Effectiveness of DITM Versus IMT in COPD Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorSir Run Run Shaw Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Inhaled Therapy Management
DeviceThe 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.
Inspiratory Muscle Training
DeviceThe 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.
Treatment groups
410 Participants
are divided into 4 treatment groupsGroup A: Digital Inhalation Management GroupExperimental treatment 1 intervention
Group B: Inspiratory Muscle Training GroupExperimental treatment 1 intervention
Group C: Inhalation Muscle Training Combined with Digital Inhalation Therapy Management GroupExperimental treatment 2 interventions
Group D: Compare GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period
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.
Time frame
Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial trainingSecondary outcomes
1
Days to first Moderate-to-Severe Acute Exacerbation
Time from baseline to the occurrence of the first acute exacerbation in days.
Time frame
Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training2
COPD Assessment Test (CAT) Score
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.
Time frame
Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training3
Modified Medical Research Council (mMRC) Dyspnea Score
Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity.
Time frame
Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training4
St. George's Respiratory Questionnaire (SGRQ) Score
Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life.
Time frame
assessed only during the last two follow ups (6 months and 12 months).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sir Run Run Shaw Hospital
Lead sponsor
Jingyao (Hangzhou) Health Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov