Early Warning Value of Consumer Wearable Devices in AECOPD

COPD Clinical Trial

— EWVCWDC  

Official title:

Early Warning Value of Consumer Wearable Devices in Chronic Obstructive Pulmonary Disease Exacerbation: An Evaluation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974670
• Other study ID #: 2021397-20220703
• Status: Recruiting
• Start date: June 21, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: Peking University First Hospital
• Contact: Jiping Liao, MD.
• Phone: 13521714181
• Email: colorfulwing01[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with stable COPD (refer to 2021 GOLD guidelines);
• Age between 35 and 80 years (both 35 and 80), either gender;
• A post-bronchodilator forced expiratory volume in 1 second percentage (FEV1%) predicted between 25%~80%;
• Having mobile phone which can install APP of wearable device;
• Able to engage in daily activities;

Exclusion Criteria:

• History of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
• History of lobectomy and/or lung transplantation;
• Predicted life expectancy less than 3 years;
• History of serious underlying diseases (including severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease);
• Alcoholism, drug or toxic solvents abuse;
• Moderate to severe anemia;
• Smoking or quitting smoking for less than 6 weeks;
• Skin pigmentation, deformity, arterial stenosis or occlusion of both upper limbs;
• Skin allergy to metal/plastic;
• Those who are participating in other clinical trials, cannot be followed up for a long time or have poor compliance.

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
China	Aerospace 731 Hospital	Beijing	Beijing
China	Beijing Miyun Hospital	Beijing	Beijing
China	Civil Aviation General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	People's Hospital of Beijing Daxing District	Beijing	Beijing
China	Shichahai Community Health Service Center	Beijing	Beijing
China	The Hospital of Shunyi District Beijing	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood oxygen saturation	A wearable device worn by the subject continuously monitors blood oxygen saturation.	6 months
Secondary	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
Secondary	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
Secondary	Wearing compliance	Compliance is defined as the ratio of the time of wearing a device to the total study time.	6 months
Secondary	Data loss rate	Data loss rate	6 months