Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support

Официальное название

A Randomized Controlled Trial of Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support

Обзор

This study is a randomized controlled trial designed to compare the effectiveness of active remote intervention versus passive monitoring alone in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic hypercapnic respiratory failure who are receiving home non-invasive respiratory support. The primary goal is to evaluate the impact on health-related quality of life and the frequency of acute exacerbations over a 12-month period.

Подробное описание

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide. A subset of patients with severe COPD develops chronic hypercapnic respiratory failure, often requiring long-term home non-invasive ventilation (NIV). While NIV can improve gas exchange, optimal management strategies, particularly post-hospitalization, are still being investigated.

This study aims to determine if a proactive, remote management strategy can improve patient outcomes compared to standard care with passive monitoring.

Experimental Group (Remote Intervention): Participants will receive home NIV with remote monitoring. A respiratory therapist will actively review ventilation data, assess oxygenation, and perform remote parameter adjustments and individualized optimization based on pre-set conditions and risk predictions.

Control Group (Monitoring Control): Participants will receive home NIV with remote monitoring. However, the study team will not perform active interventions based on the monitoring data. Patients will continue with their usual care and follow-up with their primary physician. The study team will only make contact in case of a severe safety risk.

The study will enroll 236 participants who will be randomized 1:1 to one of the two groups. The primary outcomes are the change in health-related quality of life and the number of COPD exacerbations over 12 months.

Вмешательства

• Другое Remote Management
  Participants will receive home non-invasive respiratory support combined with active remote management. This includes regular analysis of ventilation data, assessment of oxygenation status, risk prediction, and remote parameter adjustment by a respiratory therapist.
• Другое Remote Monitoring Only
  Participants will receive home non-invasive respiratory support with remote monitoring only. No active intervention will be performed by the study team based on the data. Patients will continue with standard care from their primary physician.

Первичные конечные точки

• Change in Health-Related Quality of Life [Срок оценки: Baseline to 12 months]
• Number of COPD Exacerbations [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Change in PaCO₂ [Срок оценки: Baseline, 1, 3, 6, 12 months]
• Changes in PaO₂ [Срок оценки: Baseline, 1, 3, 6, 12 months]
• Change in Dyspnea Severity (mMRC Score) [Срок оценки: Baseline, 1, 3, 6, 12 months]
• Change in CAT Score [Срок оценки: Baseline, 1, 3, 6, and 12 months]
• Change in SRI Score [Срок оценки: Time Frame: Baseline, 1, 3, 6, and 12 months]
• Average daily usage of Non-invasive Ventilation [Срок оценки: Baseline, 1, 3, 6, and 12 months]
• Adherence-Percentage of days with usage greater than 4 hours [Срок оценки: Baseline, 1, 3, 6, and 12 months]
• Adverse Events [Срок оценки: Baseline, 1, 3, 6, and 12 months]

Критерии участия

Критерии включения

• Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) with confirmed persistent airflow limitation by spirometry.
• Hospitalized due to an acute exacerbation of COPD.
• Stable daytime arterial blood gas analysis showing PaCO₂ ≥ 50 mmHg, with hypoxemia.
• Already receiving or planned to receive long-term home non-invasive respiratory support.
• Capable of using a smartphone or tablet for video communication and has internet access.
• Willing to participate and provides written informed consent.

Критерии исключения

• Concurrent severe pulmonary diseases (e.g., active tuberculosis, diffuse pulmonary fibrosis, advanced lung cancer).
• Chronic respiratory failure primarily caused by non-COPD conditions (e.g., neuromuscular disease, chest wall deformity, or severe obesity hypoventilation syndrome).
• Severe cognitive impairment or psychiatric illness that would prevent cooperation with remote management.
• Other severe systemic diseases with an expected survival of less than 1 year (e.g., advanced malignancy).
• Pregnant or lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Henan Provincial People's Hospital — Чжэнчжоу
• The Second Xiangya Hospital of Central South University — Чанша
• Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University — Ханчжоу
• Taizhou Hospital of Integrated Traditional Chinese and Western Medicine — Wenling

Идентификаторы

NCT: NCT07751003 · 20260597

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