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This is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage will be included. Wearable device's physiological parameters will be continually collected, the investigators aim to explore whether consumer wearable devices are useful for early warning deterioration of COPD.
This is a prospective cohort study. 150 subjects aged 35~80y with stable COPD will be recruited. After enrollment, subjects wear consumer wearable devices and install APP on their mobile phones. The first 7 days of wearing are to evaluate the stability of data collection and the subject compliance, and to correct the wrong wearing. The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Primary outcome is the moderate or more severe COPD acute exacerbation events. The purpose of this study is to use consumer wearable devices to monitor the changes of COPD, and to establish a physiological parameters model of wearable device that can predict the acute exacerbation of COPD.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2021-397). Any protocol modifications will be submitted for the IRB review and approval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearing device | The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consumer wearable device | Device | The subjects are required to wear the consumer wearable devices continuously during the whole study period. The device can provided several physiological parameters, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate or more severe COPD exacerbation | Mild exacerbation: exacerbation requiring short-acting bronchodilator (SABD) therapy alone Moderate exacerbation: exacerbation requiring SABD and antimicrobials with or without oral corticosteroids Severe exacerbation: exacerbation requiring hospitalization or emergency, intensive care unit (ICU) treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in symptoms (assessed by COPD Assessment Test, CAT) | The change in CAT score is calculated by the difference in CAT score during follow-up. | 6 months |
| Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores) |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatients and inpatients from Peking University First Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiping Liao, MD. | Contact | 13521714181 | colorfulwing01@163.com | |
| Chunbo Zhang | Contact | 13086645758 | 2399637945@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Guangfa Wang, MD. | Peking University First Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | 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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The change in mMRC score is calculated by the difference in CAT score during follow-up. |
| 6 months |
| Changes in post-bronchodilator FEV1 | Post-bronchodilator FEV1 is measured by trained staff. The change in post-bronchodilator FEV1 is defined as the difference in FEV1 between week 24 follow-up and enrollment. | 6 months |
| Changes in post-bronchodilator FEV1% | Post-bronchodilator FEV1% is measured by trained staff. The change in post-bronchodilator FEV1% is defined as the difference in FEV1 between week 24 follow-up and enrollment. | 6 months |
| Changes in post-bronchodilator FVC | Post-bronchodilator FVC is measured by trained staff. The change in post-bronchodilator FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment. | 6 months |
| Changes in post-bronchodilator FVC% | Post-bronchodilator FVC% is measured by trained staff. The change in post-bronchodilator FVC% is defined as the difference in FEV1 between week 24 follow-up and enrollment. | 6 months |
| Changes in post-bronchodilator FEV1/FVC | Post-bronchodilator FEV1/FVC is measured by trained staff. The change in post-bronchodilator FEV1/FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment. | 6 months |
| Herat rate parameters | A wearable device worn by the subject continuously monitors heart rate parameters, from which parameters such as heart rate can be obtained. | 6 months |
| Blood oxygen saturation | A wearable device worn by the subject continuously monitors blood oxygen saturation. | 6 months |
| Physical parameters from wearable device | A wearable device worn by the subject continuously monitors physical parameters, from which parameters such as steps can be obtained. | 6 months |
| Sleep parameters from wearable device | A wearable device worn by the subject continuously monitors sleep parameters, from which parameters such as sleep duration can be obtained. | 6 months |
| Wearing compliance | Compliance is defined as the ratio of the time of wearing a device to the total study time. | 6 months |
| Data loss rate | Data loss rate | 6 months |
| Aerospace 731 Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Beijing Miyun Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Civil Aviation General Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| People's Hospital of Beijing Daxing District | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Shichahai Community Health Service Center | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The Hospital of Shunyi District Beijing | Not yet recruiting | Beijing | Beijing Municipality | China |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |