NCT03435822

Clinical Study on Chinese Children's Asthma Action Plan

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Beijing Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
OTHER	asthma action plan management group	Patients will follow the directions in asthma action plan when their asthma get worse.
OTHER	conventional management group	Patients will follow the directions in conventional strategy when their asthma get worse.

Timeline

• Start date: 2018-03-22
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2018-02-19
• Last updated: 2018-03-20