A Multicenter Open-label Randomized Controlled Trial of Social Media-based Bundle Care in Patients With Exacerbation of Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 648
- 主要终点
- Readmission rate due to acute exacerbation of COPD within one year
研究概览
简要总结
Chronic obstructive pulmonary disease(COPD) is an incompletely reversible and progressive pulmonary disease characterized by airflow restriction, which is the third leading cause of death worldwide, accounting for 6% of all deaths worldwide. Acute exacerbation (AE) of COPD can accelerate the decline of lung function, worsening pulmonary symptoms, and increase the risk of death in patients. Health education, inhaled technical guidance training, individual self-management, psychological counseling, home oxygen therapy, nutritional support, and other comprehensive interventions can help improve the lung function of COPD patients, alleviate clinical symptoms, improve the quality of life. While a number of COPD applications have been developed, few provide comprehensive assessment and guidance for these kinds of patients. Therefore, the investigators aim to establish a bundle care mode based on the mode of "hospital-home-community-patient", clarify the impact of the management on prognosis, and evaluate the effect of mobile medical-assisted bundle management mode. In this randomized controlled trial(RCT), AECOPD patients will be divided into interventional or control groups randomly. Patients in the interventional group will receive mobile medication and standard of care at the same time (bundle care mode). While patients in the control group will receive standard of care only (traditional management mode). This study will be conducted to compare the effects of traditional and bundle care modes, and to formulate the implementation path and specifications of bundle care for AECOPD patients after discharge in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AECOPD Patients with pulmonary function grade GOLD2-4;
- •Aged between 45 and 70 years old;
- •Have a smartphone, and can skillfully use mobile Wechat official account;
- •Willing to use Wechat official accounts to manage COPD;
- •Willing to accept outpatient follow-up;
- •Signed informed consent.
排除标准
- •Patients with asthma, bronchiectasis, tuberculosis, or other diseases;
- •Patients with malignant tumors, liver and kidney failure, limb dyskinesia, and other diseases;
- •Unstable angina pectoris in recent one month, myocardial infarction within a half year, severe arrhythmia, uncontrollable congestive heart failure, or poor blood pressure control (systolic blood pressure > 140mmHg and/or diastolic blood pressure > 90mmHg);
- •Cognitive impairment;
- •Combined with respiratory failure;
- •With a life expectancy of less than one year;
- •Plan to or participating in a COPD management project or mobile Wechat official account project;
- •Completed another trial within 30 days.
结局指标
主要结局
Readmission rate due to acute exacerbation of COPD within one year
时间窗: One year
Collected within one year after discharge
次要结局
- The time interval from discharge to the next acute exacerbation of COPD(One year)
- The times of acute exacerbation of COPD(One year)
- Average annual medical cost(One year)
- The score of subjective symptom(One year)
- Compliance index(One year)
- The changes of spirometry(One year)
- The changes of percent of eosinophil count(One year)
- The changes of arterial blood gas analysis(One year)
- The types and proportions of adverse events occurred during using WeChat official account.(One year)
研究者
Yingxiang Lin
Chief physician of Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University,
Beijing Chao Yang Hospital