View Clinical Trial (Medical Research Study)
Multi-Site Randomized Controlled Trial for Blood Pressure Control in Hypertensive African Americans
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10032 |
| Conditions: |
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Cardiovascular Diseases - Hypertension |
| Purpose: |
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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).
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Uncontrolled Hypertension
- African American
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| NCT ID: |
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NCT00233220 |
| Primary Contact: |
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Principal Investigator
Gbenga G Ogedegbe, MD
Columbia University Health Sciences
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10032
United States
Gbenga Godwin Ogedegbe, MD
Phone: 212-342-4489
Email: goo1@columbia.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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