Clinical Study on Chinese Children's Asthma Action Plan

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.

Study Overview

• Status: Unknown
• Conditions: Asthma in Children
• Intervention / Treatment: Other: asthma action plan management group; Other: conventional management group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: asthma action plan management group; Patients will follow the directions in asthma action plan when their asthma get worse.; Other Names: conventional management group
Other: conventional management group; Patients in this group will be provided conventional management method with prescriptions and asthma diaries.	Other: conventional management group; Patients will follow the directions in conventional strategy when their asthma get worse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of acute episodes of asthma	number of acute episodes of asthma in a year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of FEV1 before and after management	the changes of FEV1 before and after management in a year	1 year
the score of children's quality of life	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.	1 year
asthma knowledge	Knowledge, attitude and practice(KAP) questionnaire，contains 27 questions. Multivariate analysis will be carry out based on the answers to questions	1 year
ACT / C-ACT score	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	1 year
the absent days of school	the number of absent days of school because of asthma attack	1 year
the absent days of parents' work	the number of absent days of parents' work because of children's asthma attack	1 year
the cost of health economics	the cost of acute asthma exacerbation in a year	1 year
the number of unscheduled medical care	the number of unscheduled medical care in a year	1 year

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital
• Collaborators: Peking University Third Hospital; Beijing Tsinghua Chang Gung Hospital; Tianjin Medical University Second Hospital; Tangshan Maternal and Child Health Hospital; The First Hospital of Qinhuangdao; Children's Hospital of Hebei Province; Capital Institute of Pediatrics, China; Tian Jing Children's Hospital; Peking University Bin Hai Hospital
• Investigators: Principal Investigator: kunling Shen, MD,PhD, Beijing Children's Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 22, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: China; children; asthma; action plan; CCAAP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: BCHlung009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make individual participant available to other researchers so far.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No