RecruitingNot ApplicableNCT06890767

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


Sponsor

David Ruttens

Enrollment

50 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria2

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

Interventions

DEVICEWearable mobile device

Patients admitted due to an acute COPD exacerbation will be asked to wear the wearable mobile device for a period of 3 months. An app linked to the device will be installed on their phone, and be used to send vital parameter data to the investigators.

OTHERCAT Questionnaire

During the time of hospital admission and at the end of study, a COPD Assessment Test questionnaire will be taken.

OTHERDHRQ Questionnaire

During the time of hospital admission, the patient will be asked to fill in the Digital Health Readiness Questionnaire


Locations(1)

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

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NCT06890767


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