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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
166
Noninvasive positive pressure ventilation with the integrated tele-monitoring management 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.
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong, China
RECRUITINGAdherence to NIV treatment
The primary objective is to test the effect of COPD tele-monitoring program on patient's adherence to NIV treatment.
Time frame: 12th month
Acute exacerbation of COPD re-admission rate
Acute exacerbation which was characterized as an acute worsening of more than one respiratory symptom (new onset of or increase in sputum volume or purulence, wheezing, cough, dyspnoea, or fever) lasting for at least 2 consecutive days and result in any changes in their conventional therapy.
Time frame: Baseline, 1st, 3rd, 6th and 12th month
Severe Respiratory Insufficiency (SRI) Questionnaire
The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NIV. It includes 49 items on seven subscales.
Time frame: Baseline, 3rd, 6th and 12th month
COPD assessment test
The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.
Time frame: Baseline, 1st, 3rd, 6th and 12th month
Partial pressure of arterial blood carbon dioxide (PaCO2)
Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NIV for at least 1 hour.
Time frame: Baseline, 1st, 3rd, 6th and 12th month
6-minute walk test
The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases.
Time frame: Baseline, 3rd, 6th and 12th month
Forced vital capacity
Forced vital capacity is measured in a test known as spirometry, a type of pulmonary function test, which is used to help determine both the presence and severity of lung diseases.
Time frame: Baseline, 3rd, 6th and 12th month
Forced expiratory volume in 1 second
Forced expiratory volume in 1 second is a marker used to measure lung function and can help you monitor your lung diseases over time.
Time frame: Baseline, 3rd, 6th and 12th month
Baseline Dyspnea Index/Transition Dyspnea Index
Baseline Dyspnea Index/Transition Dyspnea Index provides a multidimensional measurement of dyspnea based on 3 components that evoke dyspnea in activities of daily living, in symptomatic individuals.
Time frame: Baseline, 3rd, 6th and 12th month
COPD self-efficacy scale
Identifying situations in which individuals with COPD experience low self-efficacy is important.
Time frame: Baseline, 6th and 12th month
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