Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00127751
Status:
COMPLETED
Last Update Posted:
2005-08-25
First Post:
2005-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heart Disease on the Mend
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2003-05'}, 'lastUpdateSubmitDate': '2005-08-24', 'studyFirstSubmitDate': '2005-08-05', 'studyFirstSubmitQcDate': '2005-08-05', 'lastUpdatePostDateStruct': {'date': '2005-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular disease risk score'}, {'measure': 'Low-density lipoprotein (LDL)-cholesterol'}, {'measure': 'Systolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Body mass index (BMI)'}, {'measure': 'Physical activity score'}, {'measure': 'Nutrition score'}]}, 'conditionsModule': {'keywords': ['Risk factor reduction', 'cardiovascular disease prevention'], 'conditions': ['Coronary Heart Disease', 'Stroke', 'Hyperlipidemia', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life.', 'detailedDescription': 'The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life. Subjects were primarily recruited from patients being seen in free medical clinics in Santa Clara County California. Primary eligibility was ≥ 35 years of age, one or more CVD risk factors (with or without clinical CVD), low family income, and residing in Santa Clara County. Patients in the case management group were provided counseling services by specially trained registered nurses (RNs) and registered dieticians (RDs) and assisted in obtaining medications and medical services from programs provided in the county or indigent drug programs provided by selected pharmaceutical companies. Protocol driven treatment algorithms based on national practice guidelines were used and use of existing programs and resources were maximized. On average patients in case management were seen by staff 6-9 in the 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 35 years\n* One or more major risk factors\n* Live in Santa Clara County\n* Low family income that limits access to medical care\n\nExclusion Criteria:\n\n* Under active medical treatment for cancer, CVD or other major medical disorder\n* Reasonable access to health care\n* Under 35 years of age\n* Not a resident of Santa Clara County'}, 'identificationModule': {'nctId': 'NCT00127751', 'briefTitle': 'Heart Disease on the Mend', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients', 'orgStudyIdInfo': {'id': '373765'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enhance health lifestyle changes and medication compliance', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'William L Haskell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Health Trust of Santa Clara County', 'class': 'UNKNOWN'}]}}}