Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-31 @ 5:47 AM
Study NCT ID:
NCT00358033
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2006-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D012657', 'term': 'Self-Help Groups'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-14', 'studyFirstSubmitDate': '2006-07-24', 'studyFirstSubmitQcDate': '2006-07-26', 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes', 'Dyslipidemia', 'Hypertension', 'Coronary Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)\n* Eligible for CRRC discharge:\n\n 1. For DM patients:\n\n * HbA1c \\< 7.0 %,\n * BP \\< 130/85 mm Hg , and\n * LDL \\< 100 mg/dl;\n 2. For Non-DM patients:\n\n * BP \\< 140/90 mm Hg, and\n * LDL \\< 100 mg/dl;\n* Able and willing to sign informed consent.\n\nExclusion Criteria:\n\n* Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder);\n* Metastatic disease or terminal illness'}, 'identificationModule': {'nctId': 'NCT00358033', 'briefTitle': 'Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic', 'organization': {'class': 'FED', 'fullName': 'Providence VA Medical Center'}, 'officialTitle': 'Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic', 'orgStudyIdInfo': {'id': '12712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group intervention', 'description': 'pharmacist-led group intervention in behavioral and pharmacologic therapy', 'interventionNames': ['Behavioral: Counseling', 'Behavioral: Interactive Education', 'Behavioral: Group Support', 'Procedure: Pharmacologic case management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'individual', 'description': 'pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction', 'interventionNames': ['Behavioral: Counseling', 'Procedure: Pharmacologic case management']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'usual care'}], 'interventions': [{'name': 'Counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['group intervention', 'individual']}, {'name': 'Interactive Education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['group intervention']}, {'name': 'Group Support', 'type': 'BEHAVIORAL', 'armGroupLabels': ['group intervention']}, {'name': 'Pharmacologic case management', 'type': 'PROCEDURE', 'description': 'Provided by clinical pharmacists', 'armGroupLabels': ['group intervention', 'individual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02908', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence VAMC', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Wen-Chih Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Cardiologist', 'investigatorFullName': 'Wen-Chih Wu', 'investigatorAffiliation': 'Providence VA Medical Center'}}}}