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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital therapy intervention group | Experimental | 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. |
|
| General management group | No Intervention | Patients will accept regular inhaler medication direction, and equipped with electronic inhalation monitoring that can only record medication using data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full process digital therapy intervention package | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| severe exacerbation | Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| First Second Forced Expiratory Volume/ Forced Vital Capacity | First Second Forced Expiratory Volume/Forced Vital Capacity (FEV1/FVC) measured by pulmonomete, % | 12 month |
| First Second Forced Expiratory Volume percentage of estimated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Wu, MD | Contact | 86+15827502015 | wuhanna0506@163.com | |
| Hongtao Niu, PhD | Contact | 86+15810610306 | oxhongtao@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongtao Niu, PhD | China Japan Friendshi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
First Second Forced Expiratory Volume (FEV1) percentage of estimated measured by pulmonomete, %
| 12 month |
| peak expiratory flow | peak expiratory flow (PEF) measured by pulmonomete, L/min | 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. | 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. | 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. | 12 month |
| peak inspiratory flow rate | peak inspiratory flow rate (PIFR) measured by the sensor in the study | 12 month |
| mild and moderate exacerbation | Proportion of patients with mild and moderate acute exacerbation of COPD pulmonary disease during the follow-up period. | 12 month |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |