A Randomized Controlled Trial of Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 236
- 试验地点
- 4
- 主要终点
- Change in Health-Related Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Remote Intervention Group
Participants will receive home non-invasive respiratory support combined with active remote management.
干预措施: Remote Management (Other)
Remote Intervention Group
Participants will receive home non-invasive respiratory support combined with active remote management.
干预措施: Remote Monitoring Only (Other)
Monitoring Control Group
Participants will receive home non-invasive respiratory support with remote monitoring only.
干预措施: Remote Monitoring Only (Other)
结局指标
主要结局
Change in Health-Related Quality of Life
时间窗: Baseline to 12 months
Measured by the change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) questionnaire at 12 months.
Number of COPD Exacerbations
时间窗: 12 months
The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months.
次要结局
- Changes in PaO₂(Baseline, 1, 3, 6, 12 months)
- Change in PaCO₂(Baseline, 1, 3, 6, 12 months)
- Change in Dyspnea Severity (mMRC Score)(Baseline, 1, 3, 6, 12 months)
- Change in CAT Score(Baseline, 1, 3, 6, and 12 months)
- Change in SRI Score(Time Frame: Baseline, 1, 3, 6, and 12 months)
- Average daily usage of Non-invasive Ventilation(Baseline, 1, 3, 6, and 12 months)
- Adherence-Percentage of days with usage greater than 4 hours(Baseline, 1, 3, 6, and 12 months)
- Adverse Events(Baseline, 1, 3, 6, and 12 months)
研究者
Huiqing Ge
Director, Respiratory Care Department
Sir Run Run Shaw Hospital