Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-02-04 @ 12:56 AM
Study NCT ID:
NCT03032159
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2016-04-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities
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': 'Tumaini.Coker@seattlechildrens.org', 'phone': '206-884-0559', 'title': 'Tumaini R. Coker, MD, MBA', 'organization': "Seattle Children's"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the 12-month study period.', 'description': 'Adverse events reported for the enrolled parent or their child.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': "Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.", 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Text2Breathe Study Group', 'description': 'The "study" group spends about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Emergency Department Visits for Asthma Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': "Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'id': 'OG001', 'title': 'Text2Breathe Study Group', 'description': 'The "study" group spends about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Number of emergency department visits for asthma care', 'unitOfMeasure': 'ED visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asthma Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': "Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'id': 'OG001', 'title': 'Text2Breathe Study Group', 'description': 'The "study" group spends about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group'}], 'classes': [{'categories': [{'measurements': [{'value': '3.36', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Asthma morbidity measured as the number of days (or nights) of impairment.', 'unitOfMeasure': 'max symptom days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Scheduled Asthma Care Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': "Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'id': 'OG001', 'title': 'Text2Breathe Study Group', 'description': 'The "study" group spends about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group'}], 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Number of visits with PCP for preventative asthma care in past 12 months', 'unitOfMeasure': 'number of visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Asthma Self-Management Questionnaire Standardized Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': "Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'id': 'OG001', 'title': 'Text2Breathe Study Group', 'description': 'The "study" group spends about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group'}], 'classes': [{'categories': [{'measurements': [{'value': '59.68', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '58.67', 'spread': '19.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The Asthma Self-Management Questionnaire, recommended by experts convened for the Asthma Outcomes workshop, includes 16 multiple-choice questions regarding knowledge of preventive strategies and controller medication use. Standardized scores (0-100) are generated, with higher scores indicating more knowledge of self-management. Cronbach\'s alpha was 0.71. Wording of questions has been revised (e.g., "you" = "your child") to be appropriate for parents of children with asthma.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Parental Expectations for Child's Asthma Treatment Average Score", 'timeFrame': '12 months', 'description': 'In accordance with other research of pediatric asthma interventions, to assess parents\' beliefs about possible asthma quality of life for their child we will administer an 8-item measure of parental expectations for asthma treatment. Parents respond to statements about their expectations (e.g., "I believe that my child can be symptom free most of the time.") using a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Total scores are calculated by averaging across responses, and higher scores reflect more optimistic asthma outcome expectations (Cronbach\'s alpha = 0.70).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Parental Self-efficacy for Communicating With Healthcare Providers Self-competence Scale Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': "Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'id': 'OG001', 'title': 'Text2Breathe Study Group', 'description': 'The "study" group spends about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group'}], 'classes': [{'categories': [{'measurements': [{'value': '78.72', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '78.63', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The Medical Competence Communication Scale (MCCS) measures patient\'s perceptions of their own communication during their most recent medical visits. The patient version of the measure is used to assess information giving, seeking and verifying, as well as socio-emotional communication. The MCCS, patient version, consists of 23 items rated on a 5-point Likert scale (1= unimportant to 5= important) with a higher score indicating greater perception of communication competence (range 16-80). Cronbach\'s alpha ranges from 0.76-0.92 on the various subscales. Only the 16 self-competence items will be administered in this study. Wording of questions will be modified to state "my child\'s medical problem" rather than "my medical problem."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Parental Asthma Management Self-efficacy Scale Summary Score', 'timeFrame': '12 months', 'description': "The Parent Asthma Management Self-Efficacy Scale (PAMSES) is a valid and reliable instrument designed to measure parent self-efficacy in preventing and managing children's asthma attacks. The PAMSES consists of 13 items rated on a 5-point Likert scale (1=not at all sure to 5=completely sure) with a total possible score range of 13 to 65; higher scores indicate greater self-efficacy. Cronbach's alpha in a sample of primarily White mothers was 0.87.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': "Parents randomized to the control group child will receive their usual asthma care from their provider. Additionally, participants (parents) in the control group will receive reminder texts to schedule with their child's primary care provider (PCP) and to get an annual flu shot. Participants (parents) will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'id': 'FG001', 'title': 'Text2Breathe Study Group', 'description': 'Parents in the "study" group spend about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally, parents in this group were enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Paret participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Parents will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Eligible parents randomized.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'comment': 'Completed 12-month Follow-Up Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '34'}]}]}], 'recruitmentDetails': "Participants (parents) were recruited from two children's hospitals in Seattle and Tacoma, Washington from 2015-2019.", 'preAssignmentDetails': 'Of the 661 potential parent participants screened for eligibility, 221 were eligible and randomized. Participants are unique parent/child dyads. The parents were enrolled, and each parent had a child that they provided data on. Those that were screened but excluded either did not meet inclusion criteria or declined to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': "Parents randomized to the control group child will receive their usual asthma care from their provider. Additionally, parents in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Parents will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'id': 'BG001', 'title': 'Text2Breathe Study Group', 'description': 'Parents in the "study" group spend about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally, parents in this group enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Parents randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Parents will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.