Clinical Evaluation of COPD Butler in Patient Home Management (NCT03471091) | Clinical Trial Compass
UnknownNot Applicable
Clinical Evaluation of COPD Butler in Patient Home Management
China166 participantsStarted 2018-04-01
Plain-language summary
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.
Who can participate
Age range40 Years – 80 Years
SexALL
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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
What they're measuring
1
Adherence to NIV treatment
Timeframe: 12th month
Trial details
NCT IDNCT03471091
SponsorThe First Affiliated Hospital of Guangzhou Medical University