Real World App-based CCAAP Management of Children With Asthma

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06112405
Collaborator
Capital Institute of Pediatrics, China (Other), Centers for Disease Control and Prevention, China (Other)
400
2
13.2

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: App-based CCAAP
  • Other: Written CCAAP
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of App-based Management of Children's Asthma Based on Real World Data and Randomized Control Trial
Anticipated Study Start Date :
Nov 25, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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

Other: written CCAAP

Patients in this group will be provided written asthma action plan and direct them what to do when asthma get worse.

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

Outcome Measures

Primary Outcome Measures

  1. number of asthma exacerbation [12 months]

    unscheduled clinics, emergency visiting, hospitalization, absent of school

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Maigeng Zhou, Center of Diseases Control and Prevention, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kunling Shen, Professor, Beijing Children's Hospital
ClinicalTrials.gov Identifier:
NCT06112405
Other Study ID Numbers:
  • BeijingChildrens
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kunling Shen, Professor, Beijing Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2023