Clinical Study on Chinese Children's Asthma Action Plan

Asthma in Children Clinical Trial

Official title:

Clinical Study on Chinese Children's Asthma Action Plan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03435822
• Other study ID #: BCHlung009
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2018
• Last updated: March 16, 2018
• Start date: March 22, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2018
• Source: Beijing Children's Hospital
• Contact: Kunling Shen, MD,PhD
• Phone: 59616666
• Email: kunlingshen1717[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• asthma action plan management group
Patients will follow the directions in asthma action plan when their asthma get worse.
• conventional management group
Patients will follow the directions in conventional strategy when their asthma get worse.

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Beijing Children's Hospital	Beijing Tsinghua Chang Gung Hospital, Capital Institute of Pediatrics, China, Children's Hospital of Hebei Province, Peking University Bin Hai Hospital, Peking University Third Hospital, Tangshan Maternal and Child Health Hospital, The First Hospital of Qinhuangdao, Tian Jing Children’s Hospital, Tianjin Medical University Second Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of acute episodes of asthma	number of acute episodes of asthma in a year	1 year
Secondary	the changes of FEV1 before and after management	the changes of FEV1 before and after management in a year	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	the absent days of school	the number of absent days of school because of asthma attack	1 year
Secondary	the absent days of parents' work	the number of absent days of parents' work because of children's asthma attack	1 year
Secondary	the cost of health economics	the cost of acute asthma exacerbation in a year	1 year
Secondary	the number of unscheduled medical care	the number of unscheduled medical care in a year	1 year