Real World App-based CCAAP Management of Children With Asthma

October 31, 2023 updated by: Kunling Shen, Beijing Children's Hospital

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of asthma exacerbation
Time Frame: 12 months
unscheduled clinics, emergency visiting, hospitalization, absent of school
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Collaborators

Centers for Disease Control and Prevention, China
Capital Institute of Pediatrics, China

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 25, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingChildrens

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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