Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-02-01 @ 11:59 PM
Study NCT ID:
NCT02253433
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2014-09-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Houston HIITBAC for African Americans
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': 'hamilton@bcm.edu', 'phone': '713-798-1052', 'title': 'Dr. Winifred J. Hamilton', 'organization': 'Environmental Health, Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations included (1) lack of a control group (the enhanced clinic visit = a robust intervention), (2) mobility of the participants, (3) disproportionate lost to follow-up, (4) missing data, (5) out-of-window encounters, and (6) Hurricane Harvey.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Clinic Care', 'description': 'This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Clinic Care + Home Intervention', 'description': 'This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).\n\nEnhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 0, 'seriousNumAtRisk': 134, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Asthma Control Test (ACT) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Clinic Care', 'description': 'This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.'}, {'id': 'OG001', 'title': 'Enhanced Clinic Care + Home Intervention', 'description': 'This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).\n\nEnhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.60', 'ciLowerLimit': '-.87', 'ciUpperLimit': '2.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (enrollment) and exit (approximately 12 mo after enrollment)', 'description': 'Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At baseline, one individual in each group chose not to answer all five ACT questions; therefore a total ACT score could not be calculated for those two individuals (missing data are addressed in the analyses). At exit, among those who completed the study, one person in the enhanced in-clinic group chose not to answer all five ACT questions.'}, {'type': 'PRIMARY', 'title': 'Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Clinic Care', 'description': 'This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.'}, {'id': 'OG001', 'title': 'Enhanced Clinic Care + Home Intervention', 'description': 'This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).\n\nEnhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.25', 'ciLowerLimit': '-.18', 'ciUpperLimit': '.68', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (enrollment) and exit (approximately 12 mo after enrollment)', 'description': "Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the enhanced in-clinic care group, one person withdrew immediately after consent and two individuals chose not to fill out all of the answers, such that a score could not be computer. At exit, 3 control and 1 intervention were missing (1) or incomplete (3).'}, {'type': 'SECONDARY', 'title': 'Change in Emergency Department (ED) Visits for Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Clinic Care', 'description': 'This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.'}, {'id': 'OG001', 'title': 'Enhanced Clinic Care + Intervention', 'description': 'This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).\n\nEnhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.86', 'ciLowerLimit': '.47', 'ciUpperLimit': '1.57', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (enrollment) and exit (approximately 12 mo after enrollment)', 'description': 'Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked "During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?". We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient from the enhanced in-clinic only group withdrew immediately after consenting.114 "control" and 79 "intervention" completed the study. Respondent number less than enrollment and/or exit numbers reflects individuals who chose not to respond to the question.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Clinic Care', 'description': 'This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.'}, {'id': 'FG001', 'title': 'Enhanced Clinic Care + Home Intervention', 'description': 'This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).\n\nEnhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Unable to Contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No Longer Interested', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Out of Study Area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Uncomfortable with home visitors', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Unstable Housing/Homeless', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Too Busy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Medical or Other Concerns', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Clinic Care', 'description': 'This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.'}, {'id': 'BG001', 'title': 'Enhanced Clinic Care + Home Intervention', 'description': 'This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).\n\nEnhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.4', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Asthma Control Test (ACT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '12.5', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant consented and withdrew before any baseline characteristics (aside from age, gender and race) were collected. A second participant chose not to answer all five questions.'