About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Provide signed and dated informed consent
Adults older than 18 years of age
Previously diagnosed with COPD
Speak and understand the Dutch language
Disqualifiers
Previous diagnosis of asthma
Not in the possession of a smartphone
Trial design
Single group
Treatments tested in this trial
Wearable mobile device
DevicePatients 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.
CAT Questionnaire
Other interventionDuring the time of hospital admission and at the end of study, a COPD Assessment Test questionnaire will be taken.
DHRQ Questionnaire
Other interventionDuring the time of hospital admission, the patient will be asked to fill in the Digital Health Readiness Questionnaire
Treatment groups
Trial outcomes
Primary outcomes
Vital parameter stabilization
Number of days until stabilization of vital parameters measured with help of a remote monitoring system.
Compliance rate
Compliance rate to the remote monitoring system (expressed in %)
Secondary outcomes
Change in AECOPD symptoms
Change in AECOPD symptoms, as measured by the COPD Assessment Test questionnaire
Correlation remote monitoring and subjective questionnaire
The correlation between objectively measured remote monitoring data and a subjective questionnaire. As the questionnaire is mainly focused on COPD symptoms, the correlation will be made with the peripheral oxygen saturation data.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
David Ruttens
Lead sponsor
Ziekenhuis Oost-Limburg
Sponsor institution