Hypertension Clinical Trial
— COACHOfficial title:
Reducing Total Cardiovascular Risk in an Urban Community
Verified date | February 2014 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON
FAMILY HEALTH CENTER.
The purpose of this study is to compare the clinical effectiveness and cost effectiveness of
two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention
with a less intensive (LI) intervention - in African American, and white low-income patients
with known excessive cardiovascular disease risk.
Status | Completed |
Enrollment | 525 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Currently receiving medical care at Johns Hopkins University - African American or Caucasian and have diagnosed CVD, defined as a prior myocardial infarction, revascularization procedure for coronary disease, ischemic heart disease, stroke, or have diagnosed type 2 diabetes and not receiving any therapy - Have either no LDL-C in their medical record during the 12 months prior to study entry or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering pharmacotherapy - Have either no blood pressure recorded in their medical record during the 12 months prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if the participant is diabetic or has renal insufficiency - If the participant is diabetic he or she has to either have no HbA1c recorded during the 12 months prior to study entry or HbA1c of 7 percent or greater Exclusion criteria: - A serious life-threatening noncardiac comorbidity with a life expectancy of less than 5 years - A serious physician-recorded psychiatric morbidity that would interfere with the study - Sufficient neurological impairment that would interfere with the study |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LDL-C | Measured at 1 year | No | |
Primary | Blood pressure | Measured at 1 year | No | |
Primary | HbA1c, if diabetic | Measured at 1 year | No | |
Primary | Physical activity | Measured at 1 year | No | |
Primary | Smoking cessation or reduction, if current tobacco smoker | Measured at 1 year | No | |
Primary | Prescribed antiplatelet agents/anticoagulants, if coronary artery disease patient | Measured at 1 year | No | |
Primary | Prescribed ß- Blockers, if coronary artery disease patient | Measured at 1 year | No | |
Primary | Prescribed ACE inhibitors, if post myocardial infarction patient | Measured at 1 year | No | |
Secondary | Patients' satisfaction with care and health care utilization | Measured at 1 year | No |
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