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)

Trials

Michele Guglielmi⁸  Carmine De Matteis^1,11  Stefano Favale¹  Dario Manfellotto⁹  Stefano Taddei²  Simonetta Scalvini^1,13  Enrico Agabiti Rosei⁵  Paolo Palatini³  Giuseppe Villa^1,15  Maurizio Destro⁷  Achille Venco⁶  Edward Callus^1,12  Enzo Grossi^1,16  Angelo Compare^1,10  Stefano Omboni⁴  Gianfranco Parati^1,14 

[1] U.O. Cardiologia, Azienda Ospedaliera Policlinico, University of Bari, Bari, Italy;Dipartimento di Medicina Interna, Azienda Ospedaliera Universitaria di Santa Chiara, University of Pisa, Pisa, Italy;Istituto di Clinica Medica IV, Policlinico Universitario, University of Padova, Padova, Italy;Italian Institute of Telemedicine, Varese, Italy;Clinica Medica, University of Brescia, II Medicina Generale, A.O. Spedali Civili di Brescia, Brescia, Italy;Medicina Generale II, Centro Ipertensione, University of Insubria, Ospedale di Circolo, Varese, Italy;General Medicine Unit, Treviglio-Caravaggio Hospital, Medical Department AO, Treviglio, Italy;Casa di Cura Tortorella, Salerno, Italy;Ospedale S Giovanni Calibita Fatebenefratelli, Roma, Italy;Department of Human Sciences, University of Bergamo, Bergamo, Italy;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;Department of Pediatric Cardiology & Adult with Congenital Heart Centre, IRCCS Policlinico San Donato, Milan, Italy;Servizio Autonomo di Telemedicina, IRCCS Fondazione Salvatore Maugeri, Lumezzane, Brescia, Italy;Department of Cardiology, IRCCS Ospedale San Luca, Istituto Auxologico Italiano and Department of Clinical Medicine and Prevention, University of Milano Bicocca, Milano, Italy;Divisione di Nefrologia ed Emodialisi, IRCCS Fondazione Salvatore Maugeri, Istituto Scientifico di Pavia, Pavia, Italy;Scientific Advisor, Centro Diagnostico Italiano, Milan, Italy

关键词: Personality traits;    Depression;    Anxiety;    Adherence;    Home blood pressure telemonitoring;    Blood pressure;    Hypertension;   

Others  :  1094915
DOI  :  10.1186/1745-6215-14-22

 received in 2012-07-09, accepted in 2012-12-03,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Parati et al.; licensee BioMed Central Ltd.

【 图 表 】

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