximately three million deaths worldwide each year. The disease poses a substantial burden not only on individuals but also on healthcare systems. In the European Union, COPD accounts for 56% of annual healthcare costs related to respiratory diseases, equating to 38.6 billion euros.

A significant portion of these costs arises from the worsening of disease symptoms urging frequent (re)hospitalizations. These hospitalizations are typically triggered by flare-ups, also known as acute exacerbations of COPD (AECOPD). Such flare-ups often have a multifactorial origin e.g. bacterial or viral airway infection) and demand timely medical intervention to mitigate their impact.

AECOPD adversely affects the patient's health status, accelerates the decline in lung function, worsens prognosis, and significantly diminishes quality of life. Therefore, early detection of exacerbations is essential to prevent further disease progression and reduce hospital admissions.

Mobile health (mHealth) presents a promising solution for monitoring COPD patients at home remotely. Currently, the health of COPD patients outside of the hospital remains largely unmonitored-a "black box." By using wearable mobile technology to measure multiple parameters (e.g. oxygen saturation, respiratory rate, etc), it may become possible to predict disease worsening early and enable timely intervention. Previous studies have highlighted that monitoring peripheral oxygen saturation (SpO2) and respiratory rate can be useful in predicting AECOPD, but predicting algorithms are still lacking.

In this clinical study, following parameters will be monitored: physical activity, continuous heart rate, respiratory rate & breaths per minute, SpO2, sleep patterns, and core body temperature using a wearable mobile device. These parameters will be tracked from when patients are admitted to the emergency room (ER) until three months after hospital discharge or until rehospitalization due to AECOPD. The data collected will be used to gain insight in the COPD progression following an AECOPD event and construct a prediction model capable of forecasting disease deterioration. This model could enable timely medical intervention in the future, potentially preventing hospitalizations and improving patient outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Provide signed and dated informed consent
  • Adults older than 18 years of age
  • Previously diagnosed with COPD
  • Speak and understand the Dutch language
  • Need for hospitalization

排除标准

  • Previous diagnosis of asthma
  • Not in the possession of a smartphone

研究组 & 干预措施

Patients admitted with an acute COPD exacerbation

Experimental

Wearable mobile device

干预措施: Wearable mobile device (Device)

Patients admitted with an acute COPD exacerbation

Experimental

Wearable mobile device

干预措施: CAT Questionnaire (Other)

Patients admitted with an acute COPD exacerbation

Experimental

Wearable mobile device

干预措施: DHRQ Questionnaire (Other)

结局指标

主要结局

Vital parameter stabilization

时间窗: From enrollment to the end of treatment at 3 months

Number of days until stabilization of vital parameters measured with help of a remote monitoring system.

Compliance rate

时间窗: From enrollment to the end of treatment at 3 months

Compliance rate to the remote monitoring system (expressed in %)

次要结局

  • Change in AECOPD symptoms(From enrollment to the end of treatment at 3 months)
  • Correlation remote monitoring and subjective questionnaire(From enrollment to the end of treatment at 3 months)

研究者

发起方
David Ruttens
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Ruttens

Prof. Dr.

Ziekenhuis Oost-Limburg

研究点 (2)

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