HypertensionCHAMPPNCT00379652
Community Partnership to Examine Racial and Ethnic Differences in Health Care for Hypertension and Diabetes
A study testing Medical Practice Improvement, Patient Education and Support and Combination Intervention to Include Medical Practice Improvement and Patient Education and Support in people with Hypertension and Diabetes Mellitis, run by Harvard Medical School (HMS and HSDM) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitis
- What is being tested?
- Medical Practice Improvement, Patient Education and Support and Combination Intervention to Include Medical Practice Improvement and Patient Education and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,204 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harvard Medical School
Boston, Massachusetts, 02115
Center for Community Health Education, Research, and Service
Boston, Massachusetts, 02118
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Diabetes Mellitis
- Being tested
- Medical Practice Improvement, Patient Education and Support, Combination Intervention to Include Medical Practice Improvement and Patient Education and Support
- Keywords
- Community Health Centers, Diabetes, Blood Pressure, High
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Practice ImprovementBehavioural
The details for the medical practice improvement intervention will be decided at a later date.
Patient Education and SupportBehavioural
The details for the patient education and support intervention will be decided at a later date.
Combination Intervention to Include Medical Practice Improvement and Patient Education and SupportOther
The details for this combination intervention will be decided at a later date.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patient-based intervention Receives: Behavioral: Patient Education and Support |
| B | Active comparator | Health center-based intervention Receives: Behavioral: Medical Practice Improvement |
| C | Active comparator | Combination of patient and health center-based intervention Receives: Other: Combination Intervention to Include Medical Practice Improvement and Patient Education and Support |
| D | No intervention | Control group: Neither patient-based nor center-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c
Measured: Measured from June to August 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- LeRoi S. Hicks, MD, MPH, Principal investigator, Harvard Medical School (HMS and HSDM)Thomas Keegan, PhD, Study director, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379652
- Sponsor's protocol ID
- 410
- Other IDs
- R21HL083859-01, 1R21HL083859-01
- Acronym
- CHAMPP
- Status last verified
- Jan 2023
- First submitted
- 20 Sep 2006
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21317503Russell 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.
PubMed 20180156Ndumele 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.
PubMed 19802379
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community, Health Center, and Academic Medicine Partnership Project (CHAMPP)
- ClinicalTrials.gov ID
- NCT00379652
- Acronym / sponsor ID
- CHAMPP / 410
- Conditions
- Hypertension, Diabetes Mellitis
- Keywords
- Community Health Centers, Diabetes, Blood Pressure, High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,204 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Patient Education and SupportPatient-based intervention |
| B | Active comparator | Behavioral: Medical Practice ImprovementHealth center-based intervention |
| C | Active comparator | Other: Combination Intervention to Include Medical Practice Improvement and Patient Education and SupportCombination of patient and health center-based intervention |
| D | No intervention | –Control group: Neither patient-based nor center-based intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Practice ImprovementThe details for the medical practice improvement intervention will be decided at a later date. | Behavioural | B |
| Patient Education and SupportThe details for the patient education and support intervention will be decided at a later date. | Behavioural | A |
| Combination Intervention to Include Medical Practice Improvement and Patient Education and SupportThe details for this combination intervention will be decided at a later date. | Other | C |
Primary outcome
Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c
Time frame: Measured from June to August 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 21317503Ndumele 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.
- Derived from this study: PubMed 20180156Russell 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.
- Derived from this study: PubMed 19802379Ndumele 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LeRoi S. Hicks, MD, MPH principal investigator
Harvard Medical School (HMS and HSDM)
Thomas Keegan, PhD study director
Harvard Medical School (HMS and HSDM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Practice Improvement, Patient Education and Support and Combination Intervention to Include Medical Practice Improvement and Patient Education and Support in people with Hypertension and Diabetes Mellitis, run by Harvard Medical School (HMS and HSDM) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c (time frame: Measured from June to August 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379652, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.