Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-16 @ 9:40 AM
Study NCT ID:
NCT02373059
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2015-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision Making With Pharmaceutical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-06', 'studyFirstSubmitDate': '2015-02-16', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Involvement Questionnaire', 'timeFrame': 'Post-Visit up to 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient Knowledge regarding Diabetes treatments Questionnaire', 'timeFrame': 'post visit up to 2 weeks'}, {'measure': 'Patient Medication Adherence Questionnaire', 'timeFrame': '1 month post visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'A research study to enhance clinical discussion between patients and pharmacists using a shared decision making tool for type 2 diabetes or usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Diagnosed with type II diabetes by ICD-9 code for more than one year\n* HbA1c of 7%-9.5% within past 6 months\n* Prescribed three or less anti-hyperglycemic medications as indicated by the medication list within the medical record\n\nExclusion Criteria:\n\n* Prescribed insulin\n* Pregnancy\n* Appointment with provider within a month\n* Appointment with provider within the last month\n* Followed by endocrinology'}, 'identificationModule': {'nctId': 'NCT02373059', 'acronym': 'SDMPC', 'briefTitle': 'Shared Decision Making With Pharmaceutical Care', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Examining the Use of a Shared Decision Making Tool With Pharmaceutical Care in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '14-009665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmaceutical care with shared decision making', 'description': 'Use of Diabetes Issue Cards Decision Aids', 'interventionNames': ['Other: Diabetes Issue Cards Decision Aids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Pharmaceutical care', 'description': 'Usual Care', 'interventionNames': ['Other: Usual Pharmaceutical Care']}], 'interventions': [{'name': 'Diabetes Issue Cards Decision Aids', 'type': 'OTHER', 'armGroupLabels': ['Pharmaceutical care with shared decision making']}, {'name': 'Usual Pharmaceutical Care', 'type': 'OTHER', 'armGroupLabels': ['Usual Pharmaceutical care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55944', 'city': 'Kasson', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Kasson', 'geoPoint': {'lat': 44.02996, 'lon': -92.75074}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Pharmacy', 'investigatorFullName': 'Joseph R. Herges, Pharm.D., R.Ph.', 'investigatorAffiliation': 'Mayo Clinic'}}}}