This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
600
Patients will receive individualized inhalation skills guidance after being tested by inhalation capacity measuring device, and be equipped with electronic inhalation monitoring devices, which can record their medication using data, reminding patients to use the medication on time, and correct their inhalation mistake. They can also check their inhalation record on their mobile phones. Clinicians can check the record every month to assess their adherence.
China Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGsevere exacerbation
Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.
Time frame: 12 month
First Second Forced Expiratory Volume/ Forced Vital Capacity
First Second Forced Expiratory Volume/Forced Vital Capacity (FEV1/FVC) measured by pulmonomete, %
Time frame: 12 month
First Second Forced Expiratory Volume percentage of estimated
First Second Forced Expiratory Volume (FEV1) percentage of estimated measured by pulmonomete, %
Time frame: 12 month
peak expiratory flow
peak expiratory flow (PEF) measured by pulmonomete, L/min
Time frame: 12 month
COPD Assessment Test score
COPD assessment test (CAT) is an eight-item questionnaire range from 0 to 40. Higher scroe represents heavier symptom.
Time frame: 12 month
modified Medical Research Council scale
The modified Medical Research Council (mMRC) scale stands for the level of patient self-report dyspnea. 0 is the minimum and 4 is the maximum.
Time frame: 12 month
St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score
the SGRQ scroe range from 0 to 100. 0 represents for the least and 100represents for the most.
Time frame: 12 month
peak inspiratory flow rate
peak inspiratory flow rate (PIFR) measured by the sensor in the study
Time frame: 12 month
mild and moderate exacerbation
Proportion of patients with mild and moderate acute exacerbation of COPD pulmonary disease during the follow-up period.
Time frame: 12 month
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