Clinical Study on Chinese Children’s Asthma Action Plan

Overview

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.

Full Title of Study: “Clinical Study on Chinese Children’s Asthma Action Plan”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: 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.
  • Other: conventional management group
    • Patients in this group will be provided conventional management method with prescriptions and asthma diaries.

Clinical Trial Outcome Measures

Primary Measures

  • number of acute episodes of asthma
    • Time Frame: 1 year
    • number of acute episodes of asthma in a year

Secondary Measures

  • the changes of FEV1 before and after management
    • Time Frame: 1 year
    • the changes of FEV1 before and after management in a year
  • the score of children’s quality of life
    • Time Frame: 1 year
    • pediatric asthma quality of life questionnaire contains 23 items in three domains, activity limitation(10), symptoms(5) and emotional function(8). The scale from 1-7 for each question. And the higher score the better quality of life.
  • asthma knowledge
    • Time Frame: 1 year
    • Knowledge, attitude and practice(KAP) questionnaire,contains 27 questions. Multivariate analysis will be carry out based on the answers to questions
  • ACT / C-ACT score
    • Time Frame: 1 year
    • the change of ACT / C-ACT score. there are 5 questions. For each questions, score ranks from 1 to five. Total score 25: well control, 20~24: control, less than 20: un ncontrol
  • the absent days of school
    • Time Frame: 1 year
    • the number of absent days of school because of asthma attack
  • the absent days of parents’ work
    • Time Frame: 1 year
    • the number of absent days of parents’ work because of children’s asthma attack
  • the cost of health economics
    • Time Frame: 1 year
    • the cost of acute asthma exacerbation in a year
  • the number of unscheduled medical care
    • Time Frame: 1 year
    • the number of unscheduled medical care in a year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Children’s Hospital
  • Collaborator
    • Tian Jing Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kunling Shen, Chief of China National Clinical Research Center for Respiratory Diseases – Beijing Children’s Hospital
  • Overall Official(s)
    • kunling Shen, MD,PhD, Principal Investigator, Beijing Children’s Hospital of Capital Medical University
  • Overall Contact(s)
    • Kunling Shen, MD,PhD, 59616666, kunlingshen1717@163.com

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