Cardiovascular DiseasesNCT00101478
Improving Cardiovascular Treatment Approaches Among Minorities
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and ethnic minorities. Specifically, the study will aim to improve provider and patient approaches to treatment of hypertension and diabetes, respectively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus
- How many people
- 823 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Jan 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study groups will be selected from primary and family health clinics, community, and patients of physicians participating in the study.
Who may be able to join
- Uncontrolled hypertension or diabetes
Who cannot join
- Medical condition that would prevent treatment for hypertension at the University of Maryland
- Medical condition that would prevent treatment for diabetes at Bon Secours
- Uninsured
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Bon Secours Hospital
Baltimore, Maryland, 21223
About this study
Official title: Partnership Programs to Reduce Cardiovascular Disparities - Baltimore Partnership
The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and ethnic minorities. Specifically, the study will aim to improve provider and patient approaches to treatment of hypertension and diabetes, respectively.
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. These are 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 minority healthcare serving systems (MSSs) that lack a strong research program and research-intensive medical centers (RIMCs) that have a track record of NIH-supported research and patient care. 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, thereby enhancing research opportunities and enriching 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 collaborative partnership between the Bon Secours Baltimore Health System (BSBHS) and the University of Maryland Baltimore (UMB) seeks to improve provider and patient approaches to treatment of hypertension and diabetes, respectively. UMB also aims to modify physician-related barriers to minority enrollment in clinical trials, and BSBHS to improve patient adherence to treatment plans. Through didactic training, UMB aims to build a sustainable research program at BSBHS; through cultural sensitivity training, BSBHS expects to enhance the disparities program at UMB. The relative impact of physician and/or patient interventions for controlling hypertension and diabetes will be assessed. This will be a hypothesis-testing, prospective study, with an experimental 2 X 2 factorial design; it will be a four-arm randomized controlled trial. Outcomes will include adherence and improved knowledge/awareness of guidelines (of patients and their physicians), as well as patient clinical and quality of life measures. The study will be powered for the proportion of patients who attain the set goal. There will be a target enrollment of 800 patients (400 each for hypertension and diabetes), to afford 80% (up to 90%) power and allow for 25% attrition. Logistic regression will be used for the probability of reaching goal, multiple linear regression will be used for relative changes in mmHg (hypertension) and HbAlc (diabetes), and survival analysis will be used to model time to reach goal. Measurements will be taken of improved adherence of diabetes patients as a result of BSBHS actively identifying access barriers. Measurements will also be taken of changes in the willingness of patients to enroll in clinical trials as a result of physician-targeted education. The study seeks to demonstrate a best practice model, based on a collaborative partnership, and build a self-sustained research program at BSBHS and an enhanced cardiovascular disparities program at UMB. Community entities will have full access to resources at both institutions, which in turn will have access to invaluable input and support from community groups.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Hypertension
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 completionJan 2011
- Study completionJan 2011
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 Maryland, BaltimoreThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Elijah Saunders, MD, Principal investigator, University of Maryland, BaltimoreReed Winston, MD, Principal investigator, Bon Secours Hospital BaltimoreFadia T. Shaya, PhD, MPH, Principal investigator, Universitiy of Maryland BaltimoreWallace R. Johnson, MD, Principal investigator, Bon Secours Hospital Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101478
- Sponsor's protocol ID
- HP-00040555
- Other IDs
- U01HL079151
- Status last verified
- May 2021
- First submitted
- 10 Jan 2005
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership Programs to Reduce Cardiovascular Disparities - Baltimore Partnership
- ClinicalTrials.gov ID
- NCT00101478
- Acronym / sponsor ID
- HP-00040555
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (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 cardiovascular disease (CVD) outcomes in racial and ethnic minorities. Specifically, the study will aim to improve provider and patient approaches to treatment of hypertension and diabetes, respectively.
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. These are 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 minority healthcare serving systems (MSSs) that lack a strong research program and research-intensive medical centers (RIMCs) that have a track record of NIH-supported research and patient care. 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, thereby enhancing research opportunities and enriching 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 collaborative partnership between the Bon Secours Baltimore Health System (BSBHS) and the University of Maryland Baltimore (UMB) seeks to improve provider and patient approaches to treatment of hypertension and diabetes, respectively. UMB also aims to modify physician-related barriers to minority enrollment in clinical trials, and BSBHS to improve patient adherence to treatment plans. Through didactic training, UMB aims to build a sustainable research program at BSBHS; through cultural sensitivity training, BSBHS expects to enhance the disparities program at UMB. The relative impact of physician and/or patient interventions for controlling hypertension and diabetes will be assessed. This will be a hypothesis-testing, prospective study, with an experimental 2 X 2 factorial design; it will be a four-arm randomized controlled trial. Outcomes will include adherence and improved knowledge/awareness of guidelines (of patients and their physicians), as well as patient clinical and quality of life measures. The study will be powered for the proportion of patients who attain the set goal. There will be a target enrollment of 800 patients (400 each for hypertension and diabetes), to afford 80% (up to 90%) power and allow for 25% attrition. Logistic regression will be used for the probability of reaching goal, multiple linear regression will be used for relative changes in mmHg (hypertension) and HbAlc (diabetes), and survival analysis will be used to model time to reach goal. Measurements will be taken of improved adherence of diabetes patients as a result of BSBHS actively identifying access barriers. Measurements will also be taken of changes in the willingness of patients to enroll in clinical trials as a result of physician-targeted education. The study seeks to demonstrate a best practice model, based on a collaborative partnership, and build a self-sustained research program at BSBHS and an enhanced cardiovascular disparities program at UMB. Community entities will have full access to resources at both institutions, which in turn will have access to invaluable input and support from community groups.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study groups will be selected from primary and family health clinics, community, and patients of physicians participating in the study.
Key inclusion criteria (1 listed)
- Uncontrolled hypertension or diabetes
Key exclusion criteria (3 listed)
- Medical condition that would prevent treatment for hypertension at the University of Maryland
- Medical condition that would prevent treatment for diabetes at Bon Secours
- Uninsured
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 11 May 2021.
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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.
Elijah Saunders, MD principal investigator
University of Maryland, Baltimore
Reed Winston, MD principal investigator
Bon Secours Hospital Baltimore
Fadia T. Shaya, PhD, MPH principal investigator
Universitiy of Maryland Baltimore
2 sites 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 Maryland, Baltimore at 2 sites 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?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 11 May 2021.