Blood Pressure Control in African Americans

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gbenga Ogedegbe, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00233220
First received: October 3, 2005
Last updated: February 12, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

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 ]

Enrollment: 1039
Study Start Date: September 2004
Study Completion Date: March 2010
Primary Completion Date: March 2010 (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
Criteria

Inclusion Criteria:

  • Uncontrolled Hypertension
  • African American
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233220

Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Gbenga G Ogedegbe, MD NYU School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gbenga Ogedegbe, Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00233220     History of Changes
Other Study ID Numbers: 322, R01HL078566, R01 HL78566
Study First Received: October 3, 2005
Last Updated: February 12, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014