Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Not yet recruiting
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: September 20, 2006
Last updated: August 27, 2009
Last verified: August 2009

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 Intervention
Diabetes Mellitis
Behavioral: Medical Practice Improvement
Behavioral: Patient Education and Support
Other: Combination Intervention to Include Medical Practice Improvement and Patient Education and Support

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Community, Health Center, and Academic Medicine Partnership Project (CHAMPP)

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c [ Time Frame: Measured from June to August 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1204
Study Start Date: October 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00379652

Contact: Thomas Keegan, PhD 617-432-4335

United States, Massachusetts
Center for Community Health Education, Research, and Service Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Elmer Freeman, MSW         
Sub-Investigator: Beverley Russell, MSN, PhD         
Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02115
Sub-Investigator: John Z. Ayanian, MD         
Sub-Investigator: Bruce E. Landon, MD, MBA         
Sub-Investigator: James O'Malley, PhD         
Principal Investigator: LeRoi S. Hicks, MD, MPH         
Sponsors and Collaborators
Principal Investigator: LeRoi S. Hicks, MD, MPH Harvard Medical School
Study Director: Thomas Keegan, PhD Harvard Medical School
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: LeRoi S. Hicks, MD, MPH, Harvard Medical School Identifier: NCT00379652     History of Changes
Other Study ID Numbers: 410, 1 R21 HL083859-01
Study First Received: September 20, 2006
Last Updated: August 27, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Community Health Centers
Blood Pressure, High

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases processed this record on February 27, 2015