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Hypertension affects more than 73 million people in the United States—approximately 1 in 3 of the adult population. It is a leading cause of morbidity and mortality worldwide. Numerous clinical trials have shown that controlling blood pressure (BP) in patients with hypertension significantly reduces the risk of cardiovascular (CV) events such as stroke, myocardial infarction, and heart failure. Despite the availability of effective and newer antihypertensive therapies, BP continues to be inadequately controlled in clinical practice. In fact, recent data from the National Health and Nutrition Examination Survey (NHANES) found that BP control was achieved in only 50.1% of patients with hypertension. Therefore, a potentially important role for new approaches to improve BP control exists, especially in primary care, where most of the management of hypertension occurs. One such approach is to involve patients in their own care, engaging patients in the self-monitoring and self-management of their own BP. This is similar to models currently used in the management of diabetes, asthma, and anticoagulation control but has only been tested in two studies that have assessed self-monitoring of BP in combination with self-titration of antihypertensive drugs as a strategy to improve BP control in those with hypertension.

The Telemonitoring and Self-Management of Hypertension Trial (TASMINH2) was a prospective, randomized, open trial in the United Kingdom involving 24 general practices (8–56 patients per practice) between March 2007 and May 2008. To be enrolled, patients had to be aged 35 to 85, treated with 1 or 2 antihypertensive drugs, have a BP >140/90 mm Hg, and be willing to self-monitor their BP using a telemonitoring system, where home BP readings were transmitted to a health care professional to make sure that very high or low readings were not being ignored by the patient. In addition, patients were to self-titrate their own medication based on a predefined and agreed upon schedule. Exclusion criteria included a BP >200/100 mm Hg, a postural drop in systolic BP >20 mm Hg, terminal disease, dementia, or a spouse already in the study. Assigned to the intervention or control group in a 1:1 ratio based on a computer-generated allocation sequence, open randomization was stratified by the individual general practice with minimization for sex, baseline systolic BP (≤150 mm Hg vs >150 mm Hg), and the presence or absence of diabetes or chronic kidney disease (CKD). Outcome measurement was not blinded but used the automatic mode of the sphygmomanometer to measure BP without the need for intervention by the investigator other than to activate the cuff device. All participants received information from the British Hypertension Society on lifestyle interventions to reduce BP. All participating family physicians were given a copy of the current National Institute for Health and Clinical Excellence (NICE) guidelines. Patients allocated to the control group received usual care for hypertension and were asked to attend one review session with their family physician who remained responsible for all of their care. Patients assigned to the intervention group were invited to 2 training sessions conducted by the research team where they were trained to take their own BP with an OMRON 705IT automated sphygmomanometer (Omron Healthcare Europe, Hoofddorp, The Netherlands) and to transmit their BP readings to the research team by means of an automated modem device (i-modem; Netmedical, DeMeern, The Netherlands).

Two self-measurements of BP were made each morning within a 5-minute interval with the second reading acted upon during the first week of each month. A month of readings was deemed to be “above target” if the readings on 4 or more days during the week were above target. If patients had 2 consecutive months of BP readings above target, they would contact their physician for a prescription allowing them to adjust their medicines based on the self-titration schedule. Self-titration schedules were agreed upon between participants and their family doctor and included the option to monitor renal function when using an angiotensin-converting enzyme inhibitor. Monthly summaries of each patient’s BP readings were sent to their family doctor. The targeted BP from home readings was based on the NICE guidelines, which were adjusted down by 10/5 mm Hg (130/85 mm Hg for patients with diabetes or CKD) in accordance with the recommendations from the British Hypertension Society. A telemonitored BP >200/100 mm Hg or systolic BP <100 mm Hg triggered a BP check by the practice, which made sure that the patient had followed their safety advice.

The primary outcome for the study was the change in mean systolic BP from the day of entry to each follow-up visit at 6 and 12 months and was adjusted for the following covariates: baseline BP >150 mm Hg, sex, and diabetes or CKD. Of the 1650 patients eligible for enrollment, 91% (480 of the 527 patients randomly assigned) attended follow-up visits at 6 and 12 months, for which complete data were available for the primary outcome. Mean office BP at baseline was 152/85 mm Hg in both groups. After 6 months, mean office BP in the usual care and intervention groups was 143/80 mm Hg and 139/80 mm Hg, respectively. Mean systolic BP decreased by 12.9 mm Hg (95% confidence interval [CI], 10.4–15.5) from baseline to 6 months in the self-management group and by 9.2 mm Hg (95% CI, 6.7–11.8) in the control group (difference between groups, 3.7 mm Hg; 95% CI, 0.8–6.6; P=.013). Mean office BP after 12 months was 140/80 mm Hg and 135/77 mm Hg in the usual care and intervention groups, respectively. From baseline to 12 months, systolic BP decreased by 17.6 mm Hg (95% CI, 14.9–20.3) in the self-management group and by 12.2 mm Hg (95% CI, 9.5–14.9) in the control group (difference between groups, 5.4 mm Hg; 95% CI, 2.4–8.5; P=.004. There was no significant difference between the intervention and control groups in diastolic BP at 6 months (1.3 mm Hg; P=.108), but it was significant at 12 months (2.7 mm Hg; P=.001). Of the 210 patients (80%) who self-managed their hypertension for the full 12 months of the study, 148 (70%) made at least one medication change. Patients in the intervention group were prescribed 0.32 (0.21–0.43) additional antihypertensive drugs compared with the control group at 6 months (P=.001) and 0.46 (0.34–0.58) additional antihypertensive drugs at 12 months (P=.001). More participants in the intervention group required ≥3 antihypertensive agents to control their BP, including more thiazide diuretic and calcium channel blocker use, and fewer required a single agent. Side effects were measured by use of standard questionnaires. Leg swelling was more frequent in the self-management group (74 patients [32%]; control group, 55 patients [22%]; P=.022) with no other differences noted between groups for any of the other side effects monitored. While the quality of life improved in the self-management group over time, the difference between groups was not significant. After 12 months in the trial, patients were asked to rank their preferred method of BP monitoring by choosing between measurement by a doctor, nurse, self-monitoring in the practice, or self-monitoring at home. A total of 71% of the intervention group ranked self-monitoring at home as their preferred method for BP monitoring compared with 43% of the control group (P<.001).

