Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT01881412
Status:
TERMINATED
Last Update Posted:
2020-05-18
First Post:
2013-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004630', 'term': 'Emergencies'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arisgarro1@gmail.com', 'phone': '401-480-8682', 'title': 'Dr. Aris Garro', 'organization': 'Rhode Island Hospital and Brown University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Inhaled Corticosteroid (Fluticasone)', 'description': "Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.\n\nfluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).\n\nStandard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)", 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Routine Asthma Care', 'description': "Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nStandard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)", 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Corticosteroid (Fluticasone)', 'description': "Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.\n\nfluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).\n\nStandard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}, {'id': 'OG001', 'title': 'Routine Asthma Care', 'description': "Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nStandard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'spread': '14', 'groupId': 'OG000'}, {'value': '84', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ED Visits for Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Corticosteroid (Fluticasone)', 'description': "Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.\n\nfluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).\n\nStandard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}, {'id': 'OG001', 'title': 'Routine Asthma Care', 'description': "Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nStandard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}], 'classes': [{'categories': [{'measurements': [{'value': '.37', 'spread': '1', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Emergency department visits for asthma over a 6 month period by parent report.', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Care Visits for Well Checks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Corticosteroid (Fluticasone)', 'description': "Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.\n\nfluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).\n\nStandard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}, {'id': 'OG001', 'title': 'Routine Asthma Care', 'description': "Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nStandard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Primary care visits well checks over a 6 month period by parent report.', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospitalizations for Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Corticosteroid (Fluticasone)', 'description': "Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.\n\nfluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).\n\nStandard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}, {'id': 'OG001', 'title': 'Routine Asthma Care', 'description': "Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nStandard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}], 'classes': [{'categories': [{'measurements': [{'value': '.06', 'spread': '.32', 'groupId': 'OG000'}, {'value': '.05', 'spread': '.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Hospitalizations for asthma over a 6 month period by parent report.', 'unitOfMeasure': 'Hospitalizations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unscheduled Primary Care Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Corticosteroid (Fluticasone)', 'description': "Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.\n\nfluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).\n\nStandard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}, {'id': 'OG001', 'title': 'Routine Asthma Care', 'description': "Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nStandard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}], 'classes': [{'categories': [{'measurements': [{'value': '.8', 'spread': '1', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Unscheduled primary care visits for asthma over a 6 month period by parent report.', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oral Steroid Courses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Corticosteroid (Fluticasone)', 'description': "Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.\n\nfluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).\n\nStandard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}, {'id': 'OG001', 'title': 'Routine Asthma Care', 'description': "Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nStandard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)"}], 'classes': [{'categories': [{'measurements': [{'value': '.54', 'spread': '.87', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Oral steroid courses over a 6 month period by parent report.', 'unitOfMeasure': 'Courses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inhaled Corticosteroid (ICS)', 'description': 'Child receives: 1) asthma discharge instructions, and 2) ICS prescription.\n\nAsthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.\n\nThe family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.'}, {'id': 'FG001', 'title': 'Routine Asthma Care', 'description': 'Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nAsthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inhaled Corticosteroid (ICS)', 'description': 'Child receives: 1) asthma discharge instructions, and 2) ICS prescription.\n\nAsthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.\n\nThe family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.'}, {'id': 'BG001', 'title': 'Routine Asthma Care', 'description': 'Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)\n\nAsthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Mixed race / other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-28', 'size': 651136, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-26T11:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'whyStopped': 'Funding complete', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2013-06-17', 'resultsFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-15', 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form', 'timeFrame': '6 months', 'description': "The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved."}], 'secondaryOutcomes': [{'measure': 'ED Visits for Asthma', 'timeFrame': '6 months', 'description': 'Emergency department visits for asthma over a 6 month period by parent report.'}, {'measure': 'Primary Care Visits for Well Checks', 'timeFrame': '6 months', 'description': 'Primary care visits well checks over a 6 month period by parent report.'}, {'measure': 'Hospitalizations for Asthma', 'timeFrame': '6 months', 'description': 'Hospitalizations for asthma over a 6 month period by parent report.'}, {'measure': 'Unscheduled Primary Care Visits', 'timeFrame': '6 months', 'description': 'Unscheduled primary care visits for asthma over a 6 month period by parent report.'}, {'measure': 'Oral Steroid Courses', 'timeFrame': '6 months', 'description': 'Oral steroid courses over a 6 month period by parent report.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'Children', 'Inhaled Corticosteroids', 'Emergency Department'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma.\n\nThis study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.', 'detailedDescription': "Specific aim 1 - An ED-based RCT to determine if ICS prescription in children identified using the PACCI as having uncontrolled asthma results in less asthma morbidity compared to routine asthma care. We hypothesize that children receiving ICS prescriptions will have fewer unscheduled health care use for asthma exacerbations (doctor's office visits, ED visits, or hospitalizations), and greater quality of life.\n\nSpecific aim 2 - Thematic analysis of interviews with parents who are adherent versus non-adherent with ICS prescription filling and use to determine the factors associated with adherence. We hypothesize that factors will include: 1) Parent beliefs about the chronic versus episodic nature of asthma, 2) Parent's knowledge of benefits and risks of ICS, and 3) Provision and use of an asthma action plan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 3 - 12 years of age\n* child has asthma diagnosed by a doctor based on parental/caregiver report\n* child is not already properly using an ICS or being discharged with an ICS\n\nExclusion Criteria:\n\n* The child has previously participated in this study\n* The child has major co-morbid disease of the heart or lungs (examples include cystic fibrosis, heart disease, muscular dystrophy and cerebral palsy with immobility. It does not include allergic rhinitis or a history of respiratory infections such as pneumonia or bronchiolitis.\n* The child's parents/caregivers do not speak English\n* The child is not going to be discharged from the emergency department (e.g. hospitalization)"}, 'identificationModule': {'nctId': 'NCT01881412', 'briefTitle': 'Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Optimizing Discharge After Emergency Department Visits for Children With Uncontrolled Asthma', 'orgStudyIdInfo': {'id': 'ACP-231928-N'}, 'secondaryIdInfos': [{'id': 'ACP-231928-N', 'type': 'OTHER_GRANT', 'domain': 'American Lung Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled corticosteroid (fluticasone)', 'description': 'Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.', 'interventionNames': ['Drug: fluticasone', 'Other: Standard Asthma Discharge Instructions']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Routine Asthma Care', 'description': 'Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)', 'interventionNames': ['Other: Standard Asthma Discharge Instructions']}], 'interventions': [{'name': 'fluticasone', 'type': 'DRUG', 'otherNames': ['inhaled corticosteroid'], 'description': 'During discharge, the study MD/nurse informs the family that the child has been randomized to the inhaled corticosteroid (ICS) group, and will be prescribed fluticasone to help control the asthma. The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of medication use, and distinction between controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.', 'armGroupLabels': ['Inhaled corticosteroid (fluticasone)']}, {'name': 'Standard Asthma Discharge Instructions', 'type': 'OTHER', 'description': "Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)", 'armGroupLabels': ['Inhaled corticosteroid (fluticasone)', 'Routine Asthma Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Rhode Island Hospital / Hasbro Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Aris C Garro, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University and Rhode Island Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data currently available on request', 'ipdSharing': 'YES', 'description': 'Availability on request', 'accessCriteria': 'Requests will be reviewed by the study investigators for appropriateness'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Lung Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}