search
Back to results

Clinical Evaluation of COPD Butler in Patient Home Management

Primary Purpose

COPD, Hypercapnic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NIV with the integrated tele-monitoring management program
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence to NIV treatment
The primary objective is to test the effect of COPD tele-monitoring program on patient's adherence to NIV treatment.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
COPD self-efficacy scale
Identifying situations in which individuals with COPD experience low self-efficacy is important.

Full Information

First Posted
March 13, 2018
Last Updated
February 26, 2021
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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
search

1. Study Identification

Unique Protocol Identification Number
NCT03471091
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypercapnic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NIV with the integrated tele-monitoring management program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to NIV treatment
Description
The primary objective is to test the effect of COPD tele-monitoring program on patient's adherence to NIV treatment.
Time Frame
12th month
Secondary Outcome Measure Information:
Title
Acute exacerbation of COPD re-admission rate
Description
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
Title
Severe Respiratory Insufficiency (SRI) Questionnaire
Description
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
Title
COPD assessment test
Description
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
Title
Partial pressure of arterial blood carbon dioxide (PaCO2)
Description
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
Title
6-minute walk test
Description
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
Title
Forced vital capacity
Description
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
Title
Forced expiratory volume in 1 second
Description
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
Title
Baseline Dyspnea Index/Transition Dyspnea Index
Description
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
Title
COPD self-efficacy scale
Description
Identifying situations in which individuals with COPD experience low self-efficacy is important.
Time Frame
Baseline, 6th and 12th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luqian Zhou, PhD
Phone
+8615622236759
Email
zhlx09@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen, MD
Organizational Affiliation
Guangzhou Institute of Respiratory Health
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Guan, MD

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of COPD Butler in Patient Home Management

We'll reach out to this number within 24 hrs