BPCO
Conditions
Brief summary
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.
Detailed description
The primary objective of the intervention is to optimize disease management and reduce the need for hospital-based healthcare resources. * Personalized Patient Monitoring: The telemonitoring system enables continuous, individualized follow-up, supporting proactive disease management and timely clinical decision-making. * Early Detection of Exacerbations: The HCAlert system continuously monitors physiological parameters, including heart rate, oxygen saturation (SpO₂), and blood pressure, and uses a triage algorithm to generate clinical alerts. This remote monitoring approach facilitates the early identification of clinical deterioration, allowing timely intervention before the patient's condition worsens, thereby potentially improving clinical outcomes. * Reduction in Healthcare Resource Utilization: Early clinical intervention is expected to reduce the rate of COPD-related hospitalizations, the number of COPD-related hospital days, and the frequency of COPD exacerbations. These improvements may translate into reduced healthcare resource utilization and lower healthcare costs. * Improved Quality of Life: By enabling patients to receive continuous monitoring and clinical support while remaining at home, telemonitoring may improve overall quality of life, increase patient reassurance, and promote better adherence to prescribed treatment plans.
Interventions
DEVICEPatients included in the intervention group will receive medical telemonitoring using the HCAlert medical device.
Patients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device.
Sponsors
Hope Care, S.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years or older. * Patient with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD), classified according to the GOLD ABE classification, who has experienced at least one COPD exacerbation within the previous 12 months. * Able and willing to provide written informed consent. * Able to comply with the telemonitoring procedures, including: * Performing physiological measurements on a regular basis; * Completing the required questionnaires. * Covered by a valid health insurance or social security scheme.
Exclusion criteria
* Receiving long-term oxygen therapy (LTOT) or non-invasive ventilation (NIV), regardless of the duration since prescription. * Presence of severe, unstable comorbidities that may interfere with the study outcomes, including but not limited to: * Decompensated heart failure; * Chronic kidney disease; * Asthma; * Other restrictive pulmonary diseases; * Psychotic mental disorders. * Participation in another interventional clinical study within the month preceding enrollment or during the study period. * Unavailable for follow-up or planning to relocate before completion of study participation. * Protected populations, including: * Pregnant or breastfeeding women, or women planning to become pregnant during the study period. For women of childbearing potential not using effective contraception, pregnancy will be ruled out by a urine or blood human chorionic gonadotropin (hCG) test before enrollment. * Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations. | 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: * Initiation of additional treatment, including short-acting bronchodilators, oral corticosteroids, and/or antibiotic therapy; * An emergency department visit or hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD. | 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. |
| To compare the medium-term impact of the HCAlert telemonitoring program on COPD exacerbation-related medical consultations in patients with COPD. | 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. |
| To evaluate the costs associated with COPD exacerbation-related hospitalizations, emergency department visits, and medical consultations through the HCAlert telemonitoring program. | 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. |
| To evaluate the impact of the telemonitoring program on the frequency of emergency department visits and medical consultations. | 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: * COPD-related hospitalization rate and COPD-related hospital days rate; * COPD exacerbation rate. |
| To describe the sociodemographic characteristics of the study population. | 12 months | Comparison of the demographic and clinical characteristics of patients receiving telemonitoring and those in the control group. |
| To evaluate adherence to the telemonitoring program. | 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). |
| To evaluate the impact of the HCAlert telemonitoring solution on the quality of life of patients in the intervention group. | 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. |
| To evaluate the COPD exacerbation rate at 6 months in patients with COPD. | 6 months | The COPD exacerbation rate over the 6-month follow-up period will be compared between the intervention and control groups. |
| To evaluate the proportion of patients without COPD exacerbation-related hospitalization or emergency department visits at 6 months. | 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. |
| To evaluate the environmental impact of the HCAlert telemonitoring program. | 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. |
Outcome results
None listed