Pediatric Asthma Control Under Community Management Model in China

Asthma Clinical Trial

Official title:

Pediatric Asthma Control Under Community Management Model in China

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02649803
• Other study ID #: ESR-15-10989
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 1, 2016
• Last updated: August 12, 2016
• Start date: March 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2016
• Source: Shanghai Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: June 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai children's medical center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FENO tests	Subjects will receive FENO(Fractional exhaled nitric oxide, parts per billion, ppb) tests for evaluation of lung inflammation level.	1 year	No
Other	PEF (>5 years old)	Subjects(older than 5 years) will receive PEF (Peak expiratory flow, L/min) tests for evaluation of lung function.	1 year	No
Primary	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	No
Secondary	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	No