}, {'title': 'Juniper Mini Asthma Quality of Life Questionnaire', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'In the enhanced clinical care ("control") group, one person withdrew immediately after consent, and two individuals chose not to answer one of the 15 questions. In the home-visit ("intervention") group, three individuals chose not to answer one question. Interpolation (inserted worst answer) was used in some of the analyses.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.0', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured at clinic. BMI = weight (kilograms) divided by height (meters) squared. It is an estimate of body fat in adults. 30 and higher = obese.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One person withdrew immediately after consent.'}, {'title': 'Total Immunoglobulin E (Total IgE)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '550.5', 'spread': '1479.8', 'groupId': 'BG000'}, {'value': '643.2', 'spread': '1217.6', 'groupId': 'BG001'}, {'value': '597.6', 'spread': '1351.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total IgE is a measure of the immunoglobulin E antibody in the blood, and an estimate of allergic status. The laboratory lowest level of detection was 18 kU/L. Guidelines vary and must be assessed in conjunction with clinical presentation and allergen-specific testing, but for this population we consider a Total IgE \\> 100 kU/L to be of clinical relevance.', 'unitOfMeasure': 'kU/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant withdrew immediately after consent, permission for a blood draw was not given by two patients, and blood could not be obtained or was insufficient for analysis in four patients.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-21', 'size': 318963, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-31T19:30', 'hasProtocol': True}, {'date': '2016-12-20', 'size': 550478, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-11-07T19:55', 'hasProtocol': False}, {'date': '2018-09-09', 'size': 151473, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-07T20:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2014-09-29', 'resultsFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-09', 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Asthma Control Test (ACT) Score', 'timeFrame': 'At baseline (enrollment) and exit (approximately 12 mo after enrollment)', 'description': 'Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.'}, {'measure': 'Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)', 'timeFrame': 'At baseline (enrollment) and exit (approximately 12 mo after enrollment)', 'description': "Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life)."}], 'secondaryOutcomes': [{'measure': 'Change in Emergency Department (ED) Visits for Asthma', 'timeFrame': 'At baseline (enrollment) and exit (approximately 12 mo after enrollment)', 'description': 'Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked "During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?". We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['asthma', 'environmental triggers', 'home-based intervention', 'asthma home visits'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '32151753', 'type': 'DERIVED', 'citation': 'Bruhl RJ, Perkison WB, Hanania NA, McNeill LH, Oluyomi AO, Fiesinger EB, Minard CG, Solomon A, Hamilton WJ; Patient/Stakeholder Advisory Board and other members of the HIITBAC Research Team:; Butler B, Caldwell J, Crosby E, Davis C, Galvan H, Harris R, Lacour-Chestnut F, Martin C, Pannell S, Phipps K, Richardson G, Solomon A, White W, Boles J, Rangel A, Virk R, Brock M, Guffey D, Ramamurthy U, Persse D, Maffei S, Chan W, Reyes B. Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial. Contemp Clin Trials. 2020 Apr;91:105977. doi: 10.1016/j.cct.2020.105977. Epub 2020 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve the health of African-American adults who have poorly controlled asthma. The study compares a home-based exposure reduction and asthma control intervention to enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing. The interventional group receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).', 'detailedDescription': 'The study hypothesis is that the addition of a holistic, home-based environmental exposure reduction and asthma control intervention to enhanced in-clinic care will result in statistically significant improvements in key measures of health and quality of life among Houston-area African-American adults with poorly controlled asthma.\n\nThis is a pragmatic randomized controlled clinical trial that compares the effectiveness of a customized, holistic, patient-centered, home-based environmental intervention for improving asthma control (the "intervention") with enhanced clinic-based care. Both arms receive identical in-clinic care, including collected self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing. The intent of the study is to assess-real-life effectiveness of a home-based intervention in African-American adults with poorly controlled asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* African-American\n* 18 years of age or older\n* Diagnosis of poorly controlled asthma\\*\n* Fixed address within Harris County, Texas, with no intention of moving within the following 12 months\n* Working telephone number\n* Verbally fluent in English\n\n * Poorly controlled asthma was defined as (1) diagnosed by a physician as having asthma in the past and currently has asthma, and (2) fulfills one or more of the following criteria: (a) one or more emergency department (ED), urgent care visits or hospitalizations for asthma in the preceding year; (b) meets the definition of "very poorly controlled" asthma as defined by the National Asthma Education and Prevention Program, Third Expert Panel on the Diagnosis and Management of Asthma (definition includes daily asthma symptoms, nighttime awakenings two or more times per week, extremely limited normal activity, and/or daily use of a short-acting beta agonist for symptom control); and/or (c) an Asthma Control Test score of 19 or lower.