COPDNCT03471091
Clinical Evaluation of COPD Butler in Patient Home Management
A study testing NIV with the integrated tele-monitoring management program in people with COPD and Hypercapnic Respiratory Failure, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Hypercapnic Respiratory Failure
- What is being tested?
- NIV with the integrated tele-monitoring management program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong, 510120
Lili Guan, MD
About this study
Official title: Effect of the Integrated Network Management of Stable Hypercapnic COPD Patients With Domiciliary Noninvasive Ventilation Treatment
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.
Read the 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.
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Being tested
- NIV with the integrated tele-monitoring management program
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV with the integrated tele-monitoring management programDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: NIV with the integrated tele-monitoring management program |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Adherence to NIV treatment
The primary objective is to test the effect of COPD tele-monitoring program on patient's adherence to NIV treatment.
Measured: 12th month
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3rd, 6th and 12th month
COPD self-efficacy scale
Identifying situations in which individuals with COPD experience low self-efficacy is important.
Measured: Baseline, 6th and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Second Provincial General Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou First People's Hospital, Dongguan People's Hospital, Huizhou Municipal Central Hospital, Shenzhen People's Hospital, Clifford Hospital, Guangzhou, China, Shenzhen Sixth People's Hospital, Subei People's Hospital of Jiangsu Province
- Responsible party
- Principal investigator, Rongchang Chen, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, MD, Study director, Guangzhou Institute of Respiratory Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471091
- Sponsor's protocol ID
- GIRH-201801
- Status last verified
- Feb 2021
- First submitted
- 13 Mar 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Integrated Network Management of Stable Hypercapnic COPD Patients With Domiciliary Noninvasive Ventilation Treatment
- ClinicalTrials.gov ID
- NCT03471091
- Acronym / sponsor ID
- GIRH-201801
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Guangdong Second Provincial General Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou First People's Hospital, Dongguan People's Hospital, Huizhou Municipal Central Hospital, Shenzhen People's Hospital, Clifford Hospital, Guangzhou, China, Shenzhen Sixth People's Hospital, Subei People's Hospital of Jiangsu Province
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: NIV with the integrated tele-monitoring management programIntervention 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 | No intervention | –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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV with the integrated tele-monitoring management programNoninvasive 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. | Device | Intervention group |
Primary outcome
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.
9 secondary outcomes
Acute exacerbation of COPD re-admission rate
Time frame: Baseline, 1st, 3rd, 6th and 12th month
Severe Respiratory Insufficiency (SRI) Questionnaire
Time frame: Baseline, 3rd, 6th and 12th month
COPD assessment test
Time frame: Baseline, 1st, 3rd, 6th and 12th month
Partial pressure of arterial blood carbon dioxide (PaCO2)
Time frame: Baseline, 1st, 3rd, 6th and 12th month
6-minute walk test
Time frame: Baseline, 3rd, 6th and 12th month
Forced vital capacity
Time frame: Baseline, 3rd, 6th and 12th month
Forced expiratory volume in 1 second
Time frame: Baseline, 3rd, 6th and 12th month
Baseline Dyspnea Index/Transition Dyspnea Index
Time frame: Baseline, 3rd, 6th and 12th month
COPD self-efficacy scale
Time frame: Baseline, 6th and 12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongchang Chen, MD study director
Guangzhou Institute of Respiratory Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV with the integrated tele-monitoring management program in people with COPD and Hypercapnic Respiratory Failure, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luqian Zhou, PhD (+8615622236759, zhlx09@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to NIV treatment (time frame: 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.