Cardiovascular DiseasesLUCHARNCT00101530
Improving Prevention of Heart Disease in Latinos
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: White and Latino patients in a safety net hospital
Eligibility Criteria vary with each study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Official title: Partnership Programs to Reduce Cardiovascular Disparities - Latinos Using Cardio Health Actions to Reduce Risk
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.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2005 (estimated)
- Study startSep 2004
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Edward Havranek, MD, Principal investigator, Denver Health and Hospital AuthoritySheana Bull, PhD, Principal investigator, University of Colorado Denver/HSC Aurora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101530
- Sponsor's protocol ID
- 04-0621
- Other IDs
- U01HL079208, U01HL079160
- Acronym
- LUCHAR
- Status last verified
- Sep 2015
- First submitted
- 10 Jan 2005
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership Programs to Reduce Cardiovascular Disparities - Latinos Using Cardio Health Actions to Reduce Risk
- ClinicalTrials.gov ID
- NCT00101530
- Acronym / sponsor ID
- LUCHAR / 04-0621
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- White and Latino patients in a safety net hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Havranek, MD principal investigator
Denver Health and Hospital Authority
Sheana Bull, PhD principal investigator
University of Colorado Denver/HSC Aurora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.