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Blood Pressure Control in African Americans

Multi-site Randomized Controlled Trial for Blood Pressure Control in Hypertensive African Americans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00233220
Enrollment
1039
Registered
2005-10-05
Start date
2004-09-30
Completion date
2010-03-31
Last updated
2014-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Hypertension

Brief summary

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).

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.

Interventions

BEHAVIORALMulticomponent, 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.

BEHAVIORALUsual Care

Patients will receive usual care.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Uncontrolled Hypertension * African American

Design outcomes

Primary

MeasureTime frame
Control BPMeasured at Year 1

Secondary

MeasureTime frame
Change in systolic BP and diastolic BPMeasured at Year 1
Maintenance of the intervention effectsMeasured at Year 1
Cost effectiveness of the interventionMeasured at Year 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026