Clinical trial NCT03435822: Clinical Study on Chinese Children's Asthma Action Plan
Official title: Clinical Study on Chinese Children's Asthma Action Plan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma in Children
Keywords: asthma
children
action plan
China
CCAAP
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Tian Jing Children's Hospital
name: Capital Institute of Pediatrics, China
name: Peking University Third Hospital
name: Beijing Tsinghua Chang Gung Hospital
name: Tianjin Medical University Second Hospital
name: Peking University Bin Hai Hospital
name: The First Hospital of Qinhuangdao
name: Tangshan Maternal and Child Health Hospital
name: Children's Hospital of Hebei Province
First posted: 2018-02-19
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: number of acute episodes of asthma
timeFrame: 1 year
Secondary outcomes:
measure: the changes of FEV1 before and after management
timeFrame: 1 year
measure: the score of children's quality of life
timeFrame: 1 year
measure: asthma knowledge
timeFrame: 1 year
measure: ACT / C-ACT score
timeFrame: 1 year
measure: the absent days of school
timeFrame: 1 year
measure: the absent days of parents' work
timeFrame: 1 year
measure: the cost of health economics
timeFrame: 1 year
measure: the number of unscheduled medical care
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Children's Hospital of Capital Medical University
name: kunling Shen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: