Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT00277732
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2006-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-11'}, 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2006-01-13', 'studyFirstSubmitQcDate': '2006-01-13', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference between the study groups in the change of blood glucose and HbA1c', 'timeFrame': 'baseline and after 6 months'}], 'secondaryOutcomes': [{'measure': 'Knowledge about diabetes and treatment', 'timeFrame': 'after 6 months'}, {'measure': 'Therapy adherence'}, {'measure': 'Body Mass Index', 'timeFrame': 'after 6 months'}, {'measure': 'Periods of severe hypoglycemia'}, {'measure': 'GP visits, emergency room visits and hospitalisations'}, {'measure': 'Work days lost'}, {'measure': 'Frequency of eye and foot examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ugent.be', 'label': 'Website University Ghent'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 45-75 years\n* Body Mass Index \\>= 25\n* Diabetes treatment for at least 12 months\n* Regular visitors of the participating community pharmacy\n\nExclusion Criteria:\n\n* Patients taking only insulin (no oral antidiabetic drugs)'}, 'identificationModule': {'nctId': 'NCT00277732', 'briefTitle': 'Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2005/340'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pharmaceutical care at baseline and follow-up visits over 6 months', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Mimi Giri, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}}}}