Heart Disease on the Mend
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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.
Condition | Intervention | Phase |
---|---|---|
Coronary Heart Disease Stroke Hyperlipidemia Hypertension |
Behavioral: Enhance health lifestyle changes and medication compliance |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients |
- Cardiovascular disease risk score
- Low-density lipoprotein (LDL)-cholesterol
- Systolic blood pressure
- Body mass index (BMI)
- Physical activity score
- Nutrition score
Estimated Enrollment: | 150 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | May 2003 |
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.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women ≥ 35 years
- One or more major risk factors
- Live in Santa Clara County
- Low family income that limits access to medical care
Exclusion Criteria:
- Under active medical treatment for cancer, CVD or other major medical disorder
- Reasonable access to health care
- Under 35 years of age
- Not a resident of Santa Clara County
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | William L Haskell, PhD | Stanford University |
No publications provided
ClinicalTrials.gov Identifier: | NCT00127751 History of Changes |
Other Study ID Numbers: | 373765 |
Study First Received: | August 5, 2005 |
Last Updated: | August 24, 2005 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Stanford University:
Risk factor reduction cardiovascular disease prevention |
Additional relevant MeSH terms:
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Hyperlipidemias Hypertension Stroke Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on October 16, 2012