Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD) (EProTele)
2026年7月6日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
340
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention group
Patients in this group receive medical telemonitoring using the HCAlert platform.
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Patients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device.
|
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介入なし：Control group
Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
時間枠：COPD exacerbation over 12 months
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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:
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COPD exacerbation over 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD.
時間枠：12-month follow-up
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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.
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12-month follow-up
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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.
時間枠：12-month follow-up
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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.
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12-month follow-up
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To evaluate the costs associated with COPD exacerbation-related hospitalizations, emergency department visits, and medical consultations through the HCAlert telemonitoring program.
時間枠：12 months
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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.
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12 months
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To evaluate the impact of the telemonitoring program on the frequency of emergency department visits and medical consultations.
時間枠：12 months
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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:
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12 months
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To describe the sociodemographic characteristics of the study population.
時間枠：12 months
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Comparison of the demographic and clinical characteristics of patients receiving telemonitoring and those in the control group.
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12 months
|
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To evaluate adherence to the telemonitoring program.
時間枠：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).
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12 months
|
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To evaluate the impact of the HCAlert telemonitoring solution on the quality of life of patients in the intervention group.
時間枠：6 and 12 months
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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.
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6 and 12 months
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To evaluate the COPD exacerbation rate at 6 months in patients with COPD.
時間枠：6 months
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The COPD exacerbation rate over the 6-month follow-up period will be compared between the intervention and control groups.
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6 months
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To evaluate the proportion of patients without COPD exacerbation-related hospitalization or emergency department visits at 6 months.
時間枠：6 months
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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.
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6 months
|
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To evaluate the environmental impact of the HCAlert telemonitoring program.
時間枠：12 months
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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
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年5月31日
研究の完了 (推定)
2028年11月30日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年7月6日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13日
QC基準を満たした最後の更新が送信されました
2026年7月6日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-A00562-49
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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