- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02649803
Pediatric Asthma Control Under Community Management Model in China
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200127
- Shanghai Children's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: community hospital
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
asthma control questionnaire
Time Frame: 1 year
|
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.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
asthma control test
Time Frame: 1 year
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FENO tests
Time Frame: 1 year
|
Subjects will receive FENO(Fractional exhaled nitric oxide, parts per billion, ppb) tests for evaluation of lung inflammation level.
|
1 year
|
PEF (>5 years old)
Time Frame: 1 year
|
Subjects(older than 5 years) will receive PEF (Peak expiratory flow, L/min) tests for evaluation of lung function.
|
1 year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESR-15-10989
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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