Study protocol
Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study)
1 Department of Cardiology, IRCCS Ospedale San Luca, Istituto Auxologico Italiano and Department of Clinical Medicine and Prevention, University of Milano Bicocca, Milano, Italy
2 Italian Institute of Telemedicine, Varese, Italy
3 Department of Human Sciences, University of Bergamo, Bergamo, Italy
4 Scientific Advisor, Centro Diagnostico Italiano, Milan, Italy
5 Department of Pediatric Cardiology & Adult with Congenital Heart Centre, IRCCS Policlinico San Donato, Milan, Italy
6 Medicina Generale II, Centro Ipertensione, University of Insubria, Ospedale di Circolo, Varese, Italy
7 General Medicine Unit, Treviglio-Caravaggio Hospital, Medical Department AO, Treviglio, Italy
8 Divisione di Nefrologia ed Emodialisi, IRCCS Fondazione Salvatore Maugeri, Istituto Scientifico di Pavia, Pavia, Italy
9 Istituto di Clinica Medica IV, Policlinico Universitario, University of Padova, Padova, Italy
10 Clinica Medica, University of Brescia, II Medicina Generale, A.O. Spedali Civili di Brescia, Brescia, Italy
11 Servizio Autonomo di Telemedicina, IRCCS Fondazione Salvatore Maugeri, Lumezzane, Brescia, Italy
12 Dipartimento di Medicina Interna, Azienda Ospedaliera Universitaria di Santa Chiara, University of Pisa, Pisa, Italy
13 Ospedale S Giovanni Calibita Fatebenefratelli, Roma, Italy
14 U.O. Cardiologia, Azienda Ospedaliera Policlinico, University of Bari, Bari, Italy
15 U.O.S.D. Servizio di Prevenzione e Riabilitazione Cardiopatico, Centro di Prevenzione Malattie Cardiovascolari, Presidio Ospedaliero San Felice a Cancello, San Felice a Cancello, Caserta, Italy
16 Casa di Cura Tortorella, Salerno, Italy
Trials 2013, 14:22 doi:10.1186/1745-6215-14-22
Published: 23 January 2013Abstract
Background
Inadequate 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/design
The 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).
Discussion
The 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 registration
Clinical Trials.gov: NCT01541566
