Effect of the Integrated Network Management of Stable Hypercapnic COPD Patients With Domiciliary Noninvasive Ventilation Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Adherence to NIV treatment
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a worldwide common disease with high morbidity and mortality and leads to heavy social and economic burden. Health management of stable COPD patients has been suggested to be essential for delaying diseases progress, reducing acute exacerbation events and improving patient quality of life. Non-invasive ventilation (NIV) is a widely used treatment in COPD patients. There were studies shown that NIV could improve ventilation, blood gases etc., and several clinical trials have shown improvements in survival, exercise capacity, quality of life and so on. Compliance to NIV and optimal parameter setting are important factors that will affect the effect of the use of NIV, thus NIV usage monitoring might also be a crucial element in the health management of COPD patients. Many studies have been designed to study the effect of tele-monitoring program on the management of COPD patients. However, almost none of these studies were designed for specific population, and little is known about the effect of such program on the management of patients with NIV treatment.
详细描述
The COPD home management program consists of 3 Philips devices (NIV BiPAP ST, Oximeter and Blood Pressure Meter), a patient mobile APP which is developed for self-management at home and a professional physician web portal which is designed for NIV usage and other vital sign data monitoring. The program is intended to manage the post-discharge COPD patient by enhancing COPD patient condition monitoring and adherence to the home therapy, e.g. NIV in this study. Besides obtaining clinical proof points of the efficacy of such program on patients with NIV treatment, it will provide potential evidence of the usability as well as the collect the insights for future product improvement.
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
- Single (Outcomes Assessor)
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
- •Age 40-80, males and females
- •Stage III and IV COPD
- •Daytime hypercapnia (PaCO2 ≥ 50 mmHg) at rest without ventilatory support
- •Possess home oxygen concentrator
- •Participants/Caregivers have access to and capable of using smartphone and internet
- •Willing to participate in the study
- •Able to provide informed consent
排除标准
- •Subjects with NIV as routine therapy prior to the study
- •Subjects with abnormalities of the lung or thorax other than COPD
- •Subjects with obstructive sleep apnea, COPD with obstructive sleep apnea overlap syndrome, severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities
- •Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
- •Subjects who participated in another trial within 30 days prior to the planned start of study
研究组 & 干预措施
Intervention group
Intervention group subjects will use NIV with the integrated tele-monitoring management program as home therapy and accomplish the following tasks via mobile COPD Butler APP: 1) upload daily NIV usage data， blood pressure, oxygen saturation, and heart rate measurement; 2) daily medication taken recording; 3) regular self-reported health questionnaire and symptom recording; 4) read health education materials.
Information collected from the intervention group by the APP will be monitored by physician team from the leading hospital through physician web portal. The physician team will provide regular health report, and once an alert is generated due to the abnormality in NIV usage or vital sign data etc., physicians will take action accordingly.
干预措施: NIV with the integrated tele-monitoring management program (Device)
Control group
Control group subjects will only use NIV according to their treatment plan at home. NIV usage data will be read from the NIV secure digital memory card for the control group.
结局指标
主要结局
Adherence to NIV treatment
时间窗: 12th month
The primary objective is to test the effect of COPD tele-monitoring program on patient's adherence to NIV treatment.
次要结局
- COPD assessment test(Baseline, 1st, 3rd, 6th and 12th month)
- Severe Respiratory Insufficiency (SRI) Questionnaire(Baseline, 3rd, 6th and 12th month)
- Forced expiratory volume in 1 second(Baseline, 3rd, 6th and 12th month)
- Acute exacerbation of COPD re-admission rate(Baseline, 1st, 3rd, 6th and 12th month)
- Partial pressure of arterial blood carbon dioxide (PaCO2)(Baseline, 1st, 3rd, 6th and 12th month)
- 6-minute walk test(Baseline, 3rd, 6th and 12th month)
- Forced vital capacity(Baseline, 3rd, 6th and 12th month)
- Baseline Dyspnea Index/Transition Dyspnea Index(Baseline, 3rd, 6th and 12th month)
- COPD self-efficacy scale(Baseline, 6th and 12th month)
研究者
Rongchang Chen
Professor
The First Affiliated Hospital of Guangzhou Medical University