Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-02-08 @ 3:29 PM
Study NCT ID:
NCT02093234
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2014-03-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changing the Healthcare Delivery Model
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}, {'id': 'D003150', 'term': 'Community Health Workers'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D000488', 'term': 'Allied Health Personnel'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RKatz@mfa.gwu.edu', 'phone': '202-741-2323', 'title': 'Richard Katz, MD', 'organization': 'GW Medical Faculty Associates'}, 'certainAgreement': {'otherDetails': 'The sponsor will conduct a peer review of the research report before it may be published.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was not collected.', 'description': 'Adverse event data was not collected due to the type of intervention used in this trial. The intervention was not a drug , biological product or device that is subject to FDA regulation.', 'eventGroups': [{'id': 'EG000', 'title': 'Mobile Health Care Application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.\n\nmobile health care application: mobile health application for cell phones to assist patients in managing their diabetes.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.\n\nCommunity Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CHWs and Mobile Health Care Application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application\n\nCHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Care Application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.\n\nmobile health care application: mobile health application for cell phones to assist patients in managing their diabetes.'}, {'id': 'OG001', 'title': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.\n\nCommunity Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways.'}, {'id': 'OG002', 'title': 'CHWs and Mobile Health Care Application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application\n\nCHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 1 year', 'description': 'The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.', 'unitOfMeasure': 'incomplete behaviors/goals', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample size estimates were based on the study hypotheses and the associated primary endpoint. Dropouts were analyzed using intention to treat methodology.'}, {'type': 'SECONDARY', 'title': 'Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Care Application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.\n\nmobile health care application: mobile health application for cell phones to assist patients in managing their diabetes.'}, {'id': 'OG001', 'title': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.\n\nCommunity Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways.'}, {'id': 'OG002', 'title': 'CHWs and Mobile Health Care Application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application\n\nCHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.89', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 year', 'description': 'Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24.\n\nLow distress \\< 12 : moderate / high distress \\> or = 12.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin A1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Care Application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.\n\nmobile health care application: mobile health application for cell phones to assist patients in managing their diabetes.'}, {'id': 'OG001', 'title': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.\n\nCommunity Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways.'}, {'id': 'OG002', 'title': 'CHWs and Mobile Health Care Application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application\n\nCHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 year', 'description': 'Change in HbA1c after 1 year from baseline', 'unitOfMeasure': 'Percentage of total hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Care Application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.\n\nmobile health care application: mobile health application for cell phones to assist patients in managing their diabetes.'}, {'id': 'OG001', 'title': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.\n\nCommunity Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways.'}, {'id': 'OG002', 'title': 'CHWs and Mobile Health Care Application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application\n\nCHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon signed rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 1 year', 'description': 'Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobile Health Care Application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.\n\nmobile health care application: mobile health application for cell phones to assist patients in managing their diabetes.'}, {'id': 'FG001', 'title': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.\n\nCommunity Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways.'}, {'id': 'FG002', 'title': 'CHWs and Mobile Health Care Application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application\n\nCHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': "Participants were recruited from 3 medical clinic sites in Washington DC. Each site had its' own Principal Investigator ,research coordinator and community health worker. Recruitment started April 2014 and ended July 2015. The study period for each participant was 1 year."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobile Health Care Application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.\n\nmobile health care application: mobile health application for cell phones to assist patients in managing their diabetes.'}, {'id': 'BG001', 'title': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.\n\nCommunity Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways.'}, {'id': 'BG002', 'title': 'CHWs and Mobile Health Care Application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application\n\nCHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '1.51', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '1.21', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '1.25', 'groupId': 'BG002'}, {'value': '52.9', 'spread': '0.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}]}, {'title': 'Other race', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2014-03-17', 'resultsFirstSubmitDate': '2016-12-29', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-21', 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1', 'timeFrame': 'baseline and 1 year', 'description': 'The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument', 'timeFrame': 'Baseline and 1 year', 'description': 'Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24.\n\nLow distress \\< 12 : moderate / high distress \\> or = 12.'}, {'measure': 'Change in Hemoglobin A1C', 'timeFrame': 'Baseline and 1 year', 'description': 'Change in HbA1c after 1 year from baseline'}, {'measure': 'Change in Medication Adherence', 'timeFrame': 'baseline and 1 year', 'description': 'Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['self care of diabetes type 2 patients', 'mobile health cell phone application impact on health', 'community health workers impact on health'], 'conditions': ['Diabetes Type 2']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.', 'detailedDescription': "This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for DM2 Medicaid patients with uncontrolled DM.\n\n* Group 1 will be assisted by the Voxiva Care4Life mobile health disease management program (C4L) provided on the patient's cell phone.\n* Group 2 will be assisted by CHWs who are members of the outpatient medical home health team.\n* Group 3 will be assisted by both the Voxiva Care4Life mHealth disease management system (C4L) and a CHW.\n\nHypotheses:\n\n1. A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.\n2. A patient interactive cell phone disease management system will activate Medicaid patients with type 2 diabetes (DM2) to improve the composite of 7 wellness behaviors and 6 clinical outcomes by 25% or greater compared to baseline\n\nExpected Outcomes:\n\nPrimary outcomes:\n\n1. Superior improvement over baseline of the composite of Wellness Behaviors and Clinical Outcomes in the CHW plus C4L group compared to the CHW alone and cell phone alone groups.\n2. Improvement by 25% or greater over baseline of the composite of Wellness Behaviors and Clinical Outcomes for patients using C4L alone.\n\nSecondary outcomes:\n\nImprovement in both clinical and behavior endpoints. Endpoints to be compared across the three treatment arms include:\n\n1. mean HbA1c,\n2. mean LDLc Cholesterol\n3. average BP if hypertensive\n4. Patient distress measured with Fisher Brief Diabetes Distress Screening Instrument\n\n4\\) Medication adherence measured with Morisky Medication Adherence Survey 5) Healthcare utilization: ER, acute clinic visits, hospitalizations\n\nAnticipated results and impact on healthcare:\n\nMobile health has great potential to enhance DM2 patient health behaviors and clinical outcomes both alone and, even better, with assistance of a CHW. mHealth systems can be provided to a wide range of urban and rural DM2 patients resulting in an affordable, a more efficient patient-driven/centered health delivery system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 to 75 years old\n* Medicaid insurance coverage, Medicare insurance coverage or Affordable Health Care Act insurance coverage\n* Fluent in English or Spanish and able to read a text message\n* Diagnosed with diabetes mellitus type 2 and A1C is \\> 8%\n\nAcceptable values will be either :\n\n* A1c obtained within one month prior to baseline (as long as there were no diabetes changes made during that month) or\n* A new A1c measured at the baseline screening visit.\n* Meets \\< 10 of the wellness behaviors and clinical goals if diagnosed with hypertension Meets \\< 9 of the wellness behaviors and clinical goals if not diagnosed with hypertension\n\nExclusion Criteria:\n\n* Stage 5 chronic kidney disease or end stage renal disease on dialysis\n* Terminal illness (expected survival of less than one year)\n* Severe dementia or uncontrolled mental illness\n* Gestational diabetes mellitus\n* Use of an insulin pump\n* Inability to use a cellular phone\n* Unable to use software application on cellular phone\n* Pregnant or planning to get pregnant'}, 'identificationModule': {'nctId': 'NCT02093234', 'acronym': 'C4H', 'briefTitle': 'Changing the Healthcare Delivery Model', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy', 'orgStudyIdInfo': {'id': 'PCORI- IH-1304-6797'}, 'secondaryIdInfos': [{'id': 'IH-1304-6797', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mobile health care application', 'description': 'Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.', 'interventionNames': ['Behavioral: mobile health care application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Community Health Worker (CHW)', 'description': 'CHWs assist study patients in managing there health care in various ways.', 'interventionNames': ['Behavioral: Community Health Worker (CHW)']}, {'type': 'EXPERIMENTAL', 'label': 'CHWs and mobile health care application', 'description': 'Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application', 'interventionNames': ['Behavioral: CHWs and mobile health care application']}], 'interventions': [{'name': 'mobile health care application', 'type': 'BEHAVIORAL', 'otherNames': ['Care 4 Life'], 'description': 'mobile health application for cell phones to assist patients in managing their diabetes.', 'armGroupLabels': ['Mobile health care application']}, {'name': 'CHWs and mobile health care application', 'type': 'BEHAVIORAL', 'otherNames': ['Care 4 Life and patient navigators'], 'description': 'CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.', 'armGroupLabels': ['CHWs and mobile health care application']}, {'name': 'Community Health Worker (CHW)', 'type': 'BEHAVIORAL', 'otherNames': ['Patient navigators'], 'description': 'CHWs assist patients in managing their diabetes in various ways.', 'armGroupLabels': ['Community Health Worker (CHW)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medical Faculty Assoc Inc, GWUniv', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Richard Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Faculty Assoc. Inc, GWUniv'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified participant data for all primary and secondary outcomes measures will be made available with 6 months of study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}