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

This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2008

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00379652
  Purpose

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

MedlinePlus related topics:   Diabetes    High Blood Pressure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Health Services Research, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:   Community, Health Center, and Academic Medicine Partnership Project (CHAMPP)

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 2007
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator
Patient-based intervention
Behavioral: Patient Education and Support
The details for the patient education and support intervention will be decided at a later date.
B: Active Comparator
Health center-based intervention
Behavioral: Medical Practice Improvement
The details for the medical practice improvement intervention will be decided at a later date.
C: Active Comparator
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.
D: No Intervention
Control group

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379652

Contacts
Contact: Thomas Keegan, PhD     617-432-4335     keegan@hcp.med.harvard.edu    

Locations
United States, Massachusetts
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            
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            

Sponsors and Collaborators

Investigators
Principal Investigator:     LeRoi S. Hicks, MD, MPH     Harvard University    
Study Director:     Thomas Keegan, PhD     Harvard University    
  More Information


Responsible Party:   Harvard Medical School ( LeRoi S. Hicks, MD, MPH )
Study ID Numbers:   410, 1 R21 HL083859-01
First Received:   September 20, 2006
Last Updated:   July 28, 2008
ClinicalTrials.gov Identifier:   NCT00379652
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Metabolic Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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