Clinical Study on Chinese Children's Asthma Action Plan
Primary Purpose
Asthma in Children
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
asthma action plan management group
conventional management group
Sponsored by

About this trial
This is an interventional treatment trial for Asthma in Children focused on measuring asthma, children, action plan, China, CCAAP
Eligibility Criteria
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
asthma action plan management group
conventional management group
Arm Description
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.
Patients in this group will be provided conventional management method with prescriptions and asthma diaries.
Outcomes
Primary Outcome Measures
number of acute episodes of asthma
number of acute episodes of asthma in a year
Secondary Outcome Measures
the changes of FEV1 before and after management
the changes of FEV1 before and after management in a year
the score of children's quality of life
pediatric asthma quality of life questionnaire contains 23 items in three domains, activity limitation(10), symptoms(5) and emotional function(8). The scale from 1-7 for each question. And the higher score the better quality of life.
asthma knowledge
Knowledge, attitude and practice(KAP) questionnaire,contains 27 questions. Multivariate analysis will be carry out based on the answers to questions
ACT / C-ACT score
the change of ACT / C-ACT score. there are 5 questions. For each questions, score ranks from 1 to five. Total score 25: well control, 20~24: control, less than 20: un ncontrol
the absent days of school
the number of absent days of school because of asthma attack
the absent days of parents' work
the number of absent days of parents' work because of children's asthma attack
the cost of health economics
the cost of acute asthma exacerbation in a year
the number of unscheduled medical care
the number of unscheduled medical care in a year
Full Information
NCT ID
NCT03435822
First Posted
February 12, 2018
Last Updated
March 16, 2018
Sponsor
Beijing Children's Hospital
Collaborators
Tian Jing Children's Hospital, Capital Institute of Pediatrics, China, Peking University Third Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University Second Hospital, Peking University Bin Hai Hospital, The First Hospital of Qinhuangdao, Tangshan Maternal and Child Health Hospital, Children's Hospital of Hebei Province
1. Study Identification
Unique Protocol Identification Number
NCT03435822
Brief Title
Clinical Study on Chinese Children's Asthma Action Plan
Official Title
Clinical Study on Chinese Children's Asthma Action Plan
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Children's Hospital
Collaborators
Tian Jing Children's Hospital, Capital Institute of Pediatrics, China, Peking University Third Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University Second Hospital, Peking University Bin Hai Hospital, The First Hospital of Qinhuangdao, Tangshan Maternal and Child Health Hospital, Children's Hospital of Hebei Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management.
Detailed Description
Asthma is the most common chronic illness of childhood. Asthma action plans have been recommended internationally for more than 20 years by the Global Initiative for Asthma and have been shown to improve asthma-related outcomes. The first asthma action plan for children with asthma in China, which is termed China Children Asthma Action Plan(CCAAP), as well as a mobile phone-based asthma self management application(APP), were developed recently.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
asthma, children, action plan, China, CCAAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
asthma action plan management group
Arm Type
Other
Arm Description
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.
Arm Title
conventional management group
Arm Type
Other
Arm Description
Patients in this group will be provided conventional management method with prescriptions and asthma diaries.
Intervention Type
Other
Intervention Name(s)
asthma action plan management group
Other Intervention Name(s)
conventional management group
Intervention Description
Patients will follow the directions in asthma action plan when their asthma get worse.
Intervention Type
Other
Intervention Name(s)
conventional management group
Intervention Description
Patients will follow the directions in conventional strategy when their asthma get worse.
Primary Outcome Measure Information:
Title
number of acute episodes of asthma
Description
number of acute episodes of asthma in a year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
the changes of FEV1 before and after management
Description
the changes of FEV1 before and after management in a year
Time Frame
1 year
Title
the score of children's quality of life
Description
pediatric asthma quality of life questionnaire contains 23 items in three domains, activity limitation(10), symptoms(5) and emotional function(8). The scale from 1-7 for each question. And the higher score the better quality of life.
Time Frame
1 year
Title
asthma knowledge
Description
Knowledge, attitude and practice(KAP) questionnaire,contains 27 questions. Multivariate analysis will be carry out based on the answers to questions
Time Frame
1 year
Title
ACT / C-ACT score
Description
the change of ACT / C-ACT score. there are 5 questions. For each questions, score ranks from 1 to five. Total score 25: well control, 20~24: control, less than 20: un ncontrol
Time Frame
1 year
Title
the absent days of school
Description
the number of absent days of school because of asthma attack
Time Frame
1 year
Title
the absent days of parents' work
Description
the number of absent days of parents' work because of children's asthma attack
Time Frame
1 year
Title
the cost of health economics
Description
the cost of acute asthma exacerbation in a year
Time Frame
1 year
Title
the number of unscheduled medical care
Description
the number of unscheduled medical care in a year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kunling Shen, MD,PhD
Phone
59616666
Ext
6308
Email
kunlingshen1717@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kunling Shen, MD,PhD
Organizational Affiliation
Beijing Children's Hospital of Capital Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant available to other researchers so far.
Learn more about this trial
Clinical Study on Chinese Children's Asthma Action Plan
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