Clinical Study on Chinese Children's Asthma Action Plan
NCT ID: NCT03435822
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2018-03-22
2019-06-30
Brief Summary
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Detailed Description
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The objective of the study is to assess the efficacy of CCAAP in asthma management.
The study is a multi-center prospective case-controlled study.The enrollment period is 3 months. Patients who is in 6-14 years of age will be randomized recruited into two groups: the asthma action plan group and the conventional group. Patients in asthma action plan 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 conventional 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 200 cases for each group from ten children's hospitals. The study will be completed in a year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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asthma action plan management group
Patients in this group will be provided both written asthma action plan and mobile-based APP to remind them take medicine regularly and direct them what to do when asthma get worse.
asthma action plan management group
Patients will follow the directions in asthma action plan when their asthma get worse.
conventional management group
Patients in this group will be provided conventional management method with prescriptions and asthma diaries.
conventional management group
Patients will follow the directions in conventional strategy when their asthma get worse.
Interventions
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asthma action plan management group
Patients will follow the directions in asthma action plan when their asthma get worse.
conventional management group
Patients will follow the directions in conventional strategy when their asthma get worse.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* can perform spirometry pulmonary function tests;
* parents are skilled in using smartphones and APP apps (Android or IOS).
Exclusion Criteria
* 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.
6 Years
14 Years
ALL
No
Sponsors
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Tian Jing Children's Hospital
UNKNOWN
Capital Institute of Pediatrics, China
OTHER
Peking University Third Hospital
OTHER
Beijing Tsinghua Chang Gung Hospital
OTHER
Tianjin Medical University Second Hospital
OTHER
Peking University Bin Hai Hospital
UNKNOWN
The First Hospital of Qinhuangdao
OTHER_GOV
Tangshan Maternal and Child Health Hospital
OTHER
Children's Hospital of Hebei Province
OTHER
Beijing Children's Hospital
OTHER
Responsible Party
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Kunling Shen
Chief of China National Clinical Research Center for Respiratory Diseases
Principal Investigators
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kunling Shen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Children's Hospital of Capital Medical University
Central Contacts
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Other Identifiers
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BCHlung009
Identifier Type: -
Identifier Source: org_study_id
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