Community Site Coronary Risk Control in Black Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005746
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 18, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To test the effectiveness of a community site neighborhood health worker/nurse (NHW/N) case management strategy for coronary heart disease risk reduction compared with usual care in apparently healthy African American siblings of persons with documented premature coronary heart disease.

Condition or disease
Cardiovascular Diseases Heart Diseases Coronary Disease Coronary Heart Disease Risk Reduction

Detailed Description:


The rationale for this program proceeded from the markedly increased risk of initial coronary events in siblings with coronary artery disease with onset before age 50. There is an excess of treatable coronary heart disease risk factors in such siblings and a high prevalence of adult atherosclerosis.


The study recruited 364 siblings of individuals with early coronary disease. Eligible subjects were randomized to community-based care (CBC) or enhanced primary care (EPC) with a community health site neighborhood health worker/nurse for 1 year follow up. Intervention participants were stratified based on results of treadmill testing to either more or less aggressive management of their lipids according to National Cholesterol Education Program guidelines. All positive participants on the exercise stress test were directly referred to their physicians. Diabetics were referred to their primary physician for treatment. Intervention in the intervention group was carried out on traditional coronary heart disease (CHD) risk factors including diet, physical activity, blood pressure, LDL cholesterol, and cigarette smoking. The intervention built on a prior sibling study in Blacks and whites.

The approach was that, rather than carrying out the intervention at the central John Hopkins Clinic, thus requiring transportation of potentially anxious participants to a strange environment, the new interventions were carried out by trained local NHWs in a more accessible local community site. The nutrition interventions used fat counters that focused on total fat gram goals, and intervention was carried out by the NHW/N with assistance from cookbooks appropriate for African American households. Siblings were requested to come monthly for dietary counseling. Smoking cessation interventions used individual counseling previously carried out by the investigators. Smoking assessment included self-report and measures of carbon monoxide (CO) in expired air. Study physicians carried out pharmacologic interventions for blood pressure, lipids and lipoproteins. Diabetes treatment was through referral to the patient's private physician. Nurses provided oversight to NHWs.

Neighborhood health workers were trained and certified in taking blood pressure (BP), phlebotomy, and CO measurements at the Center for Health Promotion at Johns Hopkins, which had an NHW training program for blood pressure. Outcomes measures included changes in blood pressure, smoking behavior, and plasma concentrations of lipids and lipoproteins. Attention was paid to potential modifying factors such as demographic factors (e.g., education, socioeconomic status, income, occupation).

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type : Observational
Study Start Date : April 1998
Actual Study Completion Date : March 2003

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Healthy Black siblings of individuals with premature coronary disease. Over 60% were women. Sibs were eligible if they were aged between 30 and 59 years with no known history of CAD, no chronic glucocorticosteroid therapy, no autoimmune disease, no current cancer therapy, and no immediate life-threatening comorbidity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005746

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Diane Becker Johns Hopkins University