Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-19 @ 9:21 PM
Study NCT ID:
NCT02779556
Status:
COMPLETED
Last Update Posted:
2021-12-15
First Post:
2016-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'KBHADDEN@uams.edu', 'phone': '501-993-3178', 'title': 'Kristie Hadden, PhD/Associate Professor', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months\n\nADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook', 'otherNumAtRisk': 394, 'deathsNumAtRisk': 394, 'otherNumAffected': 0, 'seriousNumAtRisk': 394, 'deathsNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months\n\nACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide', 'otherNumAtRisk': 362, 'deathsNumAtRisk': 362, 'otherNumAffected': 0, 'seriousNumAtRisk': 362, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin A1C (HbA1C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months\n\nADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months\n\nACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '8.6'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '8.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Six months', 'description': "HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.", 'unitOfMeasure': 'Percentage of glycated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '119 individuals were excluded from analysis, because they did not have a 6 month HbA1c value within the designated window.'}, {'type': 'PRIMARY', 'title': 'Hemoglobin A1C (HbA1C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months\n\nADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months\n\nACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '8.7'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Twelve months', 'description': "HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.", 'unitOfMeasure': 'Percentage of glycated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '240 individuals were excluded from analysis, because they did not have a 12 month HbA1c value within the designated window.'}, {'type': 'SECONDARY', 'title': 'Diabetes Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months\n\nADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months\n\nACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '9.4'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '9.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Three months', 'description': 'A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '116 participants were excluded, missed 3 month visit.'}, {'type': 'SECONDARY', 'title': 'Diabetes Knowledge (0-13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months\n\nADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months\n\nACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '9.6'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '9.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Six months', 'description': 'A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '142 participants were excluded, missed 6 month visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months\n\nADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months\n\nACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}, {'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}, {'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Partial baseline interview completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '3 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}, {'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Missed 3 month clinic visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}, {'title': '6 Month', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Those who were not lost to follow-up but missed the visit from the previous period were allowed to continue in the study and complete future interviews (314+19=333 Enhanced Usual Care).', 'groupId': 'FG000', 'numSubjects': '353'}, {'comment': 'Those who were not lost to follow-up but missed the visit from the previous period were allowed to continue in the study and complete future interviews (326+27=353 Intervention).', 'groupId': 'FG001', 'numSubjects': '333'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}, {'groupId': 'FG001', 'numSubjects': '294'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '39'}]}]}, {'title': '6 Month HbA1c', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All enrolled participants were eligible for the analysis of clinical values regardless of completion of 3 and 6 month interviews.', 'groupId': 'FG000', 'numSubjects': '394'}, {'comment': 'All enrolled participants were eligible for the analysis of clinical values regardless of completion of 3 and 6 month interviews.', 'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}, {'groupId': 'FG001', 'numSubjects': '312'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'No value collected during window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '50'}]}]}, {'title': '12 Month HbA1c', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All enrolled participants were eligible for the analysis of clinical values regardless of completion of 3 and 6 month interviews.', 'groupId': 'FG000', 'numSubjects': '394'}, {'comment': 'All enrolled participants were eligible for the analysis of clinical values regardless of completion of 3 and 6 month interviews.', 'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '260'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '102'}]}], 'dropWithdraws': [{'type': 'No value collected during window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '102'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '756', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months\n\nADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months\n\nACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '353', 'groupId': 'BG001'}, {'value': '741', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Less than High School', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'High School Graduate', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}, {'title': 'Some College', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}, {'title': 'College Graduate', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Refused to answer question', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health Literacy (NVS)', 'classes': [{'categories': [{'title': 'Limited', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': 'Adequate', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Health Literacy (NVS) Newest Vital Sign', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-04', 'size': 867941, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-02T17:37', 'hasProtocol': True}, {'date': '2018-10-16', 'size': 242532, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-02T17:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 756}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2016-05-04', 'resultsFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-14', 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1C (HbA1C)', 'timeFrame': 'Six months', 'description': "HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome."