Early Warning Value of Consumer Wearable Devices in Chronic Obstructive Pulmonary Disease Exacerbation: An Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Moderate or more severe COPD exacerbation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Moderate or more severe COPD exacerbation
时间窗: 6 months
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.
次要结局
- Changes in post-bronchodilator FVC%(6 months)
- Blood oxygen saturation(6 months)
- Changes in symptoms (assessed by COPD Assessment Test, CAT)(6 months)
- Changes in post-bronchodilator FVC(6 months)
- Changes in post-bronchodilator FEV1(6 months)
- Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)(6 months)
- Sleep parameters from wearable device(6 months)
- Changes in post-bronchodilator FEV1%(6 months)
- Physical parameters from wearable device(6 months)
- Changes in post-bronchodilator FEV1/FVC(6 months)
- Herat rate parameters(6 months)
- Wearing compliance(6 months)
- Data loss rate(6 months)