Randomized Controlled Trial of E-Counseling for Hypertension
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BACKGROUND: The efficacy of internet-based interventions to improve hypertension management is not established. We evaluated the therapeutic benefit of e-counseling by adapting best evidence guidelines for behavioral counseling. METHODS AND RESULTS: This multicenter double-blind randomized controlled trial included assessments at baseline, 4 months, and 12 months. Participants were 35 to 74 years of age and diagnosed with hypertension: systolic/diastolic blood pressure (BP) 130 to 180/85 to 110 mm Hg. BP was assessed by automated office measurement. E-Counseling used multimedia and interactive tools to increase motivation and skill for self-care (exercise, diet, medication adherence, and smoking cessation). Control used self-care education. Frequency of contact by our e-platform was equal for both trial arms. Primary end points were change at 4 and 12 months in systolic BP, diastolic BP, pulse pressure, total lipoprotein cholesterol, low-density lipoprotein cholesterol, total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio, non-high-density lipoprotein cholesterol, and Framingham 10-year cardiovascular risk index. Intention-to-treat analysis used generalized linear models adjusted for baseline measures, sex, and medications. Among 264 participants, mean age was 57.6 years (SE, 0.6), 58% were women, with 83% on antihypertensive medications. At 12 months, e-counseling versus control evoked greater reduction in systolic BP (-10.1 mm Hg [95% confidence interval (CI), -12.5, -7.6] versus -6.0 mm Hg [95% CI, -8.5, -3.5]; P=0.02); pulse pressure (-5.2 mm Hg [95% CI, -6.9, -3.5] versus -2.7 mm Hg [95% CI, -4.5, -0.9]; P=0.04), and Framingham risk index (-1.9% [95% CI, -3.3, -0.5] versus -0.02% [95% CI, -1.2, 1.7]; P=0.02), respectively. Among males in e-counseling versus control, 12-month end points included lower diastolic BP (P=0.01), non-high-density lipoprotein cholesterol (P=0.04), total lipoprotein cholesterol (P=0.03), and a trend for total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio (P=0.07). CONCLUSIONS: To our knowledge, this is the first double-blind randomized trial of e-counseling for hypertension. Added benefit for medical therapy was achieved by combining available technology with a clinically organized protocol of motivational and cognitive-behavioral counseling. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov; Unique identifier: NCT01541540.
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