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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.
The primary objective of the intervention is to optimize disease management and reduce the need for hospital-based healthcare resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patients in this group receive medical telemonitoring using the HCAlert platform. |
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| Control group | No Intervention | Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device. | Device | Patients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations. | 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:
| COPD exacerbation over 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD. | 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. | 12-month follow-up |
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Inclusion Criteria:
Exclusion Criteria
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This is a national, multicenter, prospective, longitudinal, randomized controlled interventional study with two parallel treatment arms (1:1 allocation), stratified by study center and GOLD ABE classification (Groups A/B vs. Group E).
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| To compare the medium-term impact of the HCAlert telemonitoring program on COPD exacerbation-related medical consultations in patients with COPD. | 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. | 12-month follow-up |
| To evaluate the costs associated with COPD exacerbation-related hospitalizations, emergency department visits, and medical consultations through the HCAlert telemonitoring program. | 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. | 12 months |
| To evaluate the impact of the telemonitoring program on the frequency of emergency department visits and medical consultations. | 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:
| 12 months |
| To describe the sociodemographic characteristics of the study population. | Comparison of the demographic and clinical characteristics of patients receiving telemonitoring and those in the control group. | 12 months |
| To evaluate adherence to the telemonitoring program. | 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). | 12 months |
| To evaluate the impact of the HCAlert telemonitoring solution on the quality of life of patients in the intervention group. | 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. | 6 and 12 months |
| To evaluate the COPD exacerbation rate at 6 months in patients with COPD. | The COPD exacerbation rate over the 6-month follow-up period will be compared between the intervention and control groups. | 6 months |
| To evaluate the proportion of patients without COPD exacerbation-related hospitalization or emergency department visits at 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. | 6 months |
| To evaluate the environmental impact of the HCAlert telemonitoring program. | 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. | 12 months |