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

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00379652

First received: September 20, 2006

Last updated: August 27, 2009

Last verified: August 2009

History of Changes

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 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:

MedlinePlus related topics: Diabetes High Blood Pressure

U.S. FDA Resources

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.

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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 ClinicalTrials.gov Identifier (NCT Number):

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;22(1):5-23.

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. 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.

Responsible Party:	LeRoi S. Hicks, MD, MPH, Harvard Medical School
ClinicalTrials.gov 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
Diabetes
Blood Pressure, High

Additional relevant MeSH terms:

Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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