Abstract
BackgroundInadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, particularly of those at high risk of cardiovascular events. Preliminary evidence suggests that home blood pressure telemonitoring (HBPT) might help increasing the chance of achieving blood pressure targets and improve patient’s therapeutic adherence. However, all these potential advantages of HBPT have not yet been fully investigated.Methods/designThe purpose of this open label, parallel group, randomized, controlled study is to assess whether, in patients with high cardiovascular risk (treated or untreated essential arterial hypertension - both in the office and in ambulatory conditions over 24 h - and metabolic syndrome), long-term (48 weeks) blood pressure control is more effective when based on HBPT and on the feedback to patients by their doctor between visits, or when based exclusively on blood pressure determination during quarterly office visits (conventional management (CM)). A total of 252 patients will be enrolled and randomized to usual care (n=84) or HBPT (n=168). The primary study endpoint will be the rate of subjects achieving normal daytime ambulatory blood pressure targets (<135/85 mmHg) 24 weeks and 48 weeks after randomization. In addition, the study will assess the psychological determinants of adherence and persistence to drug therapy, through specific psychological tests administered during the course of the study. Other secondary study endpoints will be related to the impact of HBPT on additional clinical and economic outcomes (number of additional medical visits, direct costs of patient management, number of antihypertensive drugs prescribed, level of cardiovascular risk, degree of target organ damage and rate of cardiovascular events, regression of the metabolic syndrome).DiscussionThe TELEBPMET Study will show whether HBPT is effective in improving blood pressure control and related medical and economic outcomes in hypertensive patients with metabolic syndrome. It will also provide a comprehensive understanding of the psychological determinants of medication adherence and blood pressure control of these patients.Trial registrationClinical Trials.gov: NCT01541566
Highlights
Inadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, of those at high risk of cardiovascular events
It will provide a comprehensive understanding of the psychological determinants of medication adherence and blood pressure control of these patients
Study objectives The study aims at investigating whether in high-risk patients with hypertension and metabolic syndrome, daytime ambulatory blood pressure control over 48 weeks is more effective when based on regular home blood pressure telemonitoring (HBPT), through monthly automated blood pressure teletransmission and feedback to the patient by the doctor, rather than when based only on periodic measurements made by doctors in their office during quarterly visits (conventional management (CM) control group)
Summary
Inadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, of those at high risk of cardiovascular events. Preliminary evidence suggests that home blood pressure telemonitoring (HBPT) might help increasing the chance of achieving blood pressure targets and improve patient’s therapeutic adherence. Numerous studies have shown that antihypertensive treatment may reduce cardiovascular risk and despite availability of several valuable antihypertensive drug options, today, no more than 30% of treated hypertensive patients maintain a satisfactory blood pressure control [1,7]. This may be caused by many factors, among which poor or complete lack of adherence to treatment prescriptions have been reported to play a major role. Compliance to therapy seems to be related to many factors including the high number of pills to be taken daily, an excessive cost of the available medications, the lack of motivation and poor patient’s involvement in the management of this clinical condition, the long wait in the doctor’s office, the absence of symptoms, the inability of the patient to understand the real long-term consequences of high blood pressure, and the psychological and personality traits of the patients [8]
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