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Blood Pressure Control in African Americans
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), February 2008
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00233220
  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

MedlinePlus related topics: High Blood Pressure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: Multi-Site Randomized Controlled Trial for Blood Pressure Control in Hypertensive African Americans

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Control BP [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
1: Experimental
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.
2: No Intervention
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
Criteria

Inclusion Criteria:

  • Uncontrolled Hypertension
  • African American
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233220

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            
Sponsors and Collaborators
Investigators
Principal Investigator: Gbenga G Ogedegbe, MD Columbia University Health Sciences
  More Information

Responsible Party: Columbia University, College of Physicians and Surgeons ( Gbenga Ogedegbe, M.D., MPH, M.S. )
Study ID Numbers: 322, R01 HL78566
Study First Received: October 3, 2005
Last Updated: February 1, 2008
ClinicalTrials.gov Identifier: NCT00233220  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Vascular Diseases
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009