Community Partnership to Examine Racial and Ethnic Differences in Health Care for Hypertension and Diabetes (CHAMPP)
Primary Purpose
Hypertension, Diabetes Mellitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Practice Improvement
Patient Education and Support
Combination Intervention to Include Medical Practice Improvement and Patient Education and Support
Sponsored by

About this trial
This is an interventional health services research trial for Hypertension focused on measuring Community Health Centers, Diabetes, Blood Pressure, High
Eligibility 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
Sites / Locations
- Harvard Medical School
- Center for Community Health Education, Research, and Service
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
A
B
C
D
Arm Description
Patient-based intervention
Health center-based intervention
Combination of patient and health center-based intervention
Control group: Neither patient-based nor center-based intervention
Outcomes
Primary Outcome Measures
Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c
Secondary Outcome Measures
Full Information
NCT ID
NCT00379652
First Posted
September 20, 2006
Last Updated
January 9, 2023
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00379652
Brief Title
Community Partnership to Examine Racial and Ethnic Differences in Health Care for Hypertension and Diabetes
Acronym
CHAMPP
Official Title
Community, Health Center, and Academic Medicine Partnership Project (CHAMPP)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitis
Keywords
Community Health Centers, Diabetes, Blood Pressure, High
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Patient-based intervention
Arm Title
B
Arm Type
Active Comparator
Arm Description
Health center-based intervention
Arm Title
C
Arm Type
Active Comparator
Arm Description
Combination of patient and health center-based intervention
Arm Title
D
Arm Type
No Intervention
Arm Description
Control group: Neither patient-based nor center-based intervention
Intervention Type
Behavioral
Intervention Name(s)
Medical Practice Improvement
Intervention Description
The details for the medical practice improvement intervention will be decided at a later date.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education and Support
Intervention Description
The details for the patient education and support intervention will be decided at a later date.
Intervention Type
Other
Intervention Name(s)
Combination Intervention to Include Medical Practice Improvement and Patient Education and Support
Intervention Description
The details for this combination intervention will be decided at a later date.
Primary Outcome Measure Information:
Title
Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c
Time Frame
Measured from June to August 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LeRoi S. Hicks, MD, MPH
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Keegan, PhD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Study Director
Facility Information:
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Center for Community Health Education, Research, and Service
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21317503
Citation
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 Feb;22(1):5-23. doi: 10.1353/hpu.2011.0031.
Results Reference
derived
PubMed Identifier
20180156
Citation
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. doi: 10.1007/s11606-010-1278-0. Epub 2010 Feb 24.
Results Reference
derived
PubMed Identifier
19802379
Citation
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. doi: 10.1353/cpr.0.0080.
Results Reference
derived
Learn more about this trial
Community Partnership to Examine Racial and Ethnic Differences in Health Care for Hypertension and Diabetes
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