Heart Disease on the Mend

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients

Conditions
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Coronary Heart Disease, Stroke, Hyperlipidemia, Hypertension

Intervention / Treatment
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* Behavioral: Enhance health lifestyle changes and medication compliance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Enhance health lifestyle changes and medication compliance|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease risk score |  |  | 
| Low-density lipoprotein (LDL)-cholesterol |  |  | 
| Systolic blood pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) |  |  | 
| Physical activity score |  |  | 
| Nutrition score |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk factor reduction, cardiovascular disease prevention