Improving Prevention of Heart Disease in Latinos

Hypertension Clinical Trial

— LUCHAR  

Official title:

Partnership Programs to Reduce Cardiovascular Disparities - Latinos Using Cardio Health Actions to Reduce Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101530
• Other study ID #: 04-0621
• Secondary ID: U01HL079208U01HL
• Status: Completed
• Phase: N/A
• First received: January 10, 2005
• Last updated: September 29, 2015
• Start date: September 2004
• Est. completion date: June 2012

Study information

• Verified date: September 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to improve cardiovascular disease (CVD) outcomes in racial and ethnic minorities. Specifically, it seeks to improve the primary prevention of CVD in Hispanics.

Description:

BACKGROUND:

While there has been great progress in reducing CVD morbidity and mortality in the United States over the past 40 years, some minority groups have not shared fully in this progress and continue to have lower life expectancy and higher CVD morbidity. On average, minorities have less access to medical care, receive less aggressive care and fewer diagnostic and therapeutic cardiac procedures, and adhere poorly to prescribed medical regimens. Thus, research to reduce health disparities by improving CVD outcomes in minorities offers potential for a substantial positive public heath impact. Academic medical centers and institutions capable of carrying out such research, however, often lack access to and the trust of minority patients. Minority patients often receive fragmented care because they lack access to regular medical care, present to emergency departments rather than primary care physicians for complications of an advanced chronic CVD condition, and are less likely to follow medical regimens. Minority communities often harbor distrust of clinical research. Minority patients report greater satisfaction when receiving care from minority providers and are reluctant to receive treatment outside their minority health care serving systems.

In general, minorities have high rates of hypertension, elevated cholesterol, cigarette smoking, obesity, metabolic syndrome, and diabetes as well as other behavioral, environmental, and occupational risk factors for cardiovascular diseases, such as sleep problems - all elements that contribute to excess CVD morbidity and mortality. The causes of minority health disparities are complex and incompletely understood. Although evidence of genetic, biologic, and environmental factors is well documented, poor outcomes are also attributed to undertreatment. Such undertreatment may be due to limited access to health care or, in some cases, breakdown of the medical system, or failure of the physician and/or patient to allow for optimal health care, even when access is not impaired. The complex interactions of behavior, socioeconomic status (SES), culture, and ethnicity are important predictors of health outcomes and sources of health disparities. Despite efforts to elucidate genetic and environmental risk factors and to promote cardiovascular health in high-risk populations, trends in CVD outcomes suggest that CVD health disparities continue to widen.

The Partnerships Program to Reduce Cardiovascular Health Disparities involves collaboration between research-intensive medical centers (RIMCs) that have a record of NIH-supported research and patient care and minority health care serving systems (MSSs) that lack a strong research program. Each Partnership Program will (a) design and carry out multiple interdisciplinary research projects that investigate complex biological, behavioral, and societal factors that contribute to CVD health disparities and facilitate clinical research within the MSS to improve CVD outcomes and reduce health disparities and (b) provide reciprocal educational and skills development programs so that investigators are able to conduct research aimed at reducing cardiovascular disparities and thereby enhance research opportunities and enrich cultural sensitivity and cardiovascular research capabilities at both institutions.

The Request for Applications for Partnership Programs to Reduce Cardiovascular Disparities was released in September 2003. The awards were made in September 2004.

DESIGN NARRATIVE:

The study will develop a partnership between Denver Health (DH), an MSS, and the University of Colorado Health Sciences Center (UCHSC), an RIMC. The first specific aim of the project is to develop and evaluate an interactive computer-based tool to improve community-based recognition of cardiovascular risk factors and to improve self-management skills, including adherence with clinic visits. The tool will be culturally sensitive and bilingual. The second specific aim is to test the ability of a nurse-based disease management program to improve control of risk factors. Under this aim, DH's unique computerized information system will be used to develop a registry of patients with hypertension and to characterize patients' overall risk for CVD and their risk for nonadherent behavior. A randomized clinical trial will be used to assess the impact of a nurse-based disease management intervention in those at highest risk and with a history of nonadherence. The intervention will be based on programs already in place at DH but will be modified in response to input from community-based focus groups. Specific aims 3 and 4 will seek to refine current cardiovascular risk profiling in ways specific to Hispanics. Specific aim 3 will assess ethnic differences in the relationship between traditional risk factors (diabetes, hypertension, smoking, and hyperlipidemia) and preclinical markers of cardiovascular disease (left ventricular mass, carotid intima media thickness, and brachial artery reactivity) over time. Specific aim 4 will assess the relationship among the traditional risk factors, preclinical markers, and a panel of circulating inflammatory markers. Also under specific aim 4, a randomized, placebo-controlled trial will assess the efficacy of "statin" medications to reduce circulating levels of these inflammatory markers. Specific aims 5 and 6 will develop educational programs to increase the cultural proficiency of clinical researchers, increase minority researcher participation in cardiovascular prevention research, and assist junior DH physicians in developing research careers in cardiovascular prevention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older
• Eligibility: Eligibility Criteria vary with each study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Heart Diseases
• Hypertension

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,