Clinical Evaluation of COPD Butler in Patient Home Management
COPD, Hypercapnic Respiratory Failure
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical University.Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention group
Control 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.
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.