Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-03-09 @ 11:15 AM
Study NCT ID:
NCT00958932
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2009-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telecommunication Enhanced Asthma Management
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': 'benderb@njhealth.org', 'phone': '303-398-1697', 'title': 'Dr. Bruce Bender', 'organization': 'National Jewish Health'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A potential limitation to this study is that the most poorly adherent patients may have been excluded from the study since eligible patients were required to have made at least 1 Inhaled Corticosteroid fill in the 6 months prior to enrollment. An additional limitation may be non-applicability of the intervention to practices without an Electronic Health Record (EHR) or with an EHR that is different from the one used at Kaiser Permanente Colorado (KPCO).'}}, 'adverseEventsModule': {'timeFrame': '24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Speech Recognition (TEAM Intervention)', 'description': 'Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families.', 'otherNumAtRisk': 590, 'otherNumAffected': 0, 'seriousNumAtRisk': 590, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Speech Recognition (Usual Care)', 'description': 'Speech recognition: Automated, speech recognition telephone calls', 'otherNumAtRisk': 597, 'otherNumAffected': 0, 'seriousNumAtRisk': 597, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Speech Recognition (TEAM Intervention)', 'description': 'Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families.'}, {'id': 'OG001', 'title': 'Speech Recognition (Usual Care)', 'description': 'Speech recognition: Automated, speech recognition telephone calls'}], 'classes': [{'categories': [{'measurements': [{'value': '.445', 'groupId': 'OG000', 'lowerLimit': '.433', 'upperLimit': '.457'}, {'value': '.355', 'groupId': 'OG001', 'lowerLimit': '.344', 'upperLimit': '.366'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The primary outcome of this study, adherence, was expressed as a mean proportion of days covered (PDC) over 24 months. The PDC was calculated as the total number of ICS days supplied divided by the period for which the medication was prescribed. Calculation of the PDC was adjusted to account for the supply that would extend beyond the end of the study period. Comparisons were adjusted for baseline PDC, which was calculated as the ratio of number of days a patient had possession of medication divided by the number of days enrolled 1 year prior to randomization.', 'unitOfMeasure': 'Proportion of Days Covered', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The 899 participants remaining in the final analysis represent those who remained in the insurance network at 24 months post-randomization.'}, {'type': 'SECONDARY', 'title': 'Emergency Care Visits Per Person-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Speech Recognition (TEAM Intervention)', 'description': 'Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families.'}, {'id': 'OG001', 'title': 'Speech Recognition (Usual Care)', 'description': 'Speech recognition: Automated, speech recognition telephone calls'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '.05', 'upperLimit': '.07'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '.03', 'upperLimit': '.05'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Per one year of person-time', 'description': 'Asthma-related emergency care events were compared between the two study groups. In health insurance data, individual records often do not cover the entire period of study because people may leave the insurance network seeking new coverage, or after moving, etc. However, this partial data is still usable when pooled to calculate numbers of events of interest per person-year. For example, one person may only be in the study for six months, and they may log an emergency room. Another person may be in the study for 18 months and log no visits. Put together, the two participants log two person years of data (6 months + 18 months = 24 months = 2 person-years in the study) and between the two of them they log one emergency room visit, which results in an outcome of 0.5 emergency care visits, on average, per person-year of data available. This measure of central tendency is calculated for the two study groups to permit comparison.', 'unitOfMeasure': 'Number of visits per person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Speech Recognition (TEAM Intervention)', 'description': 'Speech recognition: The speech recognition intervention was designed to contact families overdue for a refill and encourage greater ICS adherence, personalizing the conversation with information in the EHR while using language designed to activate parents. Families randomized to the Intervention group received one of three speech recognition call types up to eleven times within each year depending on patterns of overdue refills. All routine clinical services, including telephone availability of asthma nurses and pharmacy staff, were available to both Intervention and Usual Care families.'}, {'id': 'FG001', 'title': 'Speech Recognition (Usual Care)', 'description': 'Speech recognition: Automated, speech recognition telephone calls'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '590'}, {'groupId': 'FG001', 'numSubjects': '597'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '452'}, {'groupId': 'FG001', 'numSubjects': '447'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '150'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'BG000'}, {'value': '597', 'groupId': 'BG001'}, {'value': '1187', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Speech Recognition (TEAM Intervention)', 'description': 'Speech recognition: The TEAM intervention is a program to increase communication with families, provide feedback to families about their refill adherence, assess asthma symptoms, deliver health communication messages, encourage parents to ask questions of asthma care managers, and facilitate refilling ICS prescription. Speech recognition calls will be tailored to specific situations including new or re-issued ICS prescriptions, failure to fill an initial prescription, failure to refill, or failure to refill following an ED visit, hospitalization, or oral steroid burst resulting from an asthma exacerbation.'}, {'id': 'BG001', 'title': 'Speech Recognition (Usual Care)', 'description': 'Speech recognition: Automated, speech recognition telephone calls'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '763', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '330', 'groupId': 'BG000'}, {'value': '339', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '431', 'groupId': 'BG000'}, {'value': '449', 'groupId': 'BG001'}, {'value': '880', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '590', 'groupId': 'BG000'}, {'value': '597', 'groupId': 'BG001'}, {'value': '1187', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2009-08-13', 'resultsFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-29', 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': '12 months', 'description': 'The primary outcome of this study, adherence, was expressed as a mean proportion of days covered (PDC) over 24 months. The PDC was calculated as the total number of ICS days supplied divided by the period for which the medication was prescribed. Calculation of the PDC was adjusted to account for the supply that would extend beyond the end of the study period. Comparisons were adjusted for baseline PDC, which was calculated as the ratio of number of days a patient had possession of medication divided by the number of days enrolled 1 year prior to randomization.'