\n\nText2Breathe Study Group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Child Age (years). Parents reported on age of child. We did not collect data on parent age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participant (Parent) reported sex', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Parent race and ethnicity', 'categories': [{'title': 'Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Non-Latino Black', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Multiracial', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Non-Latino White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Parents enrolled into the control (usual care) group and intervention (Text2Breathe study group).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-15', 'size': 626347, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-23T22:54', 'hasProtocol': True}, {'date': '2014-07-10', 'size': 153524, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-23T22:54', 'hasProtocol': False}, {'date': '2017-06-06', 'size': 260940, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-23T22:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-09', 'studyFirstSubmitDate': '2016-04-20', 'resultsFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-16', 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Scheduled Asthma Care Visits', 'timeFrame': '12 months', 'description': 'Number of visits with PCP for preventative asthma care in past 12 months'}, {'measure': 'Asthma Self-Management Questionnaire Standardized Score', 'timeFrame': '12 months', 'description': 'The Asthma Self-Management Questionnaire, recommended by experts convened for the Asthma Outcomes workshop, includes 16 multiple-choice questions regarding knowledge of preventive strategies and controller medication use. Standardized scores (0-100) are generated, with higher scores indicating more knowledge of self-management. Cronbach\'s alpha was 0.71. Wording of questions has been revised (e.g., "you" = "your child") to be appropriate for parents of children with asthma.'}, {'measure': "Parental Expectations for Child's Asthma Treatment Average Score", 'timeFrame': '12 months', 'description': 'In accordance with other research of pediatric asthma interventions, to assess parents\' beliefs about possible asthma quality of life for their child we will administer an 8-item measure of parental expectations for asthma treatment. Parents respond to statements about their expectations (e.g., "I believe that my child can be symptom free most of the time.") using a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Total scores are calculated by averaging across responses, and higher scores reflect more optimistic asthma outcome expectations (Cronbach\'s alpha = 0.70).'}, {'measure': 'Parental Self-efficacy for Communicating With Healthcare Providers Self-competence Scale Summary Score', 'timeFrame': '12 months', 'description': 'The Medical Competence Communication Scale (MCCS) measures patient\'s perceptions of their own communication during their most recent medical visits. The patient version of the measure is used to assess information giving, seeking and verifying, as well as socio-emotional communication. The MCCS, patient version, consists of 23 items rated on a 5-point Likert scale (1= unimportant to 5= important) with a higher score indicating greater perception of communication competence (range 16-80). Cronbach\'s alpha ranges from 0.76-0.92 on the various subscales. Only the 16 self-competence items will be administered in this study. Wording of questions will be modified to state "my child\'s medical problem" rather than "my medical problem."'}, {'measure': 'Parental Asthma Management Self-efficacy Scale Summary Score', 'timeFrame': '12 months', 'description': "The Parent Asthma Management Self-Efficacy Scale (PAMSES) is a valid and reliable instrument designed to measure parent self-efficacy in preventing and managing children's asthma attacks. The PAMSES consists of 13 items rated on a 5-point Likert scale (1=not at all sure to 5=completely sure) with a total possible score range of 13 to 65; higher scores indicate greater self-efficacy. Cronbach's alpha in a sample of primarily White mothers was 0.87."}], 'primaryOutcomes': [{'measure': 'Emergency Department Visits for Asthma Care', 'timeFrame': '12 months', 'description': 'Number of emergency department visits for asthma care'}], 'secondaryOutcomes': [{'measure': 'Asthma Morbidity', 'timeFrame': '12 months', 'description': 'Asthma morbidity measured as the number of days (or nights) of impairment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between parents and their children\'s\' primary care providers about asthma. The overarching goal of this study is to reduce disparities among a population with high rates of pediatric asthma morbidity. The investigators are testing the efficacy of a short message service (SMS)-enhanced health communication (HC) intervention ("Text2Breathe") designed to equip urban, low-income parents with tools for communicating effectively with their children\'s primary care provider (PCP).', 'detailedDescription': "Potentially eligible participants are approached and screened in person during an admission of their child to the emergency department for asthma care. Those participants randomized to the intervention will receive additional education on effective communication with their child's primary care provider (PCP). These participants will also receive educational text messages for three months after their initial visit. Text messages will include education on effectively communicating with their child's provider and general asthma information. Both the control group and intervention group will receive text message reminders to schedule regular follow up visits with their PCP and get an annual flu shot. Both groups will be contacted for follow up phone interviews at 3, 6, 12, 18 and 24 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unlimited text messaging\n\nIs the parent of child who is:\n\n* Receiving asthma related care in the emergency department\n* 2-12 years old inclusive\n* Medicaid insured (no Private insurance)\n* Physician diagnosed asthma for at least 12 months\n\nExclusion Criteria:\n\nIs the parent of child who:\n\n* Has seen a pulmonary or allergy sub-specialist more than once in the last 6 months\n* Has seen a sub-specialist (not pulmonary or allergy) more than once in the last 12 months\n* Has been hospitalized for more than 30 days\n* Is currently enrolled in another asthma program or study'}, 'identificationModule': {'nctId': 'NCT03032159', 'acronym': 'T2B', 'briefTitle': 'Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities', 'orgStudyIdInfo': {'id': '15488'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment."}, {'type': 'EXPERIMENTAL', 'label': 'Text2Breathe Study Group', 'description': 'The "study" group spends about 10-20 minutes learning about ways to have better communication with their child\'s primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child\'s PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.', 'interventionNames': ['Behavioral: Text2Breathe Study Group']}], 'interventions': [{'name': 'Text2Breathe Study Group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Text2Breathe Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': "Mary Bridge Children's Hospital at Multi Care Health System", 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Tumaini Coker, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital and Research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "MultiCare Mary Bridge Children's Hospital & Health Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tumaini Coker', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}