Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT00136305
Status:
TERMINATED
Last Update Posted:
2021-08-26
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Asthma Action Plans for Pediatric Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D055118', 'term': 'Medication Adherence'}], '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': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'PI moved to a different institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores on the Asthma Action Plan Knowledge Interview', 'timeFrame': '1 month', 'description': 'Measures recall of asthma treatment plan'}], 'secondaryOutcomes': [{'measure': 'Adherence to Controller Medication', 'timeFrame': '1 month', 'description': 'Mean daily adherence to medication measured via electronic monitoring'}, {'measure': 'Rescue Medication Use', 'timeFrame': '1 month', 'description': 'Number of puffs of inhaled rescue medication'}, {'measure': 'Family satisfaction survey scores', 'timeFrame': '1 month', 'description': 'Family ratings of satisfaction with asthma action plan'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric asthma', 'asthma action plans', 'patient education', 'medication adherence'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate and compare the relative effectiveness of two asthma action plans (pictorial versus written) in terms of asthma action plan knowledge, medication use, and family satisfaction with asthma education.', 'detailedDescription': "Asthma medical regimens are complex for families, requiring changes in the types and amounts of medication based on the frequency and intensity of symptoms. Written asthma action plans (AAP's) are commonly used to provide a set of instructions to help parents and children implement these complicated regimens. However, written AAP's require substantial literacy levels, so for younger children, low-literacy families, or non-English speaking families, a pictorial version of the AAP may be more understandable and useful. The study aims to validate a newly developed, fully pictorial AAP in terms of its relative impact on parent- and child-reported knowledge of the action plan, medication use, and parent- and child-reported satisfaction, when compared to a standard-care written AAP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who are new patients\n* Receive a diagnosis of persistent asthma\n* Are in need of an asthma action plan\n\nExclusion Criteria:\n\n* Diagnosed with intermittent asthma\n* An established patient who already has an asthma action plan\n* Not English or Spanish speaking'}, 'identificationModule': {'nctId': 'NCT00136305', 'briefTitle': 'Comparing Asthma Action Plans for Pediatric Asthma', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Relative Effectiveness of Pictorial and Written Asthma Action Plans for Pediatric Asthma', 'orgStudyIdInfo': {'id': '04 08-102E'}, 'secondaryIdInfos': [{'id': 'KBR 01.4182'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pictorial Asthma Action Plan', 'interventionNames': ['Behavioral: Pictorial asthma action plan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Written Asthma Action Plan', 'interventionNames': ['Behavioral: Written asthma action plan']}], 'interventions': [{'name': 'Pictorial asthma action plan', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pictorial Asthma Action Plan']}, {'name': 'Written asthma action plan', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Written Asthma Action Plan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "The Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Christina D Adams, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Children's Mercy Hospitals and Clinics"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'collaborators': [{'name': 'Katherine B. Anderson Associates Endowment Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}