Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-25 @ 4:22 PM
Study NCT ID:
NCT00232557
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2005-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Telecommunications System in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.sparrow@va.gov', 'phone': '857-364-6407', 'title': 'Dr. David Sparrow', 'organization': 'VA Boston Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens', 'otherNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'A TLC system for providing general health education', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Unscheduled Asthma-related Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC-Asthma', 'description': 'A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens'}, {'id': 'OG001', 'title': 'TLC-health Education', 'description': 'A TLC system for providing general health education'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants With Oral Corticosteroid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC-Asthma', 'description': 'A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens'}, {'id': 'OG001', 'title': 'TLC-health Education', 'description': 'A TLC system for providing general health education'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of participants found to have any use of oral corticosteroids related to asthma during one year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TLC-Asthma', 'description': 'A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens'}, {'id': 'FG001', 'title': 'TLC-health Education', 'description': 'A TLC system for providing general health education'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TLC-Asthma', 'description': 'A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens'}, {'id': 'BG001', 'title': 'TLC-health Education', 'description': 'A TLC system for providing general health education'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subject with baseline examination'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2005-09-30', 'resultsFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2005-09-30', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-16', 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Unscheduled Asthma-related Visits', 'timeFrame': '1 year', 'description': 'Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.'}], 'secondaryOutcomes': [{'measure': 'Participants With Oral Corticosteroid Use', 'timeFrame': '1 year', 'description': 'Number of participants found to have any use of oral corticosteroids related to asthma during one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Disease Management', 'Telecommunications', 'Health Services', 'Quality of Life', 'Patient Compliance'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This project is investigating whether application of a telecommunications system to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak-flow-based action plans.', 'detailedDescription': 'Background/Rationale:\n\nAsthma is one of the most common chronic diseases of adults, affecting 6% of the U.S. adult population and accounting for substantial morbidity and mortality. Despite the availability of effective therapy for asthma, morbidity and mortality have increased over the last several decades. Asthma specialty care, case management, and patient education are means for improving the quality of asthma care and patient outcomes, but cost and inconvenience limit the degree to which these are used in asthma care nationally. The principal aim of this study is to evaluate the impact of an inexpensive telephone-based home education and disease monitoring system on asthma medication adherence and clinical outcomes in adult patients with asthma.\n\nObjective(s):\n\nWe hypothesize that application of TLC to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak flow-based action plans. This, in turn, will improve asthma control, thus reducing acute health care utilization and improving quality of life (QOL).\n\nMethods:\n\nA randomized controlled trial will be conducted with adult asthma patients identified from the VA Boston Healthcare System comprised of the Boston, West Roxbury, and Brockton VA Medical Centers and their associated satellite clinics. Patients will be randomized to either the TLC-Asthma group or an attention placebo control group. Outcome measurements will include medication adherence, QOL, utilization of urgent care services, oral corticosteroid use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of asthma\n* Receiving treatment with one or more daily controller (i.e., preventive) medications\n* Age = 18 years\n* Less than 30 pack years of cigarette smoking\n* FEVi greater than 50% of predicted\n* FEVi bronchodilator response of at least 12%\n* Ability to use a telephone without assistance\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT00232557', 'briefTitle': 'Telecommunications System in Asthma', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Effectiveness of a Telecommunications System in Asthma Management', 'orgStudyIdInfo': {'id': 'IIR 01-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TLC-Asthma', 'description': 'Telephone-based home education and asthma monitoring', 'interventionNames': ['Device: TLC-Asthma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TLC-health education', 'description': 'Telephone-based home education', 'interventionNames': ['Device: TLC-health education']}], 'interventions': [{'name': 'TLC-Asthma', 'type': 'DEVICE', 'description': 'Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens', 'armGroupLabels': ['TLC-Asthma']}, {'name': 'TLC-health education', 'type': 'DEVICE', 'description': 'A telephone-linked communication system (TLC) to provide general health education.', 'armGroupLabels': ['TLC-health education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David William Sparrow, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}