- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00379652
Community Partnership to Examine Racial and Ethnic Differences in Health Care for Hypertension and Diabetes (CHAMPP)
Community, Health Center, and Academic Medicine Partnership Project (CHAMPP)
Study Overview
Status
Conditions
Detailed Description
Hypertension and diabetes are the primary contributors to today's high rates of heart disease and stroke, which are the first and third leading causes of death in the United States, respectively. African Americans and Hispanics have a higher risk of developing hypertension and diabetes than do Caucasians. They are also less likely to know that they have high blood pressure, are more prone to organ damage, and are more likely to die as a result of these chronic conditions. A significant number of African Americans and Hispanics are uninsured and receive care through publicly supported CHCs. It is important to identify factors that contribute to healthcare differences among the lower income, uninsured, and minority populations that are typically served by CHCs. In this study, a collaborative partnership will be developed between CHCs, health service research organizations, and academic researchers. The goal of the study is to examine the barriers that minority CHC patients face in receiving appropriate hypertension and diabetes care.
This study will develop a collaborative partnership between various health organizations and seven CHCs located in Boston neighborhoods that have a large percentage of African American and Hispanic residents. Researchers will conduct focus groups with CHC patients who are receiving care for hypertension or diabetes. CHC staff members will be interviewed to collect information regarding the relationship between CHC organizational structure and disparities in heart disease risk factors among minority patients with hypertension or diabetes. Researchers will then develop, implement, and evaluate a patient- and CHC-focused intervention aimed at reducing the cardiovascular risks of minority patients at four CHCs in Boston.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Harvard Medical School
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Boston, Massachusetts, United States, 02118
- Center for Community Health Education, Research, and Service
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetes
- Hypertension, as diagnosed by the average of two or more blood pressure measurements taken during two or more study visits following an initial screening
- Race is 'Black' or ethnicity is 'Hispanic'
- Patient at participating Community Health Center
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A
Patient-based intervention
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The details for the patient education and support intervention will be decided at a later date.
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Active Comparator: B
Health center-based intervention
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The details for the medical practice improvement intervention will be decided at a later date.
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Active Comparator: C
Combination of patient and health center-based intervention
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The details for this combination intervention will be decided at a later date.
|
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No Intervention: D
Control group: Neither patient-based nor center-based intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c
Time Frame: Measured from June to August 2008
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Measured from June to August 2008
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: LeRoi S. Hicks, MD, MPH, Harvard Medical School (HMS and HSDM)
- Study Director: Thomas Keegan, PhD, Harvard Medical School (HMS and HSDM)
Publications and helpful links
General Publications
- Ndumele CD, Ableman G, Russell BE, Gurrola E, Hicks LS. Publication of recruitment methods in focus group research of minority populations with chronic disease: a systematic review. J Health Care Poor Underserved. 2011 Feb;22(1):5-23. doi: 10.1353/hpu.2011.0031.
- Russell BE, Gurrola E, Ndumele CD, Landon BE, O'Malley JA, Keegan T, Ayanian JZ, Hicks LS; Community Health and Academic Medicine Partnership Project. Perspectives of non-Hispanic Black and Latino patients in Boston's urban community health centers on their experiences with diabetes and hypertension. J Gen Intern Med. 2010 Jun;25(6):504-9. doi: 10.1007/s11606-010-1278-0. Epub 2010 Feb 24.
- Ndumele CD, Russell BE, Ayanian JZ, Landon BE, Keegan T, O'Malley AJ, Hicks LS. Strategies to improve chronic disease management in seven metro Boston community health centers. Prog Community Health Partnersh. 2009 Fall;3(3):203-11. doi: 10.1353/cpr.0.0080.
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
- 410
- R21HL083859-01 (U.S. NIH Grant/Contract)
- 1R21HL083859-01 (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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