Phase 4
Completed N=525
Reducing Total Cardiovascular Risk in an Urban Community
Source: ClinicalTrials.gov NCT00241904 ↗Enrolled (actual)
525
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Low-density Lipoprotein Cholesterol — 100.1; 110.6 mg/dL — p=<0.001
◆ Published Evidence
Highly cited
193citations · ~13 / year
Community Outreach and Cardiovascular Health (COACH) Trial: a randomized, controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers.
Summary
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.
Linked Publications
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Community Outreach and Cardiovascular Health (COACH) Trial: a randomized, controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low-density Lipoprotein Cholesterol |
100.1; 110.6 | <0.001 sig |
| PRIMARY Systolic Blood Pressure |
130.8; 135.9 | 0.003 sig |
| PRIMARY HbA1c |
8.3; 8.2 | 0.034 sig |
| SECONDARY Patients' Satisfaction With Care and Health Care Utilization |
2.9; 1.8 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00241904) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.