Status:
COMPLETED
Improving Coronary Prevention in a County Health System
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Coronary Disease
Eligibility:
All Genders
35-85 years
Phase:
NA
Brief Summary
To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program , a case management approach, can be effectively used to manage the risk of coronary artery disease.
Detailed Description
BACKGROUND: Evidence from extensive population studies and clinical trials shows the effectiveness of risk factor management in reducing morbidity and mortality from coronary artery disease (CAD). Th...
Eligibility Criteria
Inclusion
- Abbreviations: FBS = fasting blood sugar, SBP = systolic blood pressure, DBP = diastolic blood pressure, LDL = low-density lipoprotein, HDL = high-density lipoprotein, BMI = body mass index, TC = total cholesterol, TG = triglycerides, HbA1c = hemoglobin A1c.
- Inclusion Criteria
- The patient has CAD or CAD risk equivalent (abdominal aortic aneurysm, peripheral vascular disease, transient ischemic attack, stroke, diabetes, or FBS ≥ 126 mg/dL × 2) and has at least one of following: SBP ≥ 130 mmHg, DBP ≥ 80 mmHg, LDL ≥ 100 mg/dL, HDL ≤ 40 mg/dL, TG ≥ 150 mg/dL, FBS ≥ 126 mg/dL, BMI ≥ 30, or is a current smoker.
- The patient does not have CAD or CAD risk equivalent but has at least one of the following: SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, LDL ≥ 190 mg/dL, TC ≥ 240 mg/dL, TG ≥ 500 mg/dL, HbA1c ≥ 8.0%, BMI ≥ 35, or is a current smoker.
- The patient does not have CAD or CAD risk equivalent but has at least two of the following: a) SBP ≥ 140 mmHg or DBP ≤ 90 mmHg, b) HDL ≤ 40 mm/dL or TG ≥ 200 mg/dL, c) LDL ≥ 160 mg/dL or TC ≥ 240 mg/dL, d) FBS ≥ 110 mg/dL × 2, or e) male age ≥ 45 or female age ≥ 55 or with positive family history of CAD.
- Exclusion Criteria:
- Resident of long-term facility
- Lack of spoken English or Spanish by patient or household member 18 years or older who can serve as an interpreter
- Moving before end of intervention (30 months)
- Age between 35 and 85 (inclusive)
- Significant comorbidities such as: uncontrolled metabolic disorders (renal failure, liver failure, etc.), active symptoms suggesting acute myocardial infarction or decompensated congestive heart failure, Malignancy or other condition limiting life expectancy, psychiatric disorder with active manifestations.
- Substance abuse.
- No telephone or means of contacting patient.
- Family household member already enrolled.
- Homeless and not living with relatives/friends.
- Anticipated absence for more than 4 consecutive months.
- Difficulty coming to appointments approximately every 1-2 months
- Already participating in the Diabetes program
- Currently pregnant or intends to get pregnant the next 3 years.
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00128687
Start Date
April 1 2003
End Date
March 1 2008
Last Update
February 11 2014
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