Gbenga Ogedegbe1, Jonathan N Tobin2, Senaida Fernandez2, Andrea Cassells2, Marleny Diaz-Gloster2, Chamanara Khalida2, Thomas Pickering2, Joseph E Schwartz2. 1. From the Division of Health and Behavior and Center for Healthful Behavior Change, Department of Population Health, New York University Langone Medical Center, New York, NY (G.O., S.F.); Clinical Directors Network, New York, NY (J.N.T., A.C., M.D.-G., C.K.); Department of Epidemiology and Population Health, Albert Einstein College of Medicine of Yeshiva University, Bronx, NY (J.N.T.); Center for Clinical and Translational Science, Rockefeller University, New York, NY (J.N.T.); Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY (T.P., J.E.S.); Department of Psychiatry and Behavioral Science, Stony Brook University, Stony Brook, NY (J.E.S.). olugbenga.ogedegbe@nyumc.org. 2. From the Division of Health and Behavior and Center for Healthful Behavior Change, Department of Population Health, New York University Langone Medical Center, New York, NY (G.O., S.F.); Clinical Directors Network, New York, NY (J.N.T., A.C., M.D.-G., C.K.); Department of Epidemiology and Population Health, Albert Einstein College of Medicine of Yeshiva University, Bronx, NY (J.N.T.); Center for Clinical and Translational Science, Rockefeller University, New York, NY (J.N.T.); Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY (T.P., J.E.S.); Department of Psychiatry and Behavioral Science, Stony Brook University, Stony Brook, NY (J.E.S.).
Abstract
BACKGROUND: Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. METHODS AND RESULTS:Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). CONCLUSIONS: A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00233220.
RCT Entities:
BACKGROUND: Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. METHODS AND RESULTS: Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). CONCLUSIONS: A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00233220.
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