NCT03471091

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

4.8 years

First QC Date

March 13, 2018

Last Update Submit

February 26, 2021

Conditions

COPDHypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Adherence to NIV treatment

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

    12th month

Secondary Outcomes (9)

  • Acute exacerbation of COPD re-admission rate

    Baseline, 1st, 3rd, 6th and 12th month

  • Severe Respiratory Insufficiency (SRI) Questionnaire

    Baseline, 3rd, 6th and 12th month

  • COPD assessment test

    Baseline, 1st, 3rd, 6th and 12th month

  • Partial pressure of arterial blood carbon dioxide (PaCO2)

    Baseline, 1st, 3rd, 6th and 12th month

  • 6-minute walk test

    Baseline, 3rd, 6th and 12th month

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University.

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Rongchang Chen, MD

    Guangzhou Institute of Respiratory Health

    STUDY DIRECTOR

Central Study Contacts

Luqian Zhou, PhD

CONTACT

+8615622236759zhlx09@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 20, 2018

Study Start

April 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 2, 2021

Record last verified: 2021-02

Locations

CN(1)