Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT01175369
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
2010-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
School-based Asthma Therapy: Stage 2 Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jill_halterman@urmc.rochester.edu', 'phone': '5852755798', 'title': 'Dr. Jill Halterman', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Usual asthma care', 'otherNumAtRisk': 265, 'otherNumAffected': 0, 'seriousNumAtRisk': 265, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'School-based Care', 'description': 'The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).', 'otherNumAtRisk': 265, 'otherNumAffected': 0, 'seriousNumAtRisk': 265, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Symptom Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual asthma care'}, {'id': 'OG001', 'title': 'School-based Care', 'description': 'The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)', 'description': 'The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cotinine Level', 'timeFrame': '2 month and approximately 9 month (end of school year) follow-up assessments', 'description': 'To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Cost Effectiveness of the Intervention', 'timeFrame': 'approximately 9 months (length of school year)', 'description': 'Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Additional Asthma Morbidity Outcomes', 'timeFrame': '1-9 months (Monthly Follow-up assessments)', 'description': 'We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Usual asthma care'}, {'id': 'FG001', 'title': 'School-based Care', 'description': 'The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '265'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '260'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual asthma care'}, {'id': 'BG001', 'title': 'School-based Care', 'description': 'The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '7.1', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-25', 'studyFirstSubmitDate': '2010-06-23', 'resultsFirstSubmitDate': '2013-01-14', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-14', 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Symptom Free Days', 'timeFrame': 'Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)', 'description': 'The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).'}], 'secondaryOutcomes': [{'measure': 'Cotinine Level', 'timeFrame': '2 month and approximately 9 month (end of school year) follow-up assessments', 'description': 'To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).'}, {'measure': 'Cost Effectiveness of the Intervention', 'timeFrame': 'approximately 9 months (length of school year)', 'description': 'Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.'}, {'measure': 'Additional Asthma Morbidity Outcomes', 'timeFrame': '1-9 months (Monthly Follow-up assessments)', 'description': 'We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '18446591', 'type': 'BACKGROUND', 'citation': 'Halterman JS, Borrelli B, Fisher S, Szilagyi P, Yoos L. Improving care for urban children with asthma: design and methods of the School-Based Asthma Therapy (SBAT) trial. J Asthma. 2008 May;45(4):279-86. doi: 10.1080/02770900701854908.'}, {'pmid': '19564303', 'type': 'BACKGROUND', 'citation': 'Fagnano M, van Wijngaarden E, Connolly HV, Carno MA, Forbes-Jones E, Halterman JS. Sleep-disordered breathing and behaviors of inner-city children with asthma. Pediatrics. 2009 Jul;124(1):218-25. doi: 10.1542/peds.2008-2525.'}, {'pmid': '19329093', 'type': 'BACKGROUND', 'citation': 'Conn KM, Hernandez T, Puthoor P, Fagnano M, Halterman JS. Screen time use among urban children with asthma. Acad Pediatr. 2009 Jan-Feb;9(1):60-3. doi: 10.1016/j.acap.2008.10.001.'}, {'pmid': '19047246', 'type': 'BACKGROUND', 'citation': 'Halterman JS, Borrelli B, Tremblay P, Conn KM, Fagnano M, Montes G, Hernandez T. Screening for environmental tobacco smoke exposure among inner-city children with asthma. Pediatrics. 2008 Dec;122(6):1277-83. doi: 10.1542/peds.2008-0104.'}, {'pmid': '19796913', 'type': 'BACKGROUND', 'citation': 'Halterman JS, Borrelli B, Conn KM, Tremblay P, Blaakman S. Motivation to quit smoking among parents of urban children with asthma. Patient Educ Couns. 2010 May;79(2):152-5. doi: 10.1016/j.pec.2009.09.004. Epub 2009 Sep 30.'}, {'pmid': '19233588', 'type': 'BACKGROUND', 'citation': 'Shone LP, Conn KM, Sanders L, Halterman JS. The role of parent health literacy among urban children with persistent asthma. Patient Educ Couns. 