\n\nEXCLUSION CRITERIA:\n\n* Severe co-morbid conditions-such as a poorly controlled psychiatric illness or a condition requiring intense medical treatment that could reasonably be expected to (1) confound the effects of this study\'s intervention, (2) make it unlikely that a participant could follow the treatment plan, or (3) pose a safety issue for the home-visit team.\n* A concurrent pulmonary study that could reasonably be expected to confound the effects of the intervention.\n* Living in a group living facility, such as a nursing home.'}, 'identificationModule': {'nctId': 'NCT02253433', 'acronym': 'HIIT-BAC', 'briefTitle': 'The Houston HIITBAC for African Americans', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'The Houston Home-Based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans', 'orgStudyIdInfo': {'id': 'PCORI AS-1308-05887'}, 'secondaryIdInfos': [{'id': 'H-34115', 'type': 'OTHER', 'domain': 'Baylor College of Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Clinic Care', 'description': 'This arm receives enhanced in-clinic care only.', 'interventionNames': ['Other: Enhanced Clinic Care']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Clinic Care + Home Intervention', 'description': 'This arm receives the enhanced in-clinic care intervention, as well as a home-based intervention.', 'interventionNames': ['Other: Enhanced Clinic Care', 'Other: Enhanced Clinic Care + Home Intervention']}], 'interventions': [{'name': 'Enhanced Clinic Care', 'type': 'OTHER', 'description': 'The intervention includes a standard clinical appointment including spirometry, as well as collection of self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.', 'armGroupLabels': ['Enhanced Clinic Care', 'Enhanced Clinic Care + Home Intervention']}, {'name': 'Enhanced Clinic Care + Home Intervention', 'type': 'OTHER', 'description': 'The home-based component includes environmental exposure assessment (observed and measured) and a multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).', 'armGroupLabels': ['Enhanced Clinic Care + Home Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Harris Health Smith Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Winifred J Hamilton, PhD, SM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bcm.edu/environmentalhealth', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The study protocol and ICF have been shared and are available on request. At the aggregate level, the initial findings of the pragmatic clinical trial were made available to our Patient/Stakeholder Advisory Panel at the February 12, 2018 meeting of the panel; at a regional Town Hall on asthma on May 1, 2018; and to participants who requested results by mail in November 2018. The Draft Final Research Report was submitted to PCORI in September 2018 and is undergoing external peer review. Two manuscripts--on methods and initial results--are being finalized for journal submission. The SAP and analytic code are currently undergoing refinement as we begin our secondary analyses and should be available in 2019.', 'ipdSharing': 'YES', 'description': 'Participants receive their individual laboratory, exposure and other data, as well as their customized asthma control plan, to help them manage their asthma. This information is delivered to participants at clinic and/or at home visits as appropriate. Laboratory results may be mailed as well. Aggregate data were made available to participants at a regional Town Hall 5/1/2018 and by mail as requested at exit by participants. Aggregate and/or de-identified data were and are being made available to the Patient / Stakeholder Advisory Board and to researchers through presentations, websites, publications and data sharing arrangements. No identifiable IDP will be made available to other researchers except through consent of the participant and IRB approval.', 'accessCriteria': 'Access criteria are based on protection of individual participant data as described in the protocol and ICF. Aggregate and de-identified data will be made available electronically, in the Rice University Kinder Urban Data Base Platform, and in presentations and manuscripts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harris County Hospital District', 'class': 'OTHER_GOV'}, {'name': 'Houston Department of Health and Human Services', 'class': 'UNKNOWN'}, {'name': 'Texas A&M University', 'class': 'OTHER'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'UTHealth School of Public Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Environmental Health Service', 'investigatorFullName': 'Winifred J. Hamilton, PhD', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}