NCT02649803

Pediatric Asthma Control Under Community Management Model in China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
BEHAVIORAL	asthma APP	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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-01-01
• Completion: 2019-06-01
• First posted: 2016-01-07
• Last updated: 2016-08-15

Locations

1 site across 1 country: China