IMPORTANCE: Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups. OBJECTIVE: To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease. DESIGN, SETTING, AND PATIENTS: A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013. INTERVENTIONS: Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80mmHg and the home measurement target was 120/75mmHg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary. MAIN OUTCOMES AND MEASURES: The primary outcomewas the difference in systolic blood pressure between intervention and control groups at the 12-month office visit. RESULTS: Primary outcome datawere available from 450 patients (81%). The mean baseline blood pressurewas 143.1/80.5mmHg in the intervention group and 143.6/79.5mmHg in the control group.After 12 months, the mean blood pressure had decreased to 128.2/73.8mmHg in the intervention group and to 137.8/76.3mmHg in the control group, a difference of 9.2mmHg (95%CI, 5.7-12.7) in systolic and 3.4mmHg (95%CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baselinewas 143.5/80.2mmHg in the intervention group vs 144.2/79.9mmHg in the control group, and at 12 months, the meanwas 128.6/73.6mmHg in the intervention group vs 138.2/76.4mmHg in the control group, with a difference of 8.8mmHg (95%CI, 4.9-12.7) for systolic and 3.1mmHg (95%CI,0.7-5.5) for diastolic blood pressure between groups. These resultswere comparable in all subgroups, without excessive adverse events. CONCLUSIONS AND RELEVANCE: Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN87171227 Copyright 2014 American Medical Association. All rights reserved.
JAMA - Journal of the American Medical Association
799 - 808