}, {'measure': 'Hemoglobin A1C (HbA1C)', 'timeFrame': 'Twelve months', 'description': "HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome."}], 'secondaryOutcomes': [{'measure': 'Diabetes Knowledge', 'timeFrame': 'Three months', 'description': 'A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.'}, {'measure': 'Diabetes Knowledge (0-13)', 'timeFrame': 'Six months', 'description': 'A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Literacy', 'Diabetes'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.\n\nThe primary aims are to:\n\n1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;\n2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.\n\n The secondary aims are to:\n3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;\n4. determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and\n5. assess the costs associated with implementing the intervention from a health system perspective.', 'detailedDescription': "The investigators will test the effectiveness and fidelity of embedding the American College of Physicians (ACP) diabetes health literacy intervention among patient-centered medical homes throughout rural Arkansas. Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that have been designed for individuals with lower literacy skills, that can be readily implemented and sustained among rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on the team developed an evidence-based, patient-centered, low literacy ACP intervention promoting diabetes self-care that includes:\n\n1. a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change;\n2. a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans');\n3. a training module for physicians, nurses, and medical assistants that prepares providers to assume educator/counselor roles with the Diabetes Guide as a teaching tool;\n4. electronic tracking and monitoring tools for primary care practices.\n\nWhile the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, it has not yet been comprehensively tested in practices, and its optimal implementation is not known. The investigators now have a unique opportunity to learn from prior evaluation, modify and disseminate an ACP health literacy intervention among patients with type 2 diabetes cared at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices are embedding care coordination services that can be leveraged to improve chronic disease management. All are supervised by a new University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy. The investigators' revised intervention will blend outsourced and clinic-based approaches and redeploy health coaches for counseling self-management mostly via phone, but also at the point-of-care. This is a feasible way to reach rural, vulnerable patients. The investigators will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.\n\nThe primary aims are to:\n\n1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;\n2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.\n\n The secondary aims are to:\n3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;\n4. determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and\n5. assess the costs associated with implementing the intervention from a health system perspective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years of age or older\n* English speaking\n* active patient at regional family medical center study site\n* confirmed diagnosis of type 2 diabetes as documented in the electronic health record\n* recent Hemoglobin A1c reading of \\>7.5% and less than or equal to 10%\n\nExclusion Criteria:\n\n* uncorrectable visual impairments\n* hearing impairments\n* cognitive impairments'}, 'identificationModule': {'nctId': 'NCT02779556', 'briefTitle': 'Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients', 'orgStudyIdInfo': {'id': '204290'}, 'secondaryIdInfos': [{'id': '1R01DK107572-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK107572-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Enhanced Usual Care', 'description': 'ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months', 'interventionNames': ['Other: ADA Living Well with Diabetes Workbook']}, {'type': 'OTHER', 'label': 'Intervention', 'description': 'ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months', 'interventionNames': ['Other: ACP Living with Diabetes Guide']}], 'interventions': [{'name': 'ACP Living with Diabetes Guide', 'type': 'OTHER', 'description': 'American Colleges of Physicians (ACP) Living Well with Diabetes Guide', 'armGroupLabels': ['Intervention']}, {'name': 'ADA Living Well with Diabetes Workbook', 'type': 'OTHER', 'description': 'American Diabetes Association (ADA) Living Well with Diabetes Workbook', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UAMS Family Medical Center Northwest', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72901', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UAMS Family Medical Center Fort Smith', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UAMS Family Medical Center Jonesboro', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '71753', 'city': 'Magnolia', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UAMS Family Medical Center Magnolia', 'geoPoint': {'lat': 33.26707, 'lon': -93.23933}}, {'zip': '71603', 'city': 'Pine Bluff', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UAMS Family Medical Center Pine Bluff', 'geoPoint': {'lat': 34.22843, 'lon': -92.0032}}, {'zip': '71854', 'city': 'Texarkana', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UAMS Family Medical Center Texarkana', 'geoPoint': {'lat': 33.44179, 'lon': -94.03769}}], 'overallOfficials': [{'name': 'Kristie Hadden, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'This will be available 6 months after publication of main study results.', 'ipdSharing': 'YES', 'description': 'The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to NIH investigators upon request. Consulting with program officer to ensure data sharing compliance.', 'accessCriteria': 'Require an NIH investigator with an IRB approved protocol, to conduct secondary data analysis of the available dataset.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'Louisiana State University Health Sciences Center Shreveport', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}