Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD) (EProTele)
6 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
340
Фаза
- Непригодный
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Без вмешательства: Control group
Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
31 мая 2028 г.
Завершение исследования (Оцененный)
30 ноября 2028 г.
Даты регистрации исследования
Первый отправленный
30 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
6 июля 2026 г.
Первый опубликованный (Действительный)
13 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
13 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 2026-A00562-49
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .