Community Partnership to Examine Racial and Ethnic Differences in Health Care for Hypertension and Diabetes (CHAMPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379652
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : May 20, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Harvard Medical School

Brief Summary:
Hypertension and diabetes are among the most common chronic diseases in the United States. Racial and ethnic minority groups are more at risk for these diseases than the Caucasian population. This study will attempt to identify factors that contribute to racial and ethnic differences in hypertension and diabetes care among minority patients of community health centers (CHCs). This information will be used to design and implement programs to improve quality of care in these communities.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitis Behavioral: Medical Practice Improvement Behavioral: Patient Education and Support Other: Combination Intervention to Include Medical Practice Improvement and Patient Education and Support Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1204 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community, Health Center, and Academic Medicine Partnership Project (CHAMPP)
Study Start Date : October 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
Patient-based intervention
Behavioral: Patient Education and Support
The details for the patient education and support intervention will be decided at a later date.

Active Comparator: B
Health center-based intervention
Behavioral: Medical Practice Improvement
The details for the medical practice improvement intervention will be decided at a later date.

Active Comparator: C
Combination of patient and health center-based intervention
Other: Combination Intervention to Include Medical Practice Improvement and Patient Education and Support
The details for this combination intervention will be decided at a later date.

No Intervention: D
Control group: Neither patient-based nor center-based intervention

Primary Outcome Measures :
  1. Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c [ Time Frame: Measured from June to August 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379652

United States, Massachusetts
Harvard Medical School
Boston, Massachusetts, United States, 02115
Center for Community Health Education, Research, and Service
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Harvard Medical School
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: LeRoi S. Hicks, MD, MPH Harvard Medical School
Study Director: Thomas Keegan, PhD Harvard Medical School

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Harvard Medical School Identifier: NCT00379652     History of Changes
Other Study ID Numbers: 410
R21HL083859-01 ( U.S. NIH Grant/Contract )
1R21HL083859-01 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: August 2009

Keywords provided by Harvard Medical School:
Community Health Centers
Blood Pressure, High

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases