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

January 9, 2023 updated by: Harvard Medical School (HMS and HSDM)

Community, Health Center, and Academic Medicine Partnership Project (CHAMPP)

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.

Study Overview

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

Enrollment (Anticipated)

1204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard Medical School
      • Boston, Massachusetts, United States, 02118
        • Center for Community Health Education, Research, and Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
The details for the patient education and support intervention will be decided at a later date.
Active Comparator: B
Health center-based intervention
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
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

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
Measured from June to August 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimate)

September 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

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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