Real World App-based CCAAP Management of Children With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112405
• Other study ID #: BeijingChildrens
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 25, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Beijing Children's Hospital
• Contact: Ju Yin
• Phone: 8613366970559
• Email: yinjucw[@]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 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 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 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• App-based CCAAP
App-based CCAAP, could remind patients take controller and reliever when asthma symptoms get worse through mobile.
• Written CCAAP
Written CCAAP, conventional management for patients with asthma, remind them take controller and reliever when asthma symptoms get worse.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Children's Hospital	Capital Institute of Pediatrics, China, Centers for Disease Control and Prevention, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of asthma exacerbation	unscheduled clinics, emergency visiting, hospitalization, absent of school	12 months