NCT06112405

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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

November 25, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

September 18, 2023

Last Update Submit

October 31, 2023

Conditions

Keywords

asthmachildrenaction planApp-based

Outcome Measures

Primary Outcomes (1)

  • number of asthma exacerbation

    unscheduled clinics, emergency visiting, hospitalization, absent of school

    12 months

Study Arms (2)

App-based CCAAP

OTHER

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

written CCAAP

OTHER

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

Other: Written CCAAP

Interventions

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

App-based CCAAP

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

written CCAAP

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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);

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Maigeng Zhou

    Center of Diseases Control and Prevention, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2023

First Posted

November 1, 2023

Study Start

November 25, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share