Real World App-based CCAAP Management of Children With Asthma

Not Applicable

Not yet recruiting

• Conditions: Asthma
• Interventions: Other: App-based CCAAP; Other: Written CCAAP

• Registration Number: NCT06112405
• Lead Sponsor: Beijing Children's Hospital

Brief Summary

This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to compare the App-based efficacy of China Children Asthma Action Plan (CCAAP) and written CCAAP used in management of children with asthma. The main questions are:1. Is the App-based CCAAP effective/feasible in management of children with asthma? 2. Is the App-based CCAAP better than written CCAAP in management of children with asthma?

Detailed Description

The study is a multi-center randomized control study.The enrollment period is 3 months. Patients who is in 6-17 years of age will be randomized recruited into two groups: the App-based asthma action plan group and the written CCAAP group. Patients in App 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 written CCAAP 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 400 cases for each group from ten children's hospitals. The study will be completed in a year.

Study Timeline

• Study First Submitted: 2023-09-18
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Study Start: 2023-11-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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 well 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App-based CCAAP	App-based CCAAP	Patients in this group will be provided App-based CCAAP to remind them take medicine regularly and direct them what to do when asthma get worse.
written CCAAP	Written CCAAP	Patients in this group will be provided written asthma action plan and direct them what to do when asthma get worse.

Primary Outcome Measures

Name	Time	Method
number of asthma exacerbation	12 months	unscheduled clinics, emergency visiting, hospitalization, absent of school