Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-01 @ 6:36 PM
Study NCT ID:
NCT04474795
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinic to Community Connections - Broader Distribution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'herrickc@wustl.edu', 'phone': '3147470278', 'title': 'Cynthia Herrick, MD, MPHS', 'organization': 'Washington University In St. Louis School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Individuals were not assigned to an intervention that was anticipated to result in adverse events. Individuals had the opportunity to contact the study team with questions or concerns at any time over the course of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Staff - Educational Training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare\n\nStaff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff - Educational Training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare\n\nStaff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.'}], 'classes': [{'title': 'Pre-training Score (Baseline)', 'categories': [{'measurements': [{'value': '6.60', 'groupId': 'OG000', 'lowerLimit': '4.93', 'upperLimit': '7.66'}]}]}, {'title': 'Post-training Score (Module Completion)', 'categories': [{'measurements': [{'value': '9.33', 'groupId': 'OG000', 'lowerLimit': '9.00', 'upperLimit': '9.87'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Compared pre and post training scores', 'statisticalMethod': 'Wilcoxon paired signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': "Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Population who completed pre and post training assessments and accessed all 4 training modules'}, {'type': 'SECONDARY', 'title': 'Staff - Diabetes Knowledge Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff - Educational Training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare\n\nStaff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.'}], 'classes': [{'title': 'Pre-training score (Baseline)', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '48.9', 'upperLimit': '65.2'}]}]}, {'title': 'Post-training score (Module completion)', 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '65.2', 'upperLimit': '87.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of scores pre and post training in individuals who completed training modules', 'statisticalMethod': 'Wilcoxon paired signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': 'Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who completed pre and post-test assessments and accessed all 4 training modules'}, {'type': 'SECONDARY', 'title': 'Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff - Educational Training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare\n\nStaff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.'}], 'classes': [{'title': 'Pre-training score (Patient Autonomy)', 'categories': [{'measurements': [{'value': '4.44', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '4.59'}]}]}, {'title': 'Post-training score (Patient Autonomy)', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000', 'lowerLimit': '3.91', 'upperLimit': '4.63'}]}]}, {'title': 'Pre-training score (value of tight control)', 'categories': [{'measurements': [{'value': '4.07', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '4.54'}]}]}, {'title': 'Post-training score (value of tight control)', 'categories': [{'measurements': [{'value': '4.43', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '4.86'}]}]}, {'title': 'Pre-training score (need for special training)', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '4.60', 'upperLimit': '5.00'}]}]}, {'title': 'Post-training score (need for special training)', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '4.65', 'upperLimit': '5.00'}]}]}], 'analyses': [{'pValue': '0.606', 'groupIds': ['OG000'], 'groupDescription': 'Patient autonomy', 'statisticalMethod': 'Wilcoxon paired signed rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Value of tight control', 'statisticalMethod': 'Wilcoxon paired signed rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.475', 'groupIds': ['OG000'], 'groupDescription': 'Need for Special Training', 'statisticalMethod': 'Wilcoxon paired signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': 'Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre and post training scores in individuals who completed training modules'}, {'type': 'SECONDARY', 'title': 'Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff - Educational Training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare\n\nStaff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.'}], 'classes': [{'title': 'Pre-training score', 'categories': [{'measurements': [{'value': '4.81', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '5.00'}]}]}, {'title': 'Post-training score', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '5.00'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon paired signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': "Change in staff's intention to recommend postpartum diabetes screening measured by a survey developed for this study (mean score; min 1, max 5) higher score= increased intention to perform action", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Staff-General Self Efficacy Scale (Schwarzer)', 'timeFrame': 'Baseline', 'description': 'General Self Efficacy measure (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Sum Score (min: 10, max: 40); higher score=more confidence', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale', 'timeFrame': 'Baseline', 'description': 'Measure of teaching motivation (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Mean score (min: 0, max 4) higher score=more intrinsic motivation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Staff - Educational Training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare\n\nStaff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'Completed Pre-test', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'Accessed Training Module 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'Accessed Training Module 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'Accessed Training Module 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Accessed Training Module 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Staff - Educational Training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare\n\nStaff -Educational training: Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'groupId': 'BG000', 'lowerLimit': '30.0', 'upperLimit': '49.