BACKGROUND: Only 31% of Americans with hypertension have their blood pressure (BP) under effective control. We describe a study that tests 3 different interventions in a randomized controlled trial using home BP telemedicine monitoring. METHODS: A sample of hypertensive patients with poor BP control at baseline (N = 600) are randomized to 1 of 4 arms: (1) control group--a group of hypertensive patients who receive usual care; (2) nurse-administered tailored behavioral intervention; (3) nurse-administered medication management according to a hypertension decision support system; (4) combination of the 2 interventions. The interventions are triggered based on home BP values transmitted via telemonitoring devices over standard telephone lines. The tailored behavioral intervention involves promoting adherence with medication and health behaviors. Patients randomized to the medication management or the combined arm have their hypertension regimen changed by the study team using a validated hypertension decision support system based on evidence-based hypertension treatment guidelines and individualized to patients' comorbid illnesses. The primary outcome is BP control: < or = 140/90 mm Hg (nondiabetic) and < or = 130/80 mm Hg (diabetics) measured at 6-month intervals over 18 months (4 total measurements). CONCLUSIONS: Given the increasing prevalence of hypertension and our inability to achieve adequate BP control using traditional models of care, testing novel interventions in patients' homes may improve access, quality, and outcomes.
RCT Entities:
BACKGROUND: Only 31% of Americans with hypertension have their blood pressure (BP) under effective control. We describe a study that tests 3 different interventions in a randomized controlled trial using home BP telemedicine monitoring. METHODS: A sample of hypertensivepatients with poor BP control at baseline (N = 600) are randomized to 1 of 4 arms: (1) control group--a group of hypertensivepatients who receive usual care; (2) nurse-administered tailored behavioral intervention; (3) nurse-administered medication management according to a hypertension decision support system; (4) combination of the 2 interventions. The interventions are triggered based on home BP values transmitted via telemonitoring devices over standard telephone lines. The tailored behavioral intervention involves promoting adherence with medication and health behaviors. Patients randomized to the medication management or the combined arm have their hypertension regimen changed by the study team using a validated hypertension decision support system based on evidence-based hypertension treatment guidelines and individualized to patients' comorbid illnesses. The primary outcome is BP control: < or = 140/90 mm Hg (nondiabetic) and < or = 130/80 mm Hg (diabetics) measured at 6-month intervals over 18 months (4 total measurements). CONCLUSIONS: Given the increasing prevalence of hypertension and our inability to achieve adequate BP control using traditional models of care, testing novel interventions in patients' homes may improve access, quality, and outcomes.
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