Clinical Study on Chinese Children's Asthma Action Plan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- number of acute episodes of asthma
研究概览
简要总结
This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management.
详细描述
Asthma is the most common chronic illness of childhood. Asthma action plans have been recommended internationally for more than 20 years by the Global Initiative for Asthma and have been shown to improve asthma-related outcomes. The first asthma action plan for children with asthma in China, which is termed China Children Asthma Action Plan（CCAAP）, as well as a mobile phone-based asthma self management application(APP), were developed recently.
The objective of the study is to assess the efficacy of CCAAP in asthma management.
The study is a multi-center prospective case-controlled study.The enrollment period is 3 months. Patients who is in 6-14 years of age will be randomized recruited into two groups: the asthma action plan group and the conventional group. Patients in asthma action plan group will receive written CCAAP and mobile phone-based asthma self-management APP (Youran Respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and Peak Expiratory Flow Meter. Patients in conventional management group will write down the symptoms and PEF in asthma diary. The data of the number of asthma episodes, the improvement of FEV1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, ACT / C-ACT score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of CCAAP in asthma management. The study will recruit 200 cases for each group from ten children's hospitals. The study will be completed in a year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •did not receive control treatment or did not reach well-control;
- •can perform spirometry pulmonary function tests;
- •parents are skilled in using smartphones and APP apps (Android or IOS).
排除标准
- •reach the level of asthma control;
- •can not use the smartphone APP software;
- •can not cooperate the test of peak expiratory flow;
- •did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);
- •combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).
- •receiving allergen-specific immunotherapy.
- •undergoing trial for other medications or instruments.
研究组 & 干预措施
asthma action plan management group
Patients in this group will be provided both written asthma action plan and mobile-based APP to remind them take medicine regularly and direct them what to do when asthma get worse.
干预措施: asthma action plan management group (Other)
conventional management group
Patients in this group will be provided conventional management method with prescriptions and asthma diaries.
干预措施: conventional management group (Other)
结局指标
主要结局
number of acute episodes of asthma
时间窗: 1 year
number of acute episodes of asthma in a year
次要结局
- the absent days of parents' work(1 year)
- the score of children's quality of life(1 year)
- ACT / C-ACT score(1 year)
- the number of unscheduled medical care(1 year)
- the cost of health economics(1 year)
- asthma knowledge(1 year)
- the changes of FEV1 before and after management(1 year)
- the absent days of school(1 year)
研究者
Kunling Shen
Chief of China National Clinical Research Center for Respiratory Diseases
Beijing Children's Hospital