}], 'secondaryOutcomes': [{'measure': 'Emergency Care Visits Per Person-Year', 'timeFrame': 'Per one year of person-time', 'description': 'Asthma-related emergency care events were compared between the two study groups. In health insurance data, individual records often do not cover the entire period of study because people may leave the insurance network seeking new coverage, or after moving, etc. However, this partial data is still usable when pooled to calculate numbers of events of interest per person-year. For example, one person may only be in the study for six months, and they may log an emergency room. Another person may be in the study for 18 months and log no visits. Put together, the two participants log two person years of data (6 months + 18 months = 24 months = 2 person-years in the study) and between the two of them they log one emergency room visit, which results in an outcome of 0.5 emergency care visits, on average, per person-year of data available. This measure of central tendency is calculated for the two study groups to permit comparison.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '25664620', 'type': 'BACKGROUND', 'citation': 'Bender BG, Cvietusa PJ, Goodrich GK, Lowe R, Nuanes HA, Rand C, Shetterly S, Tacinas C, Vollmer WM, Wagner N, Wamboldt FS, Xu S, Magid DJ. Pragmatic trial of health care technologies to improve adherence to pediatric asthma treatment: a randomized clinical trial. JAMA Pediatr. 2015 Apr;169(4):317-23. doi: 10.1001/jamapediatrics.2014.3280.'}, {'pmid': '36689336', 'type': 'DERIVED', 'citation': 'Bender BG, Cvietusa PJ, Goodrich GK, King DK, Shoup JA. Adapting adaptive design methods to accelerate adoption of a digital asthma management intervention. Transl Behav Med. 2023 Apr 3;13(3):149-155. doi: 10.1093/tbm/ibac093.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this project is to conduct a randomized practical clinical trial within a large health maintenance organization to test a telephone intervention designed to improve adherence to daily asthma medications and thereby improve asthma outcomes. The investigators hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention group will be greater than in the usual care group.', 'detailedDescription': "Asthma affects more than 15 million people in the United States. Inhaled corticosteroids (ICS), the ranking treatment-of-choice, are safe and highly efficacious in controlled trials, but adherence to ICS medications in real-world settings is poor in all patient groups, especially low-income and minority patients who experience the most morbidity from asthma. Children and adults with asthma take less than half of their prescribed ICS medication. One study found that only 44% of ICS prescriptions for children with asthma were filled. Even the most effective medications have little value if not taken as prescribed. Decreasing use of ICS has been repeatedly linked to poor asthma control and increasing health care utilization.\n\nWe will conduct a randomized, practical clinical trial to test the impact of a communication enhancement program for parents of 3-12 year old children with asthma in the largest health maintenance organization (HMO) within Colorado. Research in this setting has the significant advantage of not only establishing the utility of a behavior-changing strategy, but at the same time demonstrating that the strategy can be applied in a large healthcare system and sustained over time. The proposed intervention will be referred to here as the Telecommunication Enhanced Adherence Management (TEAM) program. This proposal builds upon ongoing efforts within Kaiser Permanente of Colorado (KPCO), the participating HMO, to use automated telecommunication technology to prevent diabetes, reduce cardiac risk, reduce calorie consumption, and increase exercise adherence, with the introduction of an intervention to increase adherence with daily ICS therapy. Speech Recognition (SR), the telecommunication technology used in this trial, has not previously been employed to promote adherence in a population of children treated for asthma within a large HMO. TEAM creates a theory-based enhanced communication program using SR with support from asthma care manager nurses. The Asthma Care Manager program already exists within KPCO, but with SR the frequency and quality of communication with parents is expected to improve significantly, resulting in more ICS medication refills, better persistence in ICS use, and improved asthma outcomes. Through SR calls, parents will be reminded and motivated about the importance of continued daily use of ICS medications, asked about their child's recent asthma symptoms, and given the opportunity to receive a call back from an asthma care manager or to place a request for a medication refill."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3-12 year old children with asthma requiring daily corticosteroid\n\nExclusion Criteria:\n\n* sibling already in study\n* physician excludes from participation\n* non English Speaking'}, 'identificationModule': {'nctId': 'NCT00958932', 'acronym': 'TEAM', 'briefTitle': 'Telecommunication Enhanced Asthma Management', 'organization': {'class': 'OTHER', 'fullName': 'National Jewish Health'}, 'officialTitle': 'Telecommunication Enhanced Asthma Management', 'orgStudyIdInfo': {'id': '1R01HL084067-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL084067-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Speech recognition (TEAM intervention)', 'description': "Parents randomized to the intervention received speech recognition phone calls if their child's medication refill was overdue.", 'interventionNames': ['Behavioral: Speech recognition']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care'}], 'interventions': [{'name': 'Speech recognition', 'type': 'BEHAVIORAL', 'otherNames': ['usual care'], 'description': 'The TEAM intervention is a program to increase communication with families, provide feedback to families about their refill adherence, assess asthma symptoms, deliver health communication messages, encourage parents to ask questions of asthma care managers, and facilitate refilling ICS prescription. Speech recognition calls will be tailored to specific situations including new or re-issued ICS prescriptions, failure to fill an initial prescription, failure to refill, or failure to refill following an ED visit, hospitalization, or oral steroid burst resulting from an asthma exacerbation.', 'armGroupLabels': ['Speech recognition (TEAM intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Bruce G Bender, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Jewish Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Bruce Bender', 'investigatorAffiliation': 'National Jewish Health'}}}}