Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device.
DevicePatients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device.
NCT Number: NCT07697105
Telemonitoring systems have already demonstrated their ability to improve clinical follow-up and reduce healthcare resource utilization in patients with chronic respiratory failure treated with non-invasive ventilation (NIV) and/or long-term oxygen therapy (LTOT). In this severely ill population, telemonitoring enables earlier detection of clinical deteriorations, optimization of therapeutic interventions, and a reduction in unplanned hospitalizations.
Building on these findings, we hypothesize that similar benefits could be achieved in patients with chronic obstructive pulmonary disease (COPD) who are at risk of exacerbations, regardless of their clinical severity (GOLD ABE classification). The implementation of a structured telemonitoring program in this population could therefore help reduce the severity of exacerbations and, ultimately, decrease overall healthcare resource utilization.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
The primary objective of the intervention is to optimize disease management and reduce the need for hospital-based healthcare resources.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device.
Time frame: COPD exacerbation over 12 months
The proportion of patients without COPD-related hospitalization or emergency department visits due to a COPD exacerbation over the 12-month follow-up period will be compared between the intervention and control groups. A COPD exacerbation will be defined according to the GOLD recommendations as an acute worsening of respiratory symptoms requiring one or more of the following:
Time frame: 12-month follow-up
The change in the number of COPD exacerbation-related hospitalizations between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Time frame: 12-month follow-up
The change in the number of medical consultations related to COPD exacerbations between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Time frame: 12 months
The difference in costs associated with disease management, based on healthcare resource utilization, between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Time frame: 12 months
The change between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups for the following outcomes:
Time frame: 12 months
Comparison of the demographic and clinical characteristics of patients receiving telemonitoring and those in the control group.
Time frame: 12 months
Adherence to the telemonitoring program will be assessed based on the number of data entries completed by the patient throughout the follow-up period and for each month of participation (intervention group only).
Time frame: 6 and 12 months
The change in quality of life, as measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, between baseline (Month 0), Month 6, and Month 12, will be compared between the intervention and control groups.
Time frame: 6 months
The COPD exacerbation rate over the 6-month follow-up period will be compared between the intervention and control groups.
Time frame: 6 months
The proportion of patients without COPD exacerbation-related hospitalization or emergency department visits during the 6-month follow-up period will be compared between the intervention and control groups.
Time frame: 12 months
The change in carbon emissions associated with travel for medical consultations between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Hope Care, S.A
Industry
Acronym: EProTele
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.