2009 Jun;75(3):368-75. doi: 10.1016/j.pec.2009.01.004. Epub 2009 Feb 23.'}, {'pmid': '18922501', 'type': 'BACKGROUND', 'citation': 'Fagnano M, Conn KM, Halterman JS. Environmental tobacco smoke and behaviors of inner-city children with asthma. Ambul Pediatr. 2008 Sep-Oct;8(5):288-93. doi: 10.1016/j.ambp.2008.04.002. Epub 2008 May 12.'}, {'pmid': '21816697', 'type': 'BACKGROUND', 'citation': 'Fagnano M, Bayer AL, Isensee CA, Hernandez T, Halterman JS. Nocturnal asthma symptoms and poor sleep quality among urban school children with asthma. Acad Pediatr. 2011 Nov-Dec;11(6):493-9. doi: 10.1016/j.acap.2011.05.006. Epub 2011 Aug 3.'}, {'pmid': '21911409', 'type': 'BACKGROUND', 'citation': 'Fagnano M, Halterman JS, Conn KM, Shone LP. Health literacy and sources of health information for caregivers of urban children with asthma. Clin Pediatr (Phila). 2012 Mar;51(3):267-73. doi: 10.1177/0009922811421413. Epub 2011 Sep 12.'}, {'pmid': '22717938', 'type': 'BACKGROUND', 'citation': 'Blaakman S, Tremblay PJ, Halterman JS, Fagnano M, Borrelli B. Implementation of a community-based secondhand smoke reduction intervention for caregivers of urban children with asthma: process evaluation, successes and challenges. Health Educ Res. 2013 Feb;28(1):141-52. doi: 10.1093/her/cys070. Epub 2012 Jun 20.'}, {'pmid': '23400614', 'type': 'BACKGROUND', 'citation': 'Noyes K, Bajorska A, Fisher S, Sauer J, Fagnano M, Halterman JS. Cost-effectiveness of the School-Based Asthma Therapy (SBAT) program. Pediatrics. 2013 Mar;131(3):e709-17. doi: 10.1542/peds.2012-1883. Epub 2013 Feb 11.'}, {'pmid': '24619226', 'type': 'BACKGROUND', 'citation': 'Koehler AD, Fagnano M, Montes G, Halterman JS. Elevated burden for caregivers of children with persistent asthma and a developmental disability. Matern Child Health J. 2014 Nov;18(9):2080-8. doi: 10.1007/s10995-014-1455-6.'}, {'pmid': '24528997', 'type': 'BACKGROUND', 'citation': 'Evans KA, Halterman JS, Hopke PK, Fagnano M, Rich DQ. Increased ultrafine particles and carbon monoxide concentrations are associated with asthma exacerbation among urban children. Environ Res. 2014 Feb;129:11-9. doi: 10.1016/j.envres.2013.12.001. Epub 2014 Jan 11.'}, {'pmid': '21383275', 'type': 'RESULT', 'citation': 'Halterman JS, Szilagyi PG, Fisher SG, Fagnano M, Tremblay P, Conn KM, Wang H, Borrelli B. Randomized controlled trial to improve care for urban children with asthma: results of the School-Based Asthma Therapy trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):262-8. doi: 10.1001/archpediatrics.2011.1.'}]}, 'descriptionModule': {'briefSummary': 'Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-diagnosed asthma\n* Mild persistent to severe persistent asthma\n* Ages 3-10 years\n* Attending school in the Rochester City School District preschools or elementary schools\n* Signed physician permission to enroll the child\n* Parent or caregiver must consent to the intervention\n\nExclusion Criteria:\n\n* Inability to speak and understand either English or Spanish\n* No access to a working phone for follow-up surveys\n* The family planning to leave the school district within fewer than 6 months\n* The child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures\n* children in foster care or other situations in which consent cannot be obtained from a guardian\n* Current participation in other local asthma interventions'}, 'identificationModule': {'nctId': 'NCT01175369', 'acronym': 'SBAT', 'briefTitle': 'School-based Asthma Therapy: Stage 2 Effectiveness Study', 'nctIdAliases': ['NCT00296998'], 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'School-Based Asthma Therapy: Stage 2 Effectiveness Study', 'orgStudyIdInfo': {'id': '12308'}, 'secondaryIdInfos': [{'id': '1R01HL079954-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL079954-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual asthma care'}, {'type': 'EXPERIMENTAL', 'label': 'School-based Care', 'description': 'The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).', 'interventionNames': ['Behavioral: School-based Care']}], 'interventions': [{'name': 'School-based Care', 'type': 'BEHAVIORAL', 'description': 'The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).', 'armGroupLabels': ['School-based Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Jill S. Halterman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Halcyon Hill Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Jill Halterman', 'investigatorAffiliation': 'University of Rochester'}}}}