Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-29 @ 2:21 AM
Study NCT ID:
NCT05972668
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2023-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-17', 'size': 117254, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-15T13:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants both in intervention and control were assessed for the asthma severity change using Global Strategy for Asthma Management and Prevention (GINA) Guideline', 'timeFrame': '3 and 6 months evaluation', 'description': 'The physician diagnoses asthma change at Taipei Hospital'}, {'measure': 'All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated', 'timeFrame': '3 and 6 months evaluation', 'description': 'The physician evaluate ACT change at Taipei Hospital for both group'}, {'measure': 'All participants were assessed for the change of Quality of life using MiniPAQLQ', 'timeFrame': '3 and 6 months evaluation', 'description': 'Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire'}, {'measure': 'All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire', 'timeFrame': '3 and 6 months evaluation', 'description': 'The physician evaluate PASS score change at Taipei Hospital for both group'}, {'measure': 'All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry', 'timeFrame': '3 and 6 months', 'description': 'The physician evaluate PEF change at Taipei Hospital for both group'}, {'measure': 'All participants were assessed for the change of asthma cost using direct and indirect costs from national website', 'timeFrame': '3 and 6 months', 'description': 'Researchers access the data from National Health Insurance database'}], 'secondaryOutcomes': [{'measure': 'All participants were assessed for their age in the baseline using data of birthday information', 'timeFrame': 'Baseline', 'description': 'Nurses and or researchers is responsible in filling the data from the patient admission in the Hospital'}, {'measure': 'All participants were assessed for the total serum IgE (kU/I) change from blood assessment', 'timeFrame': '3 and 6 months evaluation', 'description': 'The researcher and physician record and evaluate the data'}, {'measure': 'All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance', 'timeFrame': 'Baseline', 'description': 'The researcher and physician record and evaluate the data'}, {'measure': 'All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance', 'timeFrame': 'Baseline', 'description': 'The researcher and physician record and evaluate the data'}, {'measure': 'All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance', 'timeFrame': 'Baseline', 'description': 'The researcher and physician record and evaluate the data'}, {'measure': 'All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance', 'timeFrame': 'Baseline', 'description': 'The researcher and physician record and evaluate the data'}, {'measure': 'All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance', 'timeFrame': 'Baseline', 'description': 'The researcher and physician record and evaluate the data'}, {'measure': 'All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance', 'timeFrame': 'Baseline', 'description': 'The researcher and physician record and evaluate the data'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartphone selft-care system', 'asthma control', 'medical cost', 'emergency room visit', 'hospital admission'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate whether a smartphone app based on the Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of life, and decrease asthma-related costs in children. The main question it to answer whether this app can improve asthma control, increase the quality of life, and decrease asthma-related costs.\n\nParticipants in the intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits, while the control group received reminder calls. Researchers will compare with the control group to see if the intervention receives more asthma control improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 3 and 18 years;\n* who had access to the smartphone app;\n* with asthma treatment steps 2-4, requiring regular treatment with controller medication (for at least 6 months over the past year) according to the GINA guidelines;\n* who had at least two clinic or emergency department visits related to asthma in the previous year.\n\nExclusion Criteria:\n\n* Children who had comorbidities, or other major medical problems, and who did not have a smartphone or whose caregivers did not have a smartphone were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT05972668', 'briefTitle': 'Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Science and Technology, Taiwan'}, 'officialTitle': 'Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)', 'orgStudyIdInfo': {'id': 'TH-IRB-0016-0038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Intervention group needs to download the smartphone apps and follow research protocol', 'interventionNames': ['Device: Smartphone Apps']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Smartphone Apps', 'type': 'DEVICE', 'description': 'The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '242', 'city': 'Taipei City', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Hospital, Ministry of Health and Welfare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We don not plan to share individual participant data (IPD)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Taipei Hospital, Ministry of Health and Welfare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'I-Jen, Wang', 'investigatorAffiliation': 'Taipei Hospital, Ministry of Health and Welfare'}}}}