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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Ruttens

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Wearable mobile device

    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.

  • CAT Questionnaire

    Other intervention

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

  • DHRQ Questionnaire

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients admitted with an acute COPD exacerbationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Vital parameter stabilization

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

Time frame
From enrollment to the end of treatment at 3 months
2

Compliance rate

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

Time frame
From enrollment to the end of treatment at 3 months

Secondary outcomes

1

Change in AECOPD symptoms

Change in AECOPD symptoms, as measured by the COPD Assessment Test questionnaire

Time frame
From enrollment to the end of treatment at 3 months
2

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.

Time frame
From enrollment to the end of treatment at 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Ruttens

Lead sponsor

Ziekenhuis Oost-Limburg

Sponsor institution