Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT02649803
Status:
UNKNOWN
Last Update Posted:
2016-08-15
First Post:
2016-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Asthma Control Under Community Management Model in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2016-01-01', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'FENO tests', 'timeFrame': '1 year', 'description': 'Subjects will receive FENO(Fractional exhaled nitric oxide, parts per billion, ppb) tests for evaluation of lung inflammation level.'}, {'measure': 'PEF (>5 years old)', 'timeFrame': '1 year', 'description': 'Subjects(older than 5 years) will receive PEF (Peak expiratory flow, L/min) tests for evaluation of lung function.'}], 'primaryOutcomes': [{'measure': 'asthma control questionnaire', 'timeFrame': '1 year', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'asthma control test', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatric', 'asthma control', 'community'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '31455696', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring 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".\n\nThe patients\' caregiver will be prompted to fill out an asthma control questionnaire and asthma control test via their smart phone APP every month.\n\nPatients 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.\n\nMeanwhile, 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.\n\nThis study ends up without follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Out-patient, female or male, aged less than 18 years old\n2. Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children"\n3. Consent should be obtained by subjects\' guardian\n4. The subjects or subjects\' caregiver must have a smart phone at their disposal\n\nExclusion Criteria:\n\n1. Presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc.\n2. Allergy to any inhaler cortical steroid\n3. Subject with other diseases that may interfere the study results judged by the investigators.\n4. Participation in any analogous clinical study within 3 months'}, 'identificationModule': {'nctId': 'NCT02649803', 'briefTitle': 'Pediatric Asthma Control Under Community Management Model in China', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Children's Medical Center"}, 'officialTitle': 'Pediatric Asthma Control Under Community Management Model in China', 'orgStudyIdInfo': {'id': 'ESR-15-10989'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'community hospital', '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.', 'interventionNames': ['Behavioral: asthma APP']}], 'interventions': [{'name': 'asthma APP', 'type': 'BEHAVIORAL', 'otherNames': ['study-specified asthma application program'], 'description': "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.", 'armGroupLabels': ['community hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai children's medical center", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yong Yin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}