Pediatric Asthma Control Under Community Management Model in China

Shanghai Jiao Tong University

Status: Unknown

Conditions: Asthma

Treatments: Behavioral: asthma APP

Study type: Interventional

Funder types: Other

Identifiers

NCT02649803

ESR-15-10989

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Out-patient, female or male, aged less than 18 years old
2. Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children"
3. Consent should be obtained by subjects' guardian
4. The subjects or subjects' caregiver must have a smart phone at their disposal

Exclusion criteria

1. Presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc.
2. Allergy to any inhaler cortical steroid
3. Subject with other diseases that may interfere the study results judged by the investigators.
4. Participation in any analogous clinical study within 3 months

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

community hospital

Other group

Description:

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.

Treatment:

Behavioral: asthma APP