Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06112405
Status:
UNKNOWN
Last Update Posted:
2023-11-01
First Post:
2023-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World App-based CCAAP Management of Children With Asthma
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of asthma exacerbation', 'timeFrame': '12 months', 'description': 'unscheduled clinics, emergency visiting, hospitalization, absent of school'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'children', 'action plan', 'App-based'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to compare the App-based efficacy of China Children Asthma Action Plan (CCAAP) and written CCAAP used in management of children with asthma. The main questions are:1. Is the App-based CCAAP effective/feasible in management of children with asthma? 2. Is the App-based CCAAP better than written CCAAP in management of children with asthma?', 'detailedDescription': "The study is a multi-center randomized control study.The enrollment period is 3 months. Patients who is in 6-17 years of age will be randomized recruited into two groups: the App-based asthma action plan group and the written CCAAP group. Patients in App group will receive written CCAAP and mobile phone-based asthma self-management APP (Youran Respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and Peak Expiratory Flow Meter. Patients in written CCAAP management group will write down the symptoms and PEF in asthma diary. The data of the number of asthma episodes, the improvement of FEV1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, ACT / C-ACT score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of CCAAP in asthma management. The study will recruit 400 cases for each group from ten children's hospitals. The study will be completed in a year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* did not receive control treatment or did not reach well-control;\n* can perform spirometry pulmonary function tests;\n* parents are skilled in using smartphones and APP apps (Android or IOS);\n\nExclusion Criteria:\n\n* reach the level of asthma well control;\n* can not use the smartphone APP software;\n* can not cooperate the test of peak expiratory flow;\n* did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);\n* combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).\n* receiving allergen-specific immunotherapy.\n* undergoing trial for other medications or instruments.'}, 'identificationModule': {'nctId': 'NCT06112405', 'briefTitle': 'Real World App-based CCAAP Management of Children With Asthma', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': "Evaluation of App-based Management of Children's Asthma Based on Real World Data and Randomized Control Trial", 'orgStudyIdInfo': {'id': 'BeijingChildrens'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'App-based CCAAP', 'description': 'Patients in this group will be provided App-based CCAAP to remind them take medicine regularly and direct them what to do when asthma get worse.', 'interventionNames': ['Other: App-based CCAAP']}, {'type': 'OTHER', 'label': 'written CCAAP', 'description': 'Patients in this group will be provided written asthma action plan and direct them what to do when asthma get worse.', 'interventionNames': ['Other: Written CCAAP']}], 'interventions': [{'name': 'App-based CCAAP', 'type': 'OTHER', 'description': 'App-based CCAAP, could remind patients take controller and reliever when asthma symptoms get worse through mobile.', 'armGroupLabels': ['App-based CCAAP']}, {'name': 'Written CCAAP', 'type': 'OTHER', 'description': 'Written CCAAP, conventional management for patients with asthma, remind them take controller and reliever when asthma symptoms get worse.', 'armGroupLabels': ['written CCAAP']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ju Yin', 'role': 'CONTACT', 'email': 'yinjucw@163.com', 'phone': '8613366970559'}], 'overallOfficials': [{'name': 'Maigeng Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Diseases Control and Prevention, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Capital Institute of Pediatrics, China', 'class': 'OTHER'}, {'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kunling Shen', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}