Cardiovascular DiseasesNCT00101504
Hypertension Education and Treatment Partnership for Reducing Ethnic Differences in the Risk of Cardiovascular Disease
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
The purpose of this study is to improve hypertension outcomes in racial and ethnic minorities. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2004to Aug 2009
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
Official title: Partnership Programs to Reduce Cardiovascular Disparities - Hypertension Education and Treatment (HEAT)
The purpose of this study is to improve hypertension outcomes in racial and ethnic minorities.
Read the detailed description
BACKGROUND:
While there has been great progress in reducing CVD morbidity and mortality in the U.S. 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 healthcare 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 under-treatment. Such under-treatment may be due to limited access to health care or, in some cases, break-down 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, socio-economic 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 track record of NIH-supported research and patient care and minority healthcare 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 will be able to conduct research aimed at reducing cardiovascular disparities and thereby enhance research opportunities, enrich cultural sensitivity, and improve 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 University of Mississippi Medical Center (the Research Intensive Medical Center) and Jackson-Hinds Comprehensive Health Center (the Minority Healthcare Serving System) will address cardiovascular health disparities among African Americans through establishment of its HEAT Partnership. HEAT is an acronym for Hypertension Education and Treatment. The HEAT Partnership is organized into four cores. The administrative core includes the principal investigators from both the RIMC and the MSS as well as the core directors and co-directors. Specific aims of the Research Core are to: (1) provide a series of workshops for healthcare providers that focus on assessment and treatment of hypertensive patients according to current guidelines; (2) enroll a sufficient number of patients with uncontrolled hypertension to participate in the study and encourage each of them to continue treatment throughout the duration of the intervention as a means of promoting lifetime hypertension control; (3) provide a program of patient education that includes (a) a series of workshops for the intervention participants that focus on the impact of hypertension, and the efficacy of proper diet and exercise in managing hypertension; (b) a patient advocate, who will serve as a liaison between patient and provider; and (c) a "health partner" from the patient's social circle of acquaintances who will help reinforce the workshop lessons in a participatory manner; and (4) compare the results of the intervention group and the control group, and determine the effectiveness of the intervention. Specific aims of the Education Core are to: (1) enhance cultural competency among healthcare providers and address its impact on health disparities among the nation's racial and ethnic minority populations; (2) explore issues of race, racism, and health disparities in research and medical care, particularly as they affect African Americans in Mississippi; and (3) provide career development training for new investigators capable of conducting research to reduce cardiovascular health disparities. Specific aims of the Community Outreach Core are to: (1) conduct focus group sessions in selected vulnerable populations to assess the level of awareness about hypertension and identify realistic lifestyle hypertension-prevention goals for the intended audience; (2) pursue partnerships with community-based organizations to enhance the activities of the Outreach Core; and (3) develop and disseminate culturally and linguistically appropriate education materials to the lay public about hypertension, including detection, diagnosis, and strategies for its prevention.
The study completion date listed in this record was obtained from the "End Date" entered in the Query View Report (QVR) record.
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Heart Diseases
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
- Study completionAug 2009
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 National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Raymond Gordon, Principal investigator, Jackson Hinds Comprehensive Health CenterHerman Taylor, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101504
- Sponsor's protocol ID
- 1286
- Other IDs
- U01HL079378, U01HL079458
- Status last verified
- Apr 2006
- First submitted
- 10 Jan 2005
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership Programs to Reduce Cardiovascular Disparities - Hypertension Education and Treatment (HEAT)
- ClinicalTrials.gov ID
- NCT00101504
- Acronym / sponsor ID
- 1286
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2004
- Study completion
- Aug 2009 (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 this study is to improve hypertension outcomes in racial and ethnic minorities.
Detailed description
BACKGROUND:
While there has been great progress in reducing CVD morbidity and mortality in the U.S. 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 healthcare 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 under-treatment. Such under-treatment may be due to limited access to health care or, in some cases, break-down 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, socio-economic 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 track record of NIH-supported research and patient care and minority healthcare 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 will be able to conduct research aimed at reducing cardiovascular disparities and thereby enhance research opportunities, enrich cultural sensitivity, and improve 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 University of Mississippi Medical Center (the Research Intensive Medical Center) and Jackson-Hinds Comprehensive Health Center (the Minority Healthcare Serving System) will address cardiovascular health disparities among African Americans through establishment of its HEAT Partnership. HEAT is an acronym for Hypertension Education and Treatment. The HEAT Partnership is organized into four cores. The administrative core includes the principal investigators from both the RIMC and the MSS as well as the core directors and co-directors. Specific aims of the Research Core are to: (1) provide a series of workshops for healthcare providers that focus on assessment and treatment of hypertensive patients according to current guidelines; (2) enroll a sufficient number of patients with uncontrolled hypertension to participate in the study and encourage each of them to continue treatment throughout the duration of the intervention as a means of promoting lifetime hypertension control; (3) provide a program of patient education that includes (a) a series of workshops for the intervention participants that focus on the impact of hypertension, and the efficacy of proper diet and exercise in managing hypertension; (b) a patient advocate, who will serve as a liaison between patient and provider; and (c) a "health partner" from the patient's social circle of acquaintances who will help reinforce the workshop lessons in a participatory manner; and (4) compare the results of the intervention group and the control group, and determine the effectiveness of the intervention. Specific aims of the Education Core are to: (1) enhance cultural competency among healthcare providers and address its impact on health disparities among the nation's racial and ethnic minority populations; (2) explore issues of race, racism, and health disparities in research and medical care, particularly as they affect African Americans in Mississippi; and (3) provide career development training for new investigators capable of conducting research to reduce cardiovascular health disparities. Specific aims of the Community Outreach Core are to: (1) conduct focus group sessions in selected vulnerable populations to assess the level of awareness about hypertension and identify realistic lifestyle hypertension-prevention goals for the intended audience; (2) pursue partnerships with community-based organizations to enhance the activities of the Outreach Core; and (3) develop and disseminate culturally and linguistically appropriate education materials to the lay public about hypertension, including detection, diagnosis, and strategies for its prevention.
The study completion date listed in this record was obtained from the "End Date" entered in the Query View Report (QVR) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 12 Jul 2016.
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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.
Raymond Gordon principal investigator
Jackson Hinds Comprehensive Health Center
Herman Taylor principal investigator
University of Mississippi Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 12 Jul 2016.