Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-01 @ 7:54 AM
Study NCT ID:
NCT01861756
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2013-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Diabetes Medication Choice Cards Trial in Greece
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'atsapas@auth.gr', 'title': 'Dr. Apostolos Tsapas', 'organization': 'Aristotle University Thessaloniki'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Diabetes Medication Choice Decision Aid', 'otherNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'otherNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Decisional Comfort (0-100, 100=no Conflict)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Medication Choice Decision Aid'}, {'id': 'OG001', 'title': 'Usual Care'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '94'}, {'value': '75.1', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '89.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Quality of the decision making process assessed by means of the Decisional Conflict Scale', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Degree of Patient Knowledge About Available Treatment Alternatives', 'timeFrame': 'Day 1', 'description': 'Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient and Clinician Satisfaction With the Decision Making Process', 'timeFrame': 'Day 1', 'description': 'Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support.\n\nClinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records', 'timeFrame': '3 and 6 months after patient initial encounter', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Glycemic Control (HbA1c)', 'timeFrame': '3 and 6 months after patient initial encounter', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diabetes Medication Choice Decision Aid'}, {'id': 'FG001', 'title': 'Usual Care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Diabetes Medication Choice Decision Aid'}, {'id': 'BG001', 'title': 'Usual Care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '11', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type 2 diabetes duration', 'classes': [{'categories': [{'title': '<5 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '5 - 10 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '>10 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'missing data', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2013-05-20', 'resultsFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-23', 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Decisional Comfort (0-100, 100=no Conflict)', 'timeFrame': 'Day 1', 'description': 'Quality of the decision making process assessed by means of the Decisional Conflict Scale'}], 'secondaryOutcomes': [{'measure': 'Degree of Patient Knowledge About Available Treatment Alternatives', 'timeFrame': 'Day 1', 'description': 'Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.'}, {'measure': 'Patient and Clinician Satisfaction With the Decision Making Process', 'timeFrame': 'Day 1', 'description': 'Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support.\n\nClinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient.'}, {'measure': 'Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records', 'timeFrame': '3 and 6 months after patient initial encounter'}, {'measure': 'Glycemic Control (HbA1c)', 'timeFrame': '3 and 6 months after patient initial encounter'}]}, 'conditionsModule': {'keywords': ['Shared Decision Making', 'Decision Aids'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '28186933', 'type': 'DERIVED', 'citation': 'Karagiannis T, Liakos A, Branda ME, Athanasiadou E, Mainou M, Boura P, Goulis DG, LeBlanc A, Montori VM, Tsapas A. Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial. BMJ Open. 2016 Nov 14;6(11):e012185. doi: 10.1136/bmjopen-2016-012185.'}]}, 'descriptionModule': {'briefSummary': 'A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus for more than one year\n* Agree to be followed for at least 6 months\n* Willing to respond to survey questions immediately following the visit\n* HbA1c value between 7.5% and 10%\n* Need treatment intensification and there are more than one available treatment options\n\nExclusion Criteria:\n\n* Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment\n* Is to transfer to another practice within the next 6 months\n* Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid\n* Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge\n* Enrolled in other studies that require prolonged participation and follow-up\n* Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making\n* Women known to be pregnant'}, 'identificationModule': {'nctId': 'NCT01861756', 'briefTitle': 'The Diabetes Medication Choice Cards Trial in Greece', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'The Diabetes Medication Choice Cards Trial in Greece', 'orgStudyIdInfo': {'id': 'AUTH87963'}, 'secondaryIdInfos': [{'id': 'U1111-1138-2901', 'type': 'OTHER', 'domain': 'WHO - Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Medication Choice Decision Aid', 'interventionNames': ['Other: Diabetes Medication Choice decision aid']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care'}], 'interventions': [{'name': 'Diabetes Medication Choice decision aid', 'type': 'OTHER', 'description': 'The Diabetes Medication Choice decision aid cards provide information about medications commonly used to treat type 2 diabetes mellitus. The tool was originally developed and successfully evaluated by Mayo Clinic researchers.', 'armGroupLabels': ['Diabetes Medication Choice Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Piraeus', 'state': 'Attica', 'country': 'Greece', 'facility': 'Tzanio General Hospital', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'city': 'Neapoli', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Private practice', 'geoPoint': {'lat': 40.6532, 'lon': 22.94156}}, {'city': 'Néa Michanióna', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Nea Michaniona Health Center', 'geoPoint': {'lat': 40.46371, 'lon': 22.8617}}, {'city': 'Thermi', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Thermi S.A.', 'geoPoint': {'lat': 40.54712, 'lon': 23.01967}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'Alexandroupoli University Hospital', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'NIMTS Military Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Polikliniki General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Serres', 'country': 'Greece', 'facility': 'Private practice', 'geoPoint': {'lat': 41.08499, 'lon': 23.54757}}], 'overallOfficials': [{'name': 'Apostolos Tsapas, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Foundation for the Study of Diabetes', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Apostolos Tsapas', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}