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

NCT06890767 | Recruiting DMC

• 2 other identifiers: Z-2024106B3712024000024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Acute Exacerbation of COPD

Keywords

Mobile Health; COPD; Remote Monitoring; AECOPD

Outcome Measures

Primary Outcomes (2)

• Vital parameter stabilization

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

  From enrollment to the end of treatment at 3 months

• Compliance rate

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

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (2)

• 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

Study Arms (1)

Patients admitted with an acute COPD exacerbation

EXPERIMENTAL

Wearable mobile device

Device: Wearable mobile device; Other: CAT Questionnaire; Other: DHRQ Questionnaire

Interventions

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.

Patients admitted with an acute COPD exacerbation

CAT Questionnaire OTHER

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

Patients admitted with an acute COPD exacerbation

DHRQ Questionnaire OTHER

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

Patients admitted with an acute COPD exacerbation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• David Ruttens: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruben Knevels, MSc

CONTACT

+3289804029; ruben.knevels@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 24, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BE (1)