Study Overview
Objective. To examine the effect of self-monitoring of blood pressure and self-titration of antihypertensive medications among hypertensive patients with cardiovascular disease, diabetes, or chronic kidney disease.
Design. Unblinded randomized controlled trial.
Setting and participants. The study was conducted in central and east England. Patients with poorly controlled blood pressure with a last recorded systolic blood pressure of at least 145 mm Hg at 59 UK primary care practices were invited to participate. Patients had to be at least 35 years old and have at least 1 of the following comorbidities: transient ischemic attack or stroke, stage 3 chronic kidney disease, or history of coronary artery bypass graft surgery, myocardial infarction, or angina. Patients were excluded if they could not self-monitor blood pressure, had dementia or failed a cognitive screen using the short-orientation memory concentration test, had postural hypotension, took more than 3 antihypertensive medications, had an acute cardiovascular event within the previous 3 months, were receiving care from a specialist for their hypertension, were pregnant, or had a terminal disease. Participants were randomized to the self-management intervention or usual care.
Intervention. Patients in the self-management group were asked to monitor their blood pressure using an automated blood pressure monitor and to titrate their blood pressure medications using an individualized 3-step plan devised by the patient with their family physician. They were trained to do these tasks in 2- or 3-hour sessions. Patients were instructed to take their blood pressure twice each morning for the first week of each month; if 4 or more blood pressure readings during the measurement week for 2 consecutive months were higher than the target blood pressure, patients were to follow their individualized plan to change their medications. The target blood pressure was 120/75 mm Hg, following British guidelines for patients with stroke, diabetes, chronic kidney disease, or coronary heart disease. If patients exhausted all 3 steps for medication titration, they were to return to their family physician for additional instructions. Patients in the usual care group had a routine blood pressure check and medication review appointment with their family physician, which was followed by follow-up care at the discretion of the family physician for blood pressure measurement, blood pressure targets, or adjustment of medication.
Main outcome measure . The primary outcome was systolic blood pressure at 12 months. The difference in outcomes between the intervention and usual care groups was examined while accounting for baseline blood pressure and other clinical factors. 6 blood pressures were taken at 1-minute intervals after an initial 5 minutes of rest. Blood pressure was taken by an electronic automated blood pressure machine. The mean of the second and third readings were used as primary outcome. Outcome assessor was not blinded to group assignment. The primary analysis included all cases with complete data, and a sensitivity analysis with multiple imputations was also performed. Preplanned subgroup analyses included older vs. younger age-groups, men vs. women, and other risk groups.
Main results. Among 10,764 patients assessed for eligibility, 3353 were excluded as they were considered by their family physician to be housebound, have a terminal illness, or not be a suitable candidate. Among the 7411 invited to participate, 4207 did not respond to the invitation and 2003 declined participation (with a third who did not want to alter their own medications, and a third who did not want to measure their own blood pressure). Among the 1201 who attended the baseline clinic, 138 withdrew their consent and 508 were deemed ineligible. A total of 555 were randomized, and 220 in the intervention group and 230 in the control group completed the study and provided outcome data (81%). Patients in the self-management group had a 9.2 mm Hg–lower systolic blood pressure at 12 months (95% CI, 5.7–12.7) compared with the usual care group. The self-management group also had a larger increase in the intake of antihypertensive drugs compared with controls, with an increase in both doses and number of medications. Although adverse symptoms were common in both groups, there were no significant differences in adverse symptoms between groups.
Conclusions. Self-management of hypertension among patients with stroke, cardiovascular disease, and other high-risk conditions is safe and effective in achieving better blood pressure control.
Commentary
Hypertension is a major public health problem. Significant resources have been devoted to advance hypertension management through research, practice improvements, and guideline developments; however, blood pressure control among those with hypertension in the United States remains suboptimal—with only about half achieving adequate control [1].
Advances in technology have made home blood pressure monitoring possible. It offers several advantages to traditional office-based blood pressure management [2], and several studies have shown home blood pressure telemonitoring and team care can achieve better outcomes than office-based management [3]. A significant contribution of the current study is that it demonstrated that the self-management approach is both safe and effective even in high-risk patients, who are perhaps the most likely to have adverse events from treatment but also the most likely to derive benefit from adequate treatment of hypertension.
Although the self-management approach has promise, it also has potential drawbacks. Specifically, as demonstrated by the low enrollment rate in this study, this intervention may not be suitable for all patients. About two-thirds of those who responded to the initial enrollment attempt ultimately declined participation because they did not want to modify their own medications or did not want to perform the tasks of home blood pressure monitoring. This perhaps is a realistic assessment of who may ultimately benefit from this approach—patients who wish to have an active role in managing their medical problems and have the ability to do so. For the clinician, it is important to identify patients who are able to manage the complex task of adjusting their medication regimen; otherwise, the potential for harm may be magnified.
Engaging patients in the management of their chronic disease is a growing trend in chronic disease management. Bringing management of hypertension to patients’ homes, as the accompanying editorial in the issue pointed out, reflects patient-centeredness at its best and represents an important step toward the adaptation of treatment for patients who want to actively take part in their own care [2].
Applications for Clinical Practice
Self-management of blood pressure in patients at high risk of cardiovascular disease appears feasible. As the editorialists note, this study is an important step toward adaptation of treatment for patients who want to actively take part in their own risk-factor control [2]. More research is needed to study the effects of self-titration on long-term outcomes and to identify the appropriate protocols that can be applied by clinicians in the community, both for patient selection and education and medication adjustment.
—William Hung, MD, MPH