Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
Study NCT ID:
NCT00218803
Status:
COMPLETED
Last Update Posted:
2008-09-05
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-03', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in emergency department visits', 'timeFrame': '10 months or 1 school year'}], 'secondaryOutcomes': [{'measure': 'Asthma Education', 'timeFrame': '10 months or 1 school year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '15704600', 'type': 'BACKGROUND', 'citation': 'Naumann PL, Huss K, Calabrese B, Smith T, Quartey R, Van de Castle B, Lewis C, Hill K, Walker J, Winkelstein M. A+ Asthma Rural Partnership coloring for health: an innovative rural asthma teaching strategy. Pediatr Nurs. 2004 Nov-Dec;30(6):490-4.'}]}, 'descriptionModule': {'briefSummary': 'To determine if teaching rural children with asthma and their parents about appropriate medication use, asthma triggers unique to a rural setting and increasing access to medical care will result in a decrease in emergency department visits.', 'detailedDescription': 'Many self-management asthma interventions have demonstrated increase in asthma knowledge, reduced emergency department visits, increased self-efficacy and quality of life. The type of self-management interventions, specifically individualized and interactive educational interventions, have been suggested to have the strongest effect on asthma morbidity. Few studies have tested asthma self-management educational interventions in increasing knowledge, self-efficacy and quality of life in rural pediatric populations. The goal of this study was to test the effectiveness of an asthma educational intervention in improving asthma knowledge in rural children and their parent/caregivers. We hypothesized that an interactive asthma educational intervention would increase parent/caregiver and child asthma knowledge resulting in decreased emergency room visits in rural families of children with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosed asthma, attend elementary school in rural county agreeing to participate\n\nExclusion Criteria: Participation in another asthma study or having other respiratory illness such as cystic fibrosis, BPD\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00218803', 'briefTitle': 'Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Nursing Research (NINR)'}, 'officialTitle': 'A+ Asthma Rural Partnership', 'orgStudyIdInfo': {'id': 'HBV 99-01-11-01'}, 'secondaryIdInfos': [{'id': '5R01NR005062-04', 'link': 'https://reporter.nih.gov/quickSearch/5R01NR005062-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Behavioral: Nurse asthma education intervention']}, {'type': 'OTHER', 'label': '2', 'interventionNames': ['Behavioral: Control Group']}], 'interventions': [{'name': 'Nurse asthma education intervention', 'type': 'BEHAVIORAL', 'description': 'Asthma Education', 'armGroupLabels': ['1']}, {'name': 'Control Group', 'type': 'BEHAVIORAL', 'description': 'Asthma Education', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Arlene M Butz, SCD,MSN,BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Arlene Butz, ScD, RN, MSN, Professor', 'oldOrganization': 'Johns Hopkins University School of Medicine, Department of Pediatrics'}}}}