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American, non-Hispanic', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Latinx or Hispanic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Native American, Asian, another race', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'White, non-Hispanic', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education/Training', 'classes': [{'title': 'Nurses (RN/LPN/CHN), CDCES, or RD', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'CHW or MA', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Specialty', 'classes': [{'title': 'Internal Medicine/Family Medicine', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Ob-Gyn/Maternal -Child Health', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'GDM knowledge score', 'classes': [{'title': 'Overall Score', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'BG000', 'lowerLimit': '48.4', 'upperLimit': '65.2'}]}]}, {'title': 'Module 1 Score', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'BG000', 'lowerLimit': '60.0', 'upperLimit': '80.0'}]}]}, {'title': 'Module 2 Score', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'BG000', 'lowerLimit': '50.0', 'upperLimit': '66.7'}]}]}, {'title': 'Module 3 Score', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'BG000', 'lowerLimit': '42.9', 'upperLimit': '57.1'}]}]}, {'title': 'Module 4 Score', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'BG000', 'lowerLimit': '40.0', 'upperLimit': '60.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Self-Efficacy to Provide Diabetes Education Scale', 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'groupId': 'BG000', 'lowerLimit': '5.90', 'upperLimit': '8.27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Diabetes Attitudes Scale', 'classes': [{'title': 'Patient autonomy', 'categories': [{'measurements': [{'value': '4.25', 'groupId': 'BG000', 'lowerLimit': '3.97', 'upperLimit': '4.50'}]}]}, {'title': 'Value of tight control', 'categories': [{'measurements': [{'value': '4.14', 'groupId': 'BG000', 'lowerLimit': '3.71', 'upperLimit': '4.57'}]}]}, {'title': 'Need for special training', 'categories': [{'measurements': [{'value': '4.80', 'groupId': 'BG000', 'lowerLimit': '4.60', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Intention to Recommend Diabetes Prevention Measures', 'classes': [{'categories': [{'measurements': [{'value': '4.63', 'groupId': 'BG000', 'lowerLimit': '4.13', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Population of individuals who completed at least 50% of one of the measures on the baseline survey'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-28', 'size': 351784, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-30T15:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2020-05-18', 'resultsFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-30', 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Staff-General Self Efficacy Scale (Schwarzer)', 'timeFrame': 'Baseline', 'description': 'General Self Efficacy measure (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Sum Score (min: 10, max: 40); higher score=more confidence'}, {'measure': 'Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale', 'timeFrame': 'Baseline', 'description': 'Measure of teaching motivation (for use in validation of the Self-Efficacy for Providing Diabetes Education Scale) Mean score (min: 0, max 4) higher score=more intrinsic motivation'}], 'primaryOutcomes': [{'measure': 'Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': "Pre-Post change in staff participants' perceived self-efficacy to provide diabetes education (Mean score min:1 max 10) high score=more confident"}], 'secondaryOutcomes': [{'measure': 'Staff - Diabetes Knowledge Test', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': 'Change in diabetes knowledge measured by multiple choice test (% correct out of 21 items) high score =better knowledge'}, {'measure': 'Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': 'Change in diabetes attitudes measured by 3 subscales of DAS-3 (Mean score min 1, max 5) high score=better attitudes'}, {'measure': 'Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)', 'timeFrame': 'Baseline and upon module completion (approximately 3 months)', 'description': "Change in staff's intention to recommend postpartum diabetes screening measured by a survey developed for this study (mean score; min 1, max 5) higher score= increased intention to perform action"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes in pregnancy', 'type 2 diabetes prevention', 'diabetes', 'Care coordination', 'care delivery', 'care fragmentation', 'community health worker', 'community partnership', 'community health aides', 'federally qualified health center', 'underserved population', 'patient education'], 'conditions': ['Gestational Diabetes', 'Gestational Diabetes Mellitus in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '39251972', 'type': 'DERIVED', 'citation': 'Krutilova P, Williams R, Morey R, Field C, Byrth V, Tepe M, McQueen A, Herrick C. Gestational diabetes knowledge improves with interactive online training modules. BMC Med Educ. 2024 Sep 9;24(1):977. doi: 10.1186/s12909-024-05969-z.'}, {'pmid': '37398401', 'type': 'DERIVED', 'citation': 'Krutilova P, Williams R, Morey R, Field C, Byrth V, Tepe M, McQueen A, Herrick C. Gestational diabetes knowledge improves with interactive online training modules: a pre-post analysis. Res Sq [Preprint]. 2023 Jun 2:rs.3.rs-2860961. doi: 10.21203/rs.3.rs-2860961/v1.'}]}, 'descriptionModule': {'briefSummary': 'This study addresses education needs in gestational diabetes care and followup at the staff and patient levels.\n\nIn the initial phase, nurses and community health workers will complete specific training modules on gestational diabetes developed for this study. The effectiveness of the education modules will be evaluated through pre/post surveys of participants assessing diabetes knowledge, attitudes, and self-efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinic staff: nurses (RN, LPN, BSN), community health workers, and others involved in maternal child health care\n\nExclusion Criteria:\n\nClinic staff: individuals not involved in maternal child health care or who do not consent to participate in study'}, 'identificationModule': {'nctId': 'NCT04474795', 'briefTitle': 'Clinic to Community Connections - Broader Distribution', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Clinic to Community Connections: Enhancing Prenatal to Postpartum Care Transitions to Prevent Type 2 Diabetes in Low Income Women With Gestational Diabetes', 'orgStudyIdInfo': {'id': '202007060'}, 'secondaryIdInfos': [{'id': '1K23HD096204-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23HD096204-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Staff - Educational training', 'description': 'Nurses, community health workers, and others involved in maternal healthcare', 'interventionNames': ['Behavioral: Staff -Educational training']}], 'interventions': [{'name': 'Staff -Educational training', 'type': 'BEHAVIORAL', 'description': 'Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.', 'armGroupLabels': ['Staff - Educational training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63107', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Affinia Healthcare', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Cynthia J Herrick, MD, MPHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Longer Life Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}