Self-management of hypertension using a simple drug titration plan in combination with telemonitoring of BP resulted in significant reductions in systolic BP at 6 and 12 months compared with usual care. The self-addition of medications when patients were not at goal may have overcome any therapeutic inertia sometimes associated with physician management. Self-management represents an important addition to the control of hypertension in primary care.—McManus RJ, Mant J, Bray EP, et al. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomized controlled trial. Lancet. 2010;376:163. (http://dx.doi.org/10.1016/S0140-6736(10)60964-6)

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A number of potential reasons for suboptimal control of BP have been identified in the literature. These include, but are not limited to, nonadherence to antihypertensive therapy, which has been implicated in up to 50% of treatment failures, financial constraints, and lack of access to health care. In addition to these patient-related factors, therapeutic inertia has been a concern. Defined as a failure of the practitioner to begin new medication or increase the dose of existing medications when treatment goals are not met, physicians often fail to act to improve BP control despite recognition of the problem.

In an effort to overcome therapeutic inertia, and have patients more involved in their own care, TASMINH2 advances our knowledge on the importance of self-titration and self-management in the treatment and control of hypertension. It found that self-management of hypertension, consisting of regular self-measurements of BP, and a simple plan that allowed self-titration of BP medications, was more effective in lowering systolic BP at the end of 6 months and 1 year compared with usual care; the absolute reduction in BP being 3.7 mm Hg at 6 months and 5.4 mm Hg at 1 year. Taking only 2 self-measurements of BP every morning for 1 week each month, those with average readings on ≥4 days of the week above the target BP of 130/85 mm Hg and 130/75 mm Hg in those with diabetes or CKD for 2 consecutive months were required to adjust their antihypertensive medications according to a prespecified titration schedule. Of note, they contacted their family physician or research team only when the telemonitored values were above the safety limits of >200/100 mm Hg or <100 mm Hg.

The improvement in BP control most likely occurred because of the increased adjustment and increased use of antihypertensive medications, particularly thiazide diuretic and calcium channel blocker therapy, seen in the group self-managing their hypertension. It is difficult, however, to separate the contribution of self-management from the role that a lower BP goal or the role that telemonitoring played. Telemonitoring was used to check that participants had adhered to safety advice, but the main thrust of this study was self-management, with patients adjusting their medication regimen based on their home BP results, unlike in other trials that prompted physicians or nurses to make the medication changes. When the prespecified BP thresholds for additional antihypertensive therapy were reached in the self-management group, a prescription would be called in for the patient by the research team. Of note, the beneficial effects on BP at 12 months were not associated with any increase in anxiety or differences in quality of life even though the self-management group required more antihypertensive therapy. Except for lower extremity edema, probably the result of the increased calcium channel blocker use in the self-management group, side effects were similar between groups. By the end of the trial, patients who self-managed their hypertension rated self-monitoring of BP more preferable to measurement by a doctor or nurse or self-monitoring in the practice.

The study has several limitations, however. First, while follow-up was achieved in >90% of the patients in both groups, it is possible that those lost to follow-up had worse BP control than those who attended study visits. In fact, patients in the intervention group were less likely to attend follow-up, possibly reflecting the additional burden imposed by self-management. Second, the study took place in England. No blacks, Latinos, or other minority groups were studied and socially challenged patients were under-represented, questioning how generalizable the study findings would be in the United States. In addition, the study did not allow patients who required ≥3 antihypertensive agents to be enrolled, excluding all those with resistant hypertension.

While understanding the cost-effectiveness of the intervention is important and will be separately reported, the present study could affect how we treat patients with uncomplicated hypertension in the future. Before doing so, however, several questions need to be asked. Who is the best group of patients with hypertension to be treated with self-management: those with newly diagnosed disease, those requiring ≤2 antihypertensive medications? What is the optimum self-titration schedule, and after how many self-measurements should a patient be considered uncontrolled and self-manage their antihypertensive medications? Will physicians be paid for overseeing home BP management that does not require face-to-face interaction, the model that presently dictates reimbursement?

The present study suggests that out-of-office self-monitoring and self-management of BP in patients with hypertension can be accomplished in a primary care setting if there is a defined patient treatment algorithm, a telemonitoring BP feedback system, and patients and physicians involved in a coordinated health care management system. Current studies in the United States are ongoing and will determine whether the present findings from England can be exported to patients we are more likely to see in the United States, those from low-income or low-literacy communities who may be less able to participate and replicate the findings from the present study.