Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD) (EProTele)
2026년 7월 6일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
340
단계
- 해당 없음
참여기준
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자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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간섭 없음: Control group
Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD.
기간: 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.
기간: 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.
기간: 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.
기간: 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
|
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To describe the sociodemographic characteristics of the study population.
기간: 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.
기간: 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.
기간: 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.
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6 and 12 months
|
|
To evaluate the COPD exacerbation rate at 6 months in patients with COPD.
기간: 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.
기간: 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.
기간: 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
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2028년 5월 31일
연구 완료 (추정된)
2028년 11월 30일
연구 등록 날짜
최초 제출
2026년 6월 30일
QC 기준을 충족하는 최초 제출
2026년 7월 6일
처음 게시됨 (실제)
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 6일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-A00562-49
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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