Clinical Study on Chinese Children's Asthma Action Plan
Last updated on July 2021Recruitment
- Recruitment Status
- Unknown status
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Asthma in Children
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 14 years
- Gender
- Both males and females
Description
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 i...
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.
Tracking Information
- NCT #
- NCT03435822
- Collaborators
- Tian Jing Children's Hospital
- Capital Institute of Pediatrics, China
- Peking University Third Hospital
- Beijing Tsinghua Chang Gung Hospital
- Tianjin Medical University Second Hospital
- Peking University Bin Hai Hospital
- The First Hospital of Qinhuangdao
- Tangshan Maternal and Child Health Hospital
- Children's Hospital of Hebei Province
- Investigators
- Principal Investigator: kunling Shen, MD,PhD Beijing Children's Hospital of Capital Medical University