Robert P Nolan1,2, Ross Feldman3, Martin Dawes4, Janusz Kaczorowski5, Hazel Lynn6, Susan I Barr4, Carolyn MacPhail7, Scott Thomas2, Jack Goodman2, Gunther Eysenbach8,2, Sam Liu9, Rika Tanaka10, Jelena Surikova10. 1. Peter Munk Cardiac Centre (R.P.N., R.T., J.S.) rnolan@uhnres.utoronto.ca. 2. University of Toronto, Ontario, Canada (R.P.N., S.T., J.G., G.E.). 3. St. Boniface Hospital, University of Manitoba, Winnipeg, Canada (R.F.). 4. University of British Columbia, Vancouver, Canada (M.D., S.I.B.). 5. Université de Montréal, Quebec, Canada (J.K.). 6. Grey Bruce Health Unit, Owen Sound, Ontario, Canada (H.L.). 7. Health PEI, Community Health, Charlottetown, Prince Edward Island, Canada (C.M.). 8. Global eHealth (G.E.), University Health Network, Toronto, Ontario, Canada. 9. University of Victoria, British Columbia, Canada (S.L.). 10. Peter Munk Cardiac Centre (R.P.N., R.T., J.S.).
Abstract
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.
RCT Entities:
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.
Authors: Fatimah Najihah Baderol Allam; Mohd Ramadan Ab Hamid; Siti Sabariah Buhari; Harrinni Md Noor Journal: J Med Internet Res Date: 2021-03-15 Impact factor: 5.428
Authors: Nicole L Guthrie; Mark A Berman; Katherine L Edwards; Kevin J Appelbaum; Sourav Dey; Jason Carpenter; David M Eisenberg; David L Katz Journal: JMIR Cardio Date: 2019-03-12