drugset / Trial / NCT00241904

Reducing Total Cardiovascular Risk in an Urban Community

NCT00241904 ↗

Phase 4 Completed 525 enrolled Johns Hopkins University National Heart, Lung, and Blood Institute (NHLBI) · collab

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2006-05
Primary completion: 2010-05
Completion: 2010-05

Outcome

Mixed primary results

registry MEAN Comprehensive Intervention Group: 100.1 (Standard Deviation 39.2) mg/dL NCT00241904 ↗

registry MEAN Less Intensive Intervention Group: 110.6 (Standard Deviation 36.8) mg/dL NCT00241904 ↗

registry analysis (superiority test); Comprehensive Intervention Group vs Less Intensive Intervention Group; p <0.001; General Linear Mixed Model NCT00241904 ↗

registry MEAN Comprehensive Intervention Group: 130.8 (Standard Deviation 20.7) mmHg NCT00241904 ↗

registry MEAN Less Intensive Intervention Group: 135.9 (Standard Deviation 20.5) mmHg NCT00241904 ↗

registry analysis (superiority test); Comprehensive Intervention Group vs Less Intensive Intervention Group; p = 0.003; General Linear Mixed Model NCT00241904 ↗

registry MEAN Comprehensive Intervention Group: 8.3 (Standard Deviation 2.2) percentage of hemoglobin NCT00241904 ↗

registry MEAN Less Intensive Intervention Group: 8.2 (Standard Deviation 2.1) percentage of hemoglobin NCT00241904 ↗

registry analysis (superiority test); Comprehensive Intervention Group vs Less Intensive Intervention Group; p = 0.034; General Linear Mixed Model NCT00241904 ↗

Publications

Allen JK, Dennison-Himmelfarb CR, Szanton SL, Bone L, Hill MN, Levine DM, West M, Barlow A, Lewis-Boyer L, Donnelly-Strozzo M, Curtis C, Anderson K. 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. Circ Cardiovasc Qual Outcomes. 2011 Nov 1;4(6):595-602. doi: 10.1161/CIRCOUTCOMES.111.961573. Epub 2011 Sep 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACE Inhibitors	Unknown	—	Oral
Subject	Aspirin	Small molecule	81 mg	—
Subject	Atenolol	Other / unclassified	—	Oral
Subject	Metoprolol	Other / unclassified	—	Oral
Subject	Propranolol	Small molecule	—	Oral