HeartSCORE: Novel Strategies for Reducing Heart Disease Risk Disparities

Sponsor

University of Pittsburgh (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00143923

Collaborator

Pennsylvania Department of Health (Other)

2,000

Enrollment

Location

Arms

261.1

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Behavioral: Nutrition, Exercise, Stress Management Counseling Other: usual care	N/A

Detailed 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:

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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Heart Strategies Concentrating On Risk Evaluation (Heart SCORE) Study

Study Start Date :

Mar 1, 2003

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Intervention: 6 months of individualized advice regarding Nutrition, Exercise, Stress Management Counseling for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 1	Behavioral: Nutrition, Exercise, Stress Management Counseling Individualized advice
Placebo Comparator: 2 Intervenition: 6 months of Usual care for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 2. No active Nutrition, Exercise, Stress Management Counseling	Other: usual care usual care
No Intervention: 3 No intervention for all participants who are at low Framingham risk for CVD or have preexisting CVD prior to study entry/ No active Nutrition, Exercise, Stress Management Counseling

Arm

Intervention/Treatment

Active Comparator: 1

Intervention: 6 months of individualized advice regarding Nutrition, Exercise, Stress Management Counseling for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 1

Behavioral: Nutrition, Exercise, Stress Management Counseling

Individualized advice

Placebo Comparator: 2

Intervenition: 6 months of Usual care for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 2. No active Nutrition, Exercise, Stress Management Counseling

Other: usual care

usual care

No Intervention: 3

No intervention for all participants who are at low Framingham risk for CVD or have preexisting CVD prior to study entry/ No active Nutrition, Exercise, Stress Management Counseling

Outcome Measures

Primary Outcome Measures

CVD Events [20 years]
Major adverse cardiovascular events

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

University of Pittsburgh
Pennsylvania Department of Health

Investigators

Principal Investigator: Steven E Reis, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven E. Reis, MD, Professor of Medicine, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00143923

Other Study ID Numbers:

0301102
PA DOH ME-02-384

First Posted:

Sep 2, 2005

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Steven E. Reis, MD, Professor of Medicine, University of Pittsburgh

Cardiovascular Diseases

Ethnic Groups

Risk Factors

Sleep disordered breathing

Environmental exposures

Cognitive Function

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Apr 7, 2022