Pediatric Asthma Control Under Community Management Model in China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn the pediatric asthma control status under community management model. To learn the differences of pediatric asthma control status when subjects assigned to community hospitals or Shanghai Childrens Medical Centre. To learn the treatment adherence and the frequency of asthma attack under community management model.

Detailed Description
-----------------
Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as baseline medical condition will be collected by the investigators. Asthma medicine will be prescribed by the investigator according to patient's asthma severity and control status. The subject will be assigned to the nearest community hospital or Shanghai Children's Medical Center, whichever is nearer to the subject's home, for their future onsite visits. The patient's caregiver will be instructed to install the study-specified application program (APP) at their smart phone and learn how to use this APP. During the study, patients will receive 12 months standard treatment, prescribed by the investigators according to Guideline for the diagnosis and optimal management of asthma in children. The patients' caregiver will be prompted to fill out an asthma control questionnaire and asthma control test via their smart phone APP every month. Patients will be requested to visit prearranged community hospitals at month 1, 3, 6, 9 and arrange their last visit back to Shanghai Children's Medical Center at month 12. During each onsite visit, asthma-related information will be collected by the investigators. Meanwhile, subjects will receive PEF (>5 years old) and FENO tests for evaluation of lung function and inflammation level. After comprehensive assessment of the patient's symptom control, risk factors, occurrence of exacerbations, and practical issues (cost, ability to use the device, and adherence), the investigator will make the decision on whether stepping up or stepping down asthma treatment. This study ends up without follow-up.

Official Title
-----------------
Pediatric Asthma Control Under Community Management Model in China

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: asthma APP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-patient, female or male, aged less than 18 years old Diagnosed as asthma according to Guideline for the diagnosis and optimal management of asthma in children Consent should be obtained by subjects' guardian The subjects or subjects' caregiver must have a smart phone at their disposal Exclusion Criteria: Presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc. Allergy to any inhaler cortical steroid Subject with other diseases that may interfere the study results judged by the investigators. Participation in any analogous clinical study within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: community hospital<br>During the study, subjects who diagnosed as asthma according to Guideline for the diagnosis and optimal management of asthma in children will be assigned to the nearest community hospital or Shanghai Children's Medical Center, and receive 12 months standard treatment, prescribed by the investigators according to Guideline for the diagnosis and optimal management of asthma in children. The patient's caregiver will be instructed to install asthma APP at their smart phone to follow up. | Behavioral: asthma APP<br>* Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the nearest community hospital or Shanghai Children's Medical Center, whichever is nearer to the subject's home, for their future onsite visits (V2-V5). The patient's caregiver will be instructed to install the asthma APP at their smart phone and learn how to use this APP.<br>* Other names: study-specified asthma application program;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma control questionnaire | The patients' caregiver will be prompted to fill out an asthma control questionnaire via their smart phone APP every month. This questionnaire contains questions regarding renewal of prescription, adherence, control status, asthma attack and health economic information. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma control test | caregiver will also be asked to fill out an asthma control test (for patients 12 years or older) , childhood asthma control test (for patients aged 5-12) , or GINA assessment of asthma control in children 5 years and younger. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, asthma control, community