1. 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)
- Author
-
Gianfranco, Parati, Stefano, Omboni, Angelo, Compare, Enzo, Grossi, Edward, Callus, Achille, Venco, Maurizio, Destro, Giuseppe, Villa, Paolo, Palatini, Enrico Agabiti, Rosei, Simonetta, Scalvini, Stefano, Taddei, Dario, Manfellotto, Stefano, Favale, Carmine, De Matteis, Michele, Guglielmi, Laura, Lonati, Francesco, Della Rosa, Ellen, Tosazzi, Anna Maria, Grandi, Andrea Maria, Maresca, Christian, Mongiardi, Micaela, Mare, Alessandra Rossi, Ricci, Francesca, Cagnoni, Joannhe, Georgatos, Valeria, Besostri, Viviana, Ferrari, Ombretta, Omodeo, Francesca, Dorigatti, Elisa, Bonso, Chiara, Guarnieri, Lorenza, Muiesan, Anna, Paini, Deborah, Stassaldi, Angelo, Cinelli, Palmira, Bernocchi, Silvana, Rocchi, Armando, Magagna, Lorenzo, Ghiadoni, Irene, Del Frate, Francesca, Boresi, Antonella, Guidi, Maria Antonietta, Re, Luisa, Pellicciotti, Antonia, Florio, Giuliana, Morani, Silvana, Di Lillo, Antonietta, Ambrosio, Antonio, Casciello, Maria, Quaglia, Cinzia, Forleo