Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT00533494
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2007-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Patients' Participation in Improving Diabetes Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-04', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-11', 'studyFirstSubmitDate': '2007-09-20', 'studyFirstSubmitQcDate': '2007-09-20', 'lastUpdatePostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c, LDL, systolic blood pressure', 'timeFrame': 'Baseline and 1 year after 1-year intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Despite the advent of efficacious medicines, there is a gap between ideal and actual care in the achievement of recommended outcomes among diabetic patients. The study enrolled 429 diabetic patients attending four HMO clinics in Israel, two in the northern region and two in the southern region. All clinics were randomly selected from all clinics affiliated with the Faculty of Health Sciences of the Ben Gurion University. The objective of the study was to compare the effects of a multi-component physician-patient intervention to physician feedback alone on a combined outcome of diabetes, blood pressure and serum lipids control. We hypothesized that in medical practices where physicians have received feedback on quality of care indicators, patients who received a letter encouraging them to discuss a list of important diabetes-related issues with their doctors, would experience better outcomes compared to patients who did no received such a letter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known diabetic patients enrolled in the four primary care clinics\n* Age 30 years and older.\n\nExclusion Criteria:\n\n* Below age 30 years\n* Type 1 diabetes\n* Spoke neither Hebrew nor Russian\n* Bedridden or confined to home.'}, 'identificationModule': {'nctId': 'NCT00533494', 'briefTitle': "The Effect of Patients' Participation in Improving Diabetes Care", 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'orgStudyIdInfo': {'id': 'sor166899ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Feedback to physicians + reminder letters to patients', 'interventionNames': ['Behavioral: physician feedback (A)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Feedback information to physicians', 'interventionNames': ['Behavioral: physician feedback (A)']}], 'interventions': [{'name': 'physician feedback (A)', 'type': 'BEHAVIORAL', 'description': 'Feedback information to physicians', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheva, Afula, Migdal Haemek', 'country': 'Israel', 'facility': 'Clalit Health Services'}], 'overallOfficials': [{'name': 'Shimon Weitzman, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Epidemiology- Faculty of Health Sciences-Ben Gurion University'}, {'name': 'Hava Tabenkin, MD, LLB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Family Medicine, Afula - Clalit Health Services'}, {'name': 'Sheldon Greenfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, School of Medicine,UCI'}, {'name': 'Sherrie H Kaplan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, School of Medicine,ICI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}}}}