- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101530
Improving Prevention of Heart Disease in Latinos (LUCHAR)
Partnership Programs to Reduce Cardiovascular Disparities - Latinos Using Cardio Health Actions to Reduce Risk
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80204
- Denver Health Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward Havranek, MD, Denver Health and Hospital Authority
- Principal Investigator: Sheana Bull, PhD, University of Colorado Denver/HSC Aurora
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-0621
- U01HL079208 (U.S. NIH Grant/Contract)
- U01HL079160 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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