Effectiveness of DITM Versus IMT in COPD Patients With High Symptom Burden and High Risk of Acute Exacerbation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 9
- 主要终点
- Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Compare Group
The subjects will receive standardized verbal training and demonstration of inhalation techniques. No additional equipment provided
Digital Inhalation Management Group
Digital Inhalation Management Group will receive digital inhaled therapy management only
干预措施: Digital Inhaled Therapy Management (Device)
Inspiratory Muscle Training Group
Inspiratory Muscle Training Group will receive inspiratory muscle training only
干预措施: Inspiratory Muscle Training (Device)
Inhalation Muscle Training Combined with Digital Inhalation Therapy Management Group
The subjects will receive Inspiratory muscle training equipment, ancillary software, inspiratory muscle training plan, and equipment user guide in addition to training on the use of Digital Inhalation Administration device.
干预措施: Digital Inhaled Therapy Management (Device)
Inhalation Muscle Training Combined with Digital Inhalation Therapy Management Group
The subjects will receive Inspiratory muscle training equipment, ancillary software, inspiratory muscle training plan, and equipment user guide in addition to training on the use of Digital Inhalation Administration device.
干预措施: Inspiratory Muscle Training (Device)
结局指标
主要结局
Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period
时间窗: 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.
次要结局
- Days to first Moderate-to-Severe Acute Exacerbation(Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training)
- COPD Assessment Test (CAT) Score(Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training)
- Modified Medical Research Council (mMRC) Dyspnea Score(Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training)
- St. George's Respiratory Questionnaire (SGRQ) Score(assessed only during the last two follow ups (6 months and 12 months).)
研究者
Huiqing Ge
Director of Respiratory Therapy Department, Sir Run Run Shaw Hospital
Sir Run Run Shaw Hospital