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Home > "C" Clinical Trials Conditions > Community Site Coronary Risk Control in Black Families  Community Site Coronary Risk Control in Black Families
Community Site Coronary Risk Control in Black Families
For Condition: Cardiovascular Diseases,Heart Diseases,Coronary Heart Disease Risk Reduction,Coronary Disease
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: BACKGROUND: 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. DESIGN NARRATIVE: The study recruited 480 siblings of individuals with early coronary disease to identify 433 who were eligible for randomization by family to a usual care or NHW/N case management for 1 year follow up with an anticipated follow-up of 390 individuals. 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).
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DianeBecker, , Johns Hopkins University
Additional Information:
Study ID Numbers: 5012;
Study Start Date: April 1998
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005746
Other Coronary Disease Studies:
1. Women's Antioxidant and Cardiovascular Study (WACS)
2. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH)
3. Antecedents of the Type A Behavior Pattern
4. National Heart, Lung, and Blood Institute Twin Study
5. Community Site Coronary Risk Control in Black Families
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Community Site Coronary Risk Control in Black Families
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