Clinical trial NCT03471091: Clinical Evaluation of COPD Butler in Patient Home Management
Official title: Effect of the Integrated Network Management of Stable Hypercapnic COPD Patients With Domiciliary Noninvasive Ventilation Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Hypercapnic Respiratory Failure
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Guangdong Second Provincial General Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Guangzhou First People's Hospital
name: Dongguan People's Hospital
name: Huizhou Municipal Central Hospital
name: Shenzhen People's Hospital
name: Clifford Hospital, Guangzhou, China
name: Shenzhen Sixth People's Hospital
name: Subei People's Hospital of Jiangsu Province
First posted: 2018-03-20
Enrollment: 166
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to NIV treatment
timeFrame: 12th month
Secondary outcomes:
measure: Acute exacerbation of COPD re-admission rate
timeFrame: Baseline, 1st, 3rd, 6th and 12th month
measure: Severe Respiratory Insufficiency (SRI) Questionnaire
timeFrame: Baseline, 3rd, 6th and 12th month
measure: COPD assessment test
timeFrame: Baseline, 1st, 3rd, 6th and 12th month
measure: Partial pressure of arterial blood carbon dioxide (PaCO2)
timeFrame: Baseline, 1st, 3rd, 6th and 12th month
measure: 6-minute walk test
timeFrame: Baseline, 3rd, 6th and 12th month
measure: Forced vital capacity
timeFrame: Baseline, 3rd, 6th and 12th month
measure: Forced expiratory volume in 1 second
timeFrame: Baseline, 3rd, 6th and 12th month
measure: Baseline Dyspnea Index/Transition Dyspnea Index
timeFrame: Baseline, 3rd, 6th and 12th month
measure: COPD self-efficacy scale
timeFrame: Baseline, 6th and 12th month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University.
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Health
name: Rongchang Chen, MD
role: STUDY_DIRECTOR
References: