An observational study in COPD, sponsored by Peking University First Hospital. Status unknown at 7 sites in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Peking University First Hospital · Observational
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 150 is below the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Peking University First Hospital is the lead sponsor of 386 studies on the registry; 182 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients and inpatients from Peking University First Hospital
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Exclusion Criteria:
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.
Device: Consumer wearable 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.
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.
Time frame: 6 months
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.
Time frame: 6 months
Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)
The change in mMRC score is calculated by the difference in CAT score during follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Blood oxygen saturation
A wearable device worn by the subject continuously monitors blood oxygen saturation.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Wearing compliance
Compliance is defined as the ratio of the time of wearing a device to the total study time.
Time frame: 6 months
Data loss rate
Data loss rate
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Sep 2023, 15 months after the start.
Of 330 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's planned 15 months is below that.
Counting every sponsor, half of 429 studies reached it within 28 months; a quarter within 16 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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