Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-20 @ 8:27 PM
Study NCT ID:
NCT03036267
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility of the BREATHE Asthma Intervention Trial
Sponsor:
Organization:
Raw JSON
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for descriptive purposes only', 'description': 'Full Title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only those with asthma completed the survey'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Focus Groups', 'description': 'Six focus group were held with adults with asthma and their (adult) loved ones'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Focus Groups', 'description': 'Six focus group were held with adults with asthma and their (adult) loved ones'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'spread': '11.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-21', 'size': 261261, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-30T18:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2017-01-26', 'resultsFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-03', 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Control Questionnaire', 'timeFrame': 'Baseline - for descriptive purposes only', 'description': 'Full Title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['health disparity', 'motivational interviewing', 'African American adults', 'Federally Qualified Health Centers', 'adherence', 'health beliefs', 'self-management', 'asthma control'], 'conditions': ['Asthma Chronic', 'Health Behavior']}, 'referencesModule': {'references': [{'pmid': '31414396', 'type': 'BACKGROUND', 'citation': 'George M, Arcia A, Chung A, Coleman D, Bruzzese JM. African Americans Want a Focus on Shared Decision-Making in Asthma Adherence Interventions. Patient. 2020 Feb;13(1):71-81. doi: 10.1007/s40271-019-00382-x.'}, {'pmid': '30479020', 'type': 'DERIVED', 'citation': 'George M, Pantalon MV, Sommers MLS, Glanz K, Jia H, Chung A, Norful AA, Poghosyan L, Coleman D, Bruzzese JM. Shared decision-making in the BREATHE asthma intervention trial: A research protocol. J Adv Nurs. 2019 Apr;75(4):876-887. doi: 10.1111/jan.13916. Epub 2019 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A brief shared decision-making intervention for use by primary care providers in Federally Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve asthma control in this high-risk patient group.', 'detailedDescription': "Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in poor and minority populations. Non-adherence to ICS is associated with erroneous personal health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this, no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared decision-making interventions have not been tested in underserved Black adults, despite this model's success in pediatric populations and in White, privately insured patients with asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients achieve asthma control but are overlooked in asthma intervention research. Process evaluations are often lacking during intervention development. We will address these treatment and methodological gaps.\n\nObjectives: This pilot study will (1) develop a brief shared decision-making intervention delivered by primary care providers (PCPs) to improve asthma control in Black adults receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and (3) assess preliminary evidence of intervention effects on asthma control, ICS adherence, forced expiratory volume in one second (FEV1) - an objective lung function measure - and asthma quality of life (QOL) over a 3-month follow-up period.\n\nHypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months, relative to controls, patients whose PCPs are trained in the intervention will have significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma QOL (secondary outcomes).\n\nMethods: Using community-based participatory research and including a Patient Advocate, we will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention development is guided by patient and family/support persons of asthma patients input, as well as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from 2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs will be randomized within FQHC to intervention and control; patients will be followed for 3 months. Process evaluation interviews with patients and PCPs will obtain feedback regarding intervention procedures.\n\nSignificance: This study has high public health significance because it (1) targets a highly vulnerable population for poor asthma control - Black poor adults with erroneous asthma care beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and negative ICS beliefs, and which has the potential to amplify intervention effects and increase the likelihood of sustainability; and (3) includes a process evaluation, bridging the gap between science and practice, and aiding in the design of a full-scale randomized controlled trial (RCT)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The intervention trial will be informed by focus groups\n\nFocus Group Inclusion Criteria:\n\n\\- Adult patients with persistent asthma or loved ones of adult patients with persistent asthma (prescribed ICS regardless of whether they are using ICS or not) receiving care at the participating FQHCs\n\nFocus Group Exclusion Criteria:\n\n\\- Patients with persistent asthma or loved ones of patients with persistent asthma under they age of 18 OR NOT prescribed ICS or NOT receiving care at the participating FQHCs\n\nIntervention Inclusion Criteria:\n\nPatients must be:\n\n1. Adults (18 years of age or older)\n2. PCP-diagnosed persistent asthma\n3. Currently prescribed ICS\n4. Receiving asthma care at participating FQHCs\n5. Who screen positive for uncontrolled asthma\n6. Have erroneous personal health and/or negative ICS beliefs\n\nIntervention Exclusion Criteria:\n\n1. Participation in focus groups during the development phase\n2. Non-English speaking\n3. Serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses'}, 'identificationModule': {'nctId': 'NCT03036267', 'briefTitle': 'Feasibility of the BREATHE Asthma Intervention Trial', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial', 'orgStudyIdInfo': {'id': 'AAAR0605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BREATHE', 'description': '7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach', 'interventionNames': ['Behavioral: BREATHE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control Condition', 'description': '7-minute diet and exercise discussion', 'interventionNames': ['Other: Attention Control Condition']}], 'interventions': [{'name': 'BREATHE', 'type': 'BEHAVIORAL', 'otherNames': ['Shared decision-making using motivational interviewing'], 'description': 'Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.', 'armGroupLabels': ['BREATHE']}, {'name': 'Attention Control Condition', 'type': 'OTHER', 'description': 'PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.', 'armGroupLabels': ['Attention Control Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Spectrum Health Services', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Greater Philadelphia Health Action', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Maureen George, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Nursing', 'investigatorFullName': 'Maureen George', 'investigatorAffiliation': 'Columbia University'}}}}