Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD) (EProTele)
6 de julio de 2026 actualizado por: Hope Care, S.A
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
340
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention group
Patients in this group receive medical telemonitoring using the HCAlert platform.
|
Patients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device.
|
|
Sin intervención: Control group
Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
Periodo de tiempo: 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:
|
COPD exacerbation over 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD.
Periodo de tiempo: 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.
|
12-month follow-up
|
|
To compare the medium-term impact of the HCAlert telemonitoring program on COPD exacerbation-related medical consultations in patients with COPD.
Periodo de tiempo: 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.
|
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.
Periodo de tiempo: 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.
|
12 months
|
|
To evaluate the impact of the telemonitoring program on the frequency of emergency department visits and medical consultations.
Periodo de tiempo: 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:
|
12 months
|
|
To describe the sociodemographic characteristics of the study population.
Periodo de tiempo: 12 months
|
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.
Periodo de tiempo: 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).
|
12 months
|
|
To evaluate the impact of the HCAlert telemonitoring solution on the quality of life of patients in the intervention group.
Periodo de tiempo: 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.
|
6 and 12 months
|
|
To evaluate the COPD exacerbation rate at 6 months in patients with COPD.
Periodo de tiempo: 6 months
|
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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
|
12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
31 de mayo de 2028
Finalización del estudio (Estimado)
30 de noviembre de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2026-A00562-49
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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