Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-01 @ 8:23 AM
Study NCT ID:
NCT01918293
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult
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'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-26', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-08-06', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of smartphone application for asthma control test (ACT)and quality of life', 'timeFrame': 'at least 2 times a week', 'description': 'Using ACT and ALQL score (QoL), we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group'}], 'secondaryOutcomes': [{'measure': 'FEV1 (Forced expiratory volume in 1 second ) and FVC (Forced vital capacity)', 'timeFrame': 'at least 1 time a month', 'description': 'Using spirometer to check the variation of FEV1,we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group'}, {'measure': 'Acute exacerbation of bronchial asthma', 'timeFrame': 'at least 1 time a week', 'description': 'Using medical record and questionaire of acute exacerbation,we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASTHMA', 'SMARTPHONE APPLICATION'], 'conditions': ['BRONCHIAL ASTHMA']}, 'descriptionModule': {'briefSummary': 'Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. In addition, it make large amount of socioeconomic loss as about 3.7 billion US dollars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* using smartphone\n* alleged bronchial asthma over 3months \\& positive of bronchodilator response test or bronchial provocation test\n\nExclusion Criteria:\n\n* COPD\n* active pulmonary TUBERCULOSIS\n* Acute exacerbation within 4weeks\n* severe psychological disorder\n* severe systemic disease; severe LC, ESRD ...\n* MALIGNANCY'}, 'identificationModule': {'nctId': 'NCT01918293', 'briefTitle': 'Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma) in Adult', 'orgStudyIdInfo': {'id': 'SMART-ASTHMA (ADULT)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMART arm', 'description': 'Using smartphone application for control of asthma', 'interventionNames': ['Device: SMART ARM']}, {'type': 'NO_INTERVENTION', 'label': 'conventional arm', 'description': 'non-using smartphone application for control asthma'}], 'interventions': [{'name': 'SMART ARM', 'type': 'DEVICE', 'otherNames': ['SMART-Asthma'], 'description': 'The smartphone application for self-management of Asthma offers symptom diary, general information for asthma, the information of asthma drugs,the guideline for inhaler and the specific action plan according to daily symptom and FEV1.', 'armGroupLabels': ['SMART arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '612-896', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study principal investigator', 'investigatorFullName': 'Jongha Park', 'investigatorAffiliation': 'Inje University'}}}}