Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,456
- 试验地点
- 1
- 主要终点
- Effectiveness
研究概览
简要总结
This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.
详细描述
COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China.
The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statisticians and outcome assessors will be blinded
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥40 years
- •Post-bronchodilator FEV1/FVC <70%
- •Baseline CAT score ≥10 or history of exacerbation in previous 12 months, defined as any use of oral antibiotics and/or oral or nebulized corticosteroids for increased cough, sputum and dyspnea, or exacerbation requiring hospitalization/ emergency admission.
- •Local residents who live nearby and can be followed up throughout study period
- •Written informed consent
排除标准
- •Pregnancy, breastfeeding, or potential pregnancy
- •Primary diagnosis of asthma
- •Having severe cognitive dysfunction
- •Severely ill with less than 12-month life expectancy
- •Patients with alcohol abuse history are excluded as alcoholic individuals may have low adherence to the study. Alcohol abuse is defined as an average alcohol intake >80 g per day within recent two weeks, or daily intake of ≥40 g alcohol in men, and ≥20 g alcohol in women for more than 5 years.
- •Have participated in similar trials or are undergoing other clinical trials
- •Refuses or unable to give informed consent
- •Plan to move
- •Contraindicated to maintenance medicine.
- •Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry.
- •Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months.
- •Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment
- •Recent exacerbation treated with antibiotics and/or oral or nebulized corticosteroids within 30 days prior to enrolment.
- •Exacerbation requiring emergency admission or hospitalization within 30 days prior to enrolment.
结局指标
主要结局
Effectiveness
时间窗: 12 months from baseline
The primary outcome is annual rate of moderate and severe exacerbation, which will be identified from medical records on the HIS system and patient report at 6 and 12 months assessments
次要结局
- Exacerbation events(12 months from baseline)
- Hospital readmissions(12 months from baseline)
- Hospital stay(12 months from baseline)
- Healthcare cost(12 months from baseline)
- Lung function change(12 months from baseline)
- Symptom change(12 months from baseline)
- Patients' care-seeking behaviors(12 months from baseline)
- Patients' adherence to treatment(12 months from baseline)
研究者
Chen Wang
Principal investigator
China-Japan Friendship Hospital