Blood Pressure Control in African Americans
Recruitment status was Recruiting
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Purpose
The purpose of this study is to test the effectiveness of a multi-component evidence-based intervention that targets both patients and physicians, in improving BP control rates in patients followed in 30 Community/Migrant Health Centers (C/MHCs).
| Condition | Intervention |
|---|---|
|
Cardiovascular Diseases Hypertension |
Behavioral: Multicomponent, multi-level intervention targeted at physicians and patients Behavioral: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-Site Randomized Controlled Trial for Blood Pressure Control in Hypertensive African Americans |
- Control BP [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Change in systolic BP and diastolic BP [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Maintenance of the intervention effects [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Cost effectiveness of the intervention [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 990 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients and doctors will take part in a multicomponent, multi-level intervention.
|
Behavioral: Multicomponent, multi-level intervention targeted at physicians and patients
The patient intervention will include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial.
|
|
Active Comparator: 2
Patients will receive usual care.
|
Behavioral: Usual Care
Patients will receive usual care.
|
Detailed Description:
BACKGROUND:
African Americans (AA) have the highest prevalence of hypertension (HTN) in the U.S., with a resultant greater HTN-related mortality compared to whites. Barriers to BP Control in AA exist at 3 levels of care: the patient, the physician, and the healthcare system. Using the Chronic Care Model as a framework, the investigators seek to test the effect on BP control of a multicomponent, multi-level intervention targeted at physicians and patients.
DESIGN NARRATIVE:
Using the Chronic Care Model as a framework, the investigators seek to test the effect on BP control of a multicomponent, multi-level intervention targeted at physicians and patients. They will conduct a clustered randomized controlled trial in which 30 C/MHCs will be randomized to either the intervention or usual care. A total of 990 patients with uncontrolled HTN (BP greater than 140/90 mm Hg) will be enrolled for this trial. Components of the patient intervention include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial. Patients and physicians at the usual care C/MHCs will receive NHLBI patient education materials and print versions of JNC-7 guidelines respectively.
The primary outcome is the proportion of patients with adequate BP control at 12 months in each condition as defined by JNC-7 criteria (BP less than 130/80 mm Hg for patients with diabetes or kidney disease; and BP less than 140/90 mm Hg for all other patients). The secondary outcomes are within-patient change in systolic BP and diastolic BP from baseline to 12 months; the maintenance of the intervention effects one year after trial; and the cost effectiveness of the intervention at 12 months. The long-term goal of this project is to refine the intervention as a result of the data obtained and to develop a standardized protocol that can be integrated into the usual care procedures of the C/MHCs. Thus, maximizing the likelihood that the intervention will be translated into practice, at each of the participating Community Health Centers.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Uncontrolled Hypertension
- African American
Contacts and Locations| United States, New York | |
| Columbia University Health Sciences | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Gbenga Godwin Ogedegbe, MD 212-342-4489 goo1@columbia.edu | |
| Principal Investigator: Gbenga G Ogedegbe, MD | |
| Principal Investigator: | Gbenga G Ogedegbe, MD | Columbia University Health Sciences |
More Information
No publications provided
| Responsible Party: | Gbenga Ogedegbe, M.D., MPH, M.S., Columbia University, College of Physicians and Surgeons |
| ClinicalTrials.gov Identifier: | NCT00233220 History of Changes |
| Other Study ID Numbers: | 322, R01 HL78566 |
| Study First Received: | October 3, 2005 |
| Last Updated: | April 14, 2009 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertension Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013