NCT06112405

Real World App-based CCAAP Management of Children With Asthma

Evaluation of App-based Management of Children's Asthma Based on Real World Data and Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Beijing Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	App-based CCAAP	App-based CCAAP, could remind patients take controller and reliever when asthma symptoms get worse through mobile.
OTHER	Written CCAAP	Written CCAAP, conventional management for patients with asthma, remind them take controller and reliever when asthma symptoms get worse.

Timeline

• Start date: 2023-11-25
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-11-01
• Last updated: 2023-11-01