Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 10:22 PM
Study NCT ID:
NCT01580904
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Pharmaceutical Care in Diabetics Patients
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': 'patriciatrindad@yahoo.com.br', 'phone': '558387010977', 'title': 'Impacto da Atenção Farmacêutica em pacientes diabéticos (IPCD)', 'organization': 'Universidade Estadual da Paraíba'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Patients will not be followed by the pharmacist.', 'otherNumAtRisk': 42, 'otherNumAffected': 30, 'seriousNumAtRisk': 42, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Intervention Group', 'description': 'Patients will be followed by the pharmacist.\n\nIntervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice', 'otherNumAtRisk': 47, 'otherNumAffected': 32, 'seriousNumAtRisk': 47, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Queasiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycated Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients will not be followed by the pharmacist.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients will be followed by the pharmacist.\n\nIntervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'average glycated hemoglobin over 24 weeks', 'unitOfMeasure': 'percent (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are glycated hemoglobin means of all patients per group.'}, {'type': 'PRIMARY', 'title': 'Fasting Glycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients will not be followed by the pharmacist.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.\n\nIntervention: Pharmaceutical Care\n\nIntervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice'}], 'classes': [{'categories': [{'measurements': [{'value': '157.7', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '159.3', 'spread': '56.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'average fasting glycemia over 24 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients will not be followed by the pharmacist.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.\n\nIntervention: Pharmaceutical Care\n\nIntervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice'}], 'classes': [{'categories': [{'measurements': [{'value': '209.9', 'spread': '42.8', 'groupId': 'OG000'}, {'value': '191.1', 'spread': '36.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'average total cholesterol over 24 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Patients will not be followed by the pharmacist.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.\n\nIntervention: Pharmaceutical Care\n\nIntervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice'}], 'classes': [{'categories': [{'measurements': [{'value': '131.0', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '110.8', 'spread': '32.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'average LDL cholesterol over 24 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Patients will be followed by the pharmacist.\n\nIntervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Patients will not be followed by the pharmacist.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'From September 2009 to December 2011.Medical clinic', 'preAssignmentDetails': 'The exclusion criteria were (i) to have an infectious disease during the study, (ii) to miss three consecutive appointments, (iii) to stop the use of the hypoglycemic drugs by order of the doctor, and (iv) to deny the acceptance of the term of free and informed consent (TFIC).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Patients will be followed by the pharmacist.\n\nIntervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Patients will not be followed by the pharmacist.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2012-04-11', 'resultsFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2012-04-17', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-19', 'studyFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated Hemoglobin', 'timeFrame': 'Up to 24 weeks', 'description': 'average glycated hemoglobin over 24 weeks'}, {'measure': 'Fasting Glycemia', 'timeFrame': 'Up to 24 weeks', 'description': 'average fasting glycemia over 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Total Cholesterol', 'timeFrame': 'Up to 24 weeks', 'description': 'average total cholesterol over 24 weeks'}, {'measure': 'LDL Cholesterol', 'timeFrame': 'Up to 24 weeks', 'description': 'average LDL cholesterol over 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pharmaceutical Care', 'Diabetics patients', 'Clinical trial'], 'conditions': ['Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '21616627', 'type': 'BACKGROUND', 'citation': "Mitchell B, Armour C, Lee M, Song YJ, Stewart K, Peterson G, Hughes J, Smith L, Krass I. Diabetes Medication Assistance Service: the pharmacist's role in supporting patient self-management of type 2 diabetes (T2DM) in Australia. Patient Educ Couns. 2011 Jun;83(3):288-94. doi: 10.1016/j.pec.2011.04.027. Epub 2011 May 26."}], 'seeAlsoLinks': [{'url': 'http://www.pharmacypractice.org/', 'label': 'A journal that has a lot of research on this topic'}, {'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2387287/', 'label': 'An interesting article on this topic'}]}, 'descriptionModule': {'briefSummary': 'The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p \\<0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Inclusion criteria:\n\n* patients aged 30 years,\n* diagnosed with type 2 diabetes,\n* to make use of oral antidiabetic agents with or without insulin\n\nExclusion Criteria:\n\nthose who had infectious diseases during the research\n\n* missed three consecutive interviews,\n* suspended the hypoglycemic drug and medical order'}, 'identificationModule': {'nctId': 'NCT01580904', 'acronym': 'IPCD', 'briefTitle': 'Impact of Pharmaceutical Care in Diabetics Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual da Paraiba'}, 'officialTitle': 'Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients', 'orgStudyIdInfo': {'id': 'UEParaiba'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients will not be followed by the pharmacist.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.\n\nIntervention: Pharmaceutical Care', 'interventionNames': ['Behavioral: Intervention: Pharmaceutical Care']}], 'interventions': [{'name': 'Intervention: Pharmaceutical Care', 'type': 'BEHAVIORAL', 'description': 'Patients will be followed by the pharmacist by the Pharmaceutical Care Practice', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Universidade Estadual da Paraíba', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}], 'overallOfficials': [{'name': 'Ivonete A. Doutorado', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal do Rio Grande do Norte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual da Paraiba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Impact of Pharmaceutical Care in Diabetics Patients: Clinical Trial Randomized', 'investigatorFullName': 'Patrícia Trindade Costa Paulo', 'investigatorAffiliation': 'Universidade Estadual da Paraiba'}}}}