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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06112405
Enrollment
400
Registered
2023-11-01
Start date
2023-11-25
Completion date
2024-12-31
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, children, action plan, App-based

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.

Interventions

OTHERApp-based CCAAP

App-based CCAAP, could remind patients take controller and reliever when asthma symptoms get worse through mobile.

OTHERWritten CCAAP

Written CCAAP, conventional management for patients with asthma, remind them take controller and reliever when asthma symptoms get worse.

Sponsors

Capital Institute of Pediatrics, China
CollaboratorOTHER
Centers for Disease Control and Prevention, China
CollaboratorOTHER_GOV
Beijing Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
number of asthma exacerbation12 monthsunscheduled clinics, emergency visiting, hospitalization, absent of school

Contacts

Primary ContactJu Yin
yinjucw@163.com8613366970559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026