- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471091
Clinical Evaluation of COPD Butler in Patient Home Management
Effect of the Integrated Network Management of Stable Hypercapnic COPD Patients With Domiciliary Noninvasive Ventilation Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luqian Zhou, PhD
- Phone Number: +8615622236759
- Email: zhlx09@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Recruiting
- The First Affiliated Hospital of Guangzhou Medical University.
-
Contact:
- Lili Guan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention 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. |
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.
|
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to NIV treatment
Time Frame: 12th month
|
The primary objective is to test the effect of COPD tele-monitoring program on patient's adherence to NIV treatment.
|
12th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute exacerbation of COPD re-admission rate
Time Frame: Baseline, 1st, 3rd, 6th and 12th month
|
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.
|
Baseline, 1st, 3rd, 6th and 12th month
|
Severe Respiratory Insufficiency (SRI) Questionnaire
Time Frame: Baseline, 3rd, 6th and 12th month
|
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.
|
Baseline, 3rd, 6th and 12th month
|
COPD assessment test
Time Frame: Baseline, 1st, 3rd, 6th and 12th month
|
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.
|
Baseline, 1st, 3rd, 6th and 12th month
|
Partial pressure of arterial blood carbon dioxide (PaCO2)
Time Frame: Baseline, 1st, 3rd, 6th and 12th month
|
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.
|
Baseline, 1st, 3rd, 6th and 12th month
|
6-minute walk test
Time Frame: Baseline, 3rd, 6th and 12th month
|
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.
|
Baseline, 3rd, 6th and 12th month
|
Forced vital capacity
Time Frame: Baseline, 3rd, 6th and 12th month
|
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.
|
Baseline, 3rd, 6th and 12th month
|
Forced expiratory volume in 1 second
Time Frame: Baseline, 3rd, 6th and 12th month
|
Forced expiratory volume in 1 second is a marker used to measure lung function and can help you monitor your lung diseases over time.
|
Baseline, 3rd, 6th and 12th month
|
Baseline Dyspnea Index/Transition Dyspnea Index
Time Frame: Baseline, 3rd, 6th and 12th month
|
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.
|
Baseline, 3rd, 6th and 12th month
|
COPD self-efficacy scale
Time Frame: Baseline, 6th and 12th month
|
Identifying situations in which individuals with COPD experience low self-efficacy is important.
|
Baseline, 6th and 12th month
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Rongchang Chen, MD, Guangzhou Institute of Respiratory Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIRH-201801
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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