Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT00388050
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2006-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Medication Choice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2006-10-12', 'studyFirstSubmitQcDate': '2006-10-12', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding', 'timeFrame': 'Directly proceeding the clinical encounter'}, {'measure': 'Decisional Conflict', 'timeFrame': 'Directly proceeding the clinical visit'}, {'measure': 'Treatment Action, adherence', 'timeFrame': 'Directly proceeding the clinical encounter, 6 months after the clinical encounter'}], 'secondaryOutcomes': [{'measure': 'Trust', 'timeFrame': 'Directly proceeding the clinical visit'}, {'measure': 'Acceptability', 'timeFrame': 'Directly proceeding the clinical encounter'}]}, 'conditionsModule': {'keywords': ['Decision aid, diabetes, primary care'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '25179289', 'type': 'DERIVED', 'citation': 'Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.'}, {'pmid': '22640439', 'type': 'DERIVED', 'citation': 'LeBlanc A, Ruud KL, Branda ME, Tiedje K, Boehmer KR, Pencille LJ, Van Houten H, Matthews M, Shah ND, May CR, Yawn BP, Montori VM. The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. BMC Health Serv Res. 2012 May 28;12:130. doi: 10.1186/1472-6963-12-130.'}, {'pmid': '19786674', 'type': 'DERIVED', 'citation': 'Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required\n* Use 1 or 2 oral hypoglycemic agents; not using insulin therapy\n* Are not pregnant\n* Have stable but inadequate glycemic control: both A1C at the time of eligibility and previous A1c within 6 months between 7-9.5%\n* Recognize their primary care provider as their main diabetes care provider\n* Do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in English) to participate in shared decision-making (per provider?s assessment)\n* Have no plans to relocate out of town in the next 6 months\n* Enrolment is open to males and females of diverse racial backgrounds'}, 'identificationModule': {'nctId': 'NCT00388050', 'briefTitle': 'Diabetes Medication Choice', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice', 'orgStudyIdInfo': {'id': '06-003513'}, 'secondaryIdInfos': [{'id': 'ADA #33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Medication Choice decision aid', 'description': 'Patients in this arm will discuss diabetes medication for glucose control with the help of a decision aid that covers five commonly prescribed anti-hyperglycemic medications.', 'interventionNames': ['Behavioral: Diabetes Medication Choice decision aid']}, {'type': 'OTHER', 'label': 'Usual Care', 'description': 'Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Diabetes Medication Choice decision aid', 'type': 'BEHAVIORAL', 'description': 'The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.', 'armGroupLabels': ['Diabetes Medication Choice decision aid']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Victor M. Montori, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Victor Montori', 'oldOrganization': 'Mayo Clini'}}}}