Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatments nutrition, exercise, stress management counseling, usual care
Sponsor University of Pittsburgh
Collaborator Pennsylvania Department of Health
Start date March 2003
End date December 2024
Trial size 2000 participants
Trial identifier NCT00143923, 0301102, PA DOH ME-02-384

Summary

This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify disparities in cardiovascular risk based on race, socioeconomic status, and geographic location, (3) evaluate mechanisms for population differences in cardiovascular risk, and (4) implement a multidisciplinary community-based intervention program to decrease cardiovascular risk in high-risk populations. These goals, which are designed to eliminate ethnic and racial health disparities, are closely tied to the National Initiative to Eliminate Racial and Ethnic Disparities in Health and the nation's health promotion and disease prevention agenda established in Healthy People 2010.

This is a prospective cohort study of 2,000 residents of the state of Pennsylvania with approximately equal representation of white and African American subjects. All participants will undergo assessments of traditional and nontraditional risk factors to identify and determine the mechanisms of population disparities in cardiovascular risk. 800 participants who are at intermediate or high risk of cardiovascular disease will be randomly assigned to either (1) usual care/"advice only"; or (2) a multidisciplinary behavioral modification program to determine the most effective approach to reduce or eliminate racial, socioeconomic and geographic disparities in cardiovascular risk. All participants will undergo long-term follow-up for cardiovascular events.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Individualized advice regarding diet and exercise- for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 1
nutrition, exercise, stress management counseling
Individualized advice
(Placebo Comparator)
Usual care- for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 2
usual care
usual care
(No Intervention)
Usual care- for all participants who are at low Framingham risk for CVD or have preexisting CVD prior to study entry

Primary Outcomes

Measure
Cardiovascular Risk Factors
time frame: 20 years

Secondary Outcomes

Measure
CVD events
time frame: 20 years

Eligibility Criteria

Male or female participants from 45 years up to 75 years old.

Inclusion Criteria: - Men and women age 45-75 years Exclusion Criteria: - Comorbidity that is expected to limit life expectancy to <5 years - Inability to undergo baseline or annual follow-up visits - Pregnancy (exclude women from Xray studies)

Additional Information

Official title Heart Strategies Concentrating On Risk Evaluation (Heart SCORE) Study
Principal investigator Steven E Reis, MD
Description Well-established disparities exist in the prevalence and outcome of cardiovascular disease related to race and socioeconomic status (SES). Our previous work confirms these disparities and suggests that they may be related to population differences in the prevalence of nontraditional cardiovascular risk factors. We propose that these disparities can be significantly reduced or eliminated by (1) a community-based intervention program that incorporates a multidisciplinary education program led by a behavioral interventionalist, a nutritionist and an exercise physiologist, and (2) a novel approach to cardiovascular risk stratification that considers population differences in traditional and nontraditional risk factors and subclinical atherosclerosis. To successfully implement this program, particularly in traditionally underserved communities, we have formalized a partnership between the University of Pittsburgh School of Medicine and Graduate School of Public Health, the Pittsburgh Mind-Body Center, and the Pittsburgh Theological Seminary, Urban League of Pittsburgh, and Jewish Healthcare Foundation. This partnership is positioned to study the following specific aims: 1. To determine whether a community-based intervention program that incorporates a multidisciplinary education program led by a behavioral interventionalist, a nutritionist, and an exercise physiologist can reduce racial and socioeconomic disparities in cardiovascular risk in intermediate and high risk populations. 2. To ascertain whether a comprehensive assessment of nontraditional risk factors and subclinical atherosclerosis can provide incremental value above and beyond traditional risk assessment in identifying individuals at high cardiovascular risk.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Pittsburgh.