Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-05 @ 1:05 AM
Study NCT ID:
NCT02435394
Status:
WITHDRAWN
Last Update Posted:
2016-04-21
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'After IRB review, this study is no longer considered a clinical trial', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NHLBI recommended controller meds used', 'timeFrame': '3-12 months', 'description': 'match between severity rating and NHLBI recommended med mgt'}], 'secondaryOutcomes': [{'measure': 'Emergency department visits', 'timeFrame': '3-12 months', 'description': 'Self reported interval ED visits'}, {'measure': 'Asthma trigger mitigation', 'timeFrame': '3-12 months', 'description': 'self-reported efforts to reduce asthma triggers'}, {'measure': 'Hospitalizations for asthma', 'timeFrame': '3-12 months', 'description': 'Self reported hospitalizations'}, {'measure': 'Steroid bursts', 'timeFrame': '3-12 months', 'description': 'Self reported use of steroid bursts for asthma exacerbations'}, {'measure': 'Influenza vaccine receipt', 'timeFrame': '3-12 months', 'description': 'self reported receipt of flu vaccine for this season'}, {'measure': 'asthma symptom control', 'timeFrame': '3-12 months', 'description': 'severity/control ratings'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care. This project is to develop and test the effects of using a module for guideline based care in the Child Health and Development Interactive System (CHADIS) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and Asthma Action Plans in individual Care Portals.', 'detailedDescription': "We will complete the formative work collecting professional opinion to create and pilot the initial CHADIS Asthma Intervention module (CHADIS-AI), an innovative decision support system. CHADIS-AI content will be assembled and vetted by asthma experts and primary care providers (PCPs). Parent and teen focus groups will vet the content and language of the adherence materials and Care Portal. A system will also be established for points for patient participation, to give clinicians Maintenance of Certification (MOC) credit, and ongoing run chart reports of their patients' asthma status for continual Quality Improvement (QI) feedback. The resulting system will be pilot tested and refined by clinician feedback. Practices will be randomly assigned to intervention vs control. Control practices will use CHADIS for asthma care without the A-I module. Intervention practices will be further randomized to have remote coach support for patients or not. Outcomes will be examined of asthma severity/control, match of severity with guideline based medication management, numbers of Emergency Department (ED) visits, hospitalizations and oral steroid use. Effect of remote coaching will also be assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma diagnosis\n\nExclusion Criteria:\n\n* Not English or Spanish speaking'}, 'identificationModule': {'nctId': 'NCT02435394', 'acronym': 'Asthma', 'briefTitle': 'Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Total Child Health, Inc.'}, 'officialTitle': 'Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement', 'orgStudyIdInfo': {'id': '1R44HL117482', 'link': 'https://reporter.nih.gov/quickSearch/1R44HL117482', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Coach plus Asthma Module', 'description': 'The intervention is for practices to have remote coach support for patients with asthma in addition to doctors using CHADIS-Asthma module. Practices will start sequentially for a time series analysis.', 'interventionNames': ['Behavioral: Remote Coach plus Asthma Module']}, {'type': 'EXPERIMENTAL', 'label': 'Asthma Module- No Coach', 'description': 'The intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence.', 'interventionNames': ['Behavioral: Asthma Module- No Coach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHADIS- no Asthma module', 'description': 'Practices using CHADIS but no Asthma module as a control condition.', 'interventionNames': ['Behavioral: CHADIS- no Asthma Module']}], 'interventions': [{'name': 'Remote Coach plus Asthma Module', 'type': 'BEHAVIORAL', 'otherNames': ['Remote Coach'], 'description': 'The intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care.', 'armGroupLabels': ['Remote Coach plus Asthma Module']}, {'name': 'Asthma Module- No Coach', 'type': 'BEHAVIORAL', 'description': 'The intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach.', 'armGroupLabels': ['Asthma Module- No Coach']}, {'name': 'CHADIS- no Asthma Module', 'type': 'BEHAVIORAL', 'description': 'The practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care.', 'armGroupLabels': ['CHADIS- no Asthma module']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21210', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Total Child Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Barbara J Howard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Total Child Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Total Child Health, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}