Clinical trial NCT02649803: Pediatric Asthma Control Under Community Management Model in China
Official title: Pediatric Asthma Control Under Community Management Model in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: pediatric
asthma control
community
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: asthma control questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: asthma control test
timeFrame: 1 year
Other outcomes:
measure: FENO tests
timeFrame: 1 year
measure: PEF (>5 years old)
timeFrame: 1 year
Locations:
city: Shanghai
country: China
facility: Shanghai children's medical center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yong Yin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Zhao L, Zhao D, Chen Z, Li S, Zhang H, Zhang L, Yuan S, Tang M, Wu Y, Zhong W, Xu J, Zhao LX, Liu SY, Hong J, Yin Y. Reliability and validity of the Chinese version of the Test for Respiratory and Asthma Control in Kids (TRACK) in preschool children with asthma: a prospective validation study. BMJ Open. 2019 Aug 26;9(8):e025378. doi: 10.1136/bmjopen-2018-025378.