COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
Pulmonary Rehabilitation, COPD, GOLD2024, Global Initiative for Chronic Obstructive Lung Disease, Digital Inhaled Therapy Management, Inspiratory Muscle Training
Brief summary
The goal of this clinical trial is to learn if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or in combination, can improve outcomes in adults aged 40 years and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) with moderate to severe airflow limitation (FEV1/FVC \< 60%). The main questions it aims to answer are: Does DITM reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does the combination of DITM and IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? What are the effects of DITM, IMT, and their combination on the time to first moderate to severe exacerbation, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) score, and St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (SGRQ-C) score? Researchers will compare four groups: a DITM group, an IMT group, a DITM+IMT group, and a control group receiving usual care, to see if these interventions improve outcomes related to COPD exacerbations, symptoms, quality of life, and inspiratory muscle strength. Participants will: DITM Group: Receive training on inhaler technique using a digital device and use a digital sensor with a mobile app for home-based inhalation management, including reminders and feedback. IMT Group: Receive verbal inhaler technique training and use a breathing trainer with accompanying software for inspiratory muscle training. DITM+IMT Group: Receive both the digital inhalation management and inspiratory muscle training interventions. Control Group: Receive verbal inhaler technique training only. All participants will undergo baseline assessments and follow-up assessments at 3, 6, and 12 months, including questionnaires, lung function tests, respiratory muscle strength measurements, and a 6-minute walk test. They will also report on any COPD exacerbations experienced during the study period.
Interventions
DEVICEDigital Inhaled Therapy Management
The subjects will be trained on their inhalation techniques with the "Digital Medication Administration Device" consists of an inhalation device with a display and inhalation technique assessment module. The device will show a standardized video demonstration and will evaluate the subjects' inhalation technique. A printed report will be available afterwards. A home-based inhalation management service package will be provided to the subjects including a digital sensor that records the time, frequency, and key inhalation technique parameters for each use of metered-dose inhalers or dry powder inhalers, and automatically synchronizes the data to the cloud. The data is then analyzed for adherence and technique performance. Based on the data, subjects will receive medication reminders and voice alerts for any technique errors on the app provided with the package. Visual charts of medication adherence and inhalation technique will be available to reinforce self-management.
DEVICEInspiratory Muscle Training
The subjects will receive standardized verbal training and demonstration of inhalation techniques and any questions will be answered Inspiratory muscle training equipment, ancillary software, inspiratory muscle training plan, and equipment user guide will be sent home with the patient.
Sponsors
Sir Run Run Shaw Hospital
Jingyao (Hangzhou) Health Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed as COPD according to "GOLD2024" * Lung function results FEV1/FVC\<60% * Patients with stable COPD who meet one of the following criteria: (A)with CAT score ≥10 or mMRC≥2; (B) ≥2 moderate acute exacerbation or ≥1 hospitalization in the past 12 months * Uses Budesonide MDI (Breztri Aerosphere) or Fluticasone, umeclidinium, and vilanterol (Trelegy Ellipta) or umeclidinium and vilanterol (Anoro Ellipta) as maintenance drug for COPD management * Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity, his/her guardian shall act on his/her behalf to read and sign the informed consent form.
Exclusion criteria
* Unstable angina or severe arrhythmia * Severe weakness-related fatigue, such as in advanced congestive heart failure or chemotherapy-related fatigue * Unstable mental illness with a risk of self-harm or harm to others * Severe cognitive impairment, progressive neuromuscular disease * Pregnant and breastfeeding women * Life expectancy of less than 6 months * Pregnant and breastfeeding women * Inability to cooperate with pulmonary function tests * Inability to complete the entire follow-up period * Vulnerable populations other than the elderly, including individuals with mental illness, cognitive impairment, critically ill patients, illiterate individuals, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period | Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training | Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period will be accessed as the primary endpoint. Acute exacerbation of COPD is defined according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of COPD" 2023 version. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days to first Moderate-to-Severe Acute Exacerbation | Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training | Time from baseline to the occurrence of the first acute exacerbation in days. |
| COPD Assessment Test (CAT) Score | Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training | Self-reported measure of health status in COPD patients, assessed using the CAT questionnaire. Higher scores indicate a greater impact of COPD on daily life. |
| Modified Medical Research Council (mMRC) Dyspnea Score | Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training | Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity. |
| St. George's Respiratory Questionnaire (SGRQ) Score | assessed only during the last two follow ups (6 months and 12 months). | Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life. |
Countries
China
Contacts
CONTACTYiqing Xu, MPH, MSRC
CONTACTHuiqing Ge, MD
PRINCIPAL_INVESTIGATORHuiqing Ge, MD
Sir Run Run Shaw Hospital
Outcome results
None listed