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Novel Strategies for Reducing Heart Disease Risk Disparities (HeartSCORE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Steven E. Reis, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00143923
First received: September 1, 2005
Last updated: May 3, 2017
Last verified: May 2017
  Purpose

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 Intervention
Cardiovascular Diseases Behavioral: Nutrition, Exercise, Stress Management Counseling Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Heart Strategies Concentrating On Risk Evaluation (Heart SCORE) Study

Further study details as provided by Steven E. Reis, MD, University of Pittsburgh:

Primary Outcome Measures:
  • CVD Events [ Time Frame: 20 years ]
    Major adverse cardiovascular events


Enrollment: 2000
Study Start Date: March 2003
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  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.
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143923

Locations
United States, Pennsylvania
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
  More Information

Responsible Party: Steven E. Reis, MD, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00143923     History of Changes
Other Study ID Numbers: 0301102
PA DOH ME-02-384 ( Other Grant/Funding Number: Commonwealth of Pennsylvania )
Study First Received: September 1, 2005
Last Updated: May 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Steven E. Reis, MD, University of Pittsburgh:
Cardiovascular Diseases
Ethnic Groups
Risk Factors
Sleep disordered breathing
Environmental exposures
Cognitive Function

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 23, 2017