Clinical Evaluation of COPD Butler in Patient Home Management

Guangzhou Medical University

Status: Unknown

Conditions: Hypercapnic Respiratory Failure; COPD

Treatments: Device: NIV with the integrated tele-monitoring management program

Study type: Interventional

Funder types: Other

Identifiers

NCT03471091

GIRH-201801

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 40-80, males and females
2. Stage III and IV COPD
3. Daytime hypercapnia (PaCO2 ≥ 50 mmHg) at rest without ventilatory support
4. Possess home oxygen concentrator
5. Participants/Caregivers have access to and capable of using smartphone and internet
6. Willing to participate in the study
7. Able to provide informed consent

Exclusion criteria

1. Subjects with NIV as routine therapy prior to the study
2. Subjects with abnormalities of the lung or thorax other than COPD
3. Subjects with obstructive sleep apnea, COPD with obstructive sleep apnea overlap syndrome, severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities
4. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
5. Subjects who participated in another trial within 30 days prior to the planned start of study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Device: NIV with the integrated tele-monitoring management program

Control group

No Intervention group

Description:

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.