Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
- 主要终点
- To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
研究组 & 干预措施
Intervention group
Patients in this group receive medical telemonitoring using the HCAlert platform.
干预措施: Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device. (Device)
Control group
Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care.
结局指标
主要结局
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
时间窗: 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.
次要结局
- 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)
- 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)
- To evaluate the costs associated with COPD exacerbation-related hospitalizations, emergency department visits, and medical consultations through the HCAlert telemonitoring program.(12 months)
- To evaluate the impact of the telemonitoring program on the frequency of emergency department visits and medical consultations.(12 months)
- To describe the sociodemographic characteristics of the study population.(12 months)
- To evaluate adherence to the telemonitoring program.(12 months)
- To evaluate the impact of the HCAlert telemonitoring solution on the quality of life of patients in the intervention group.(6 and 12 months)
- To evaluate the COPD exacerbation rate at 6 months in patients with COPD.(6 months)
- To evaluate the proportion of patients without COPD exacerbation-related hospitalization or emergency department visits at 6 months.(6 months)
- To evaluate the environmental impact of the HCAlert telemonitoring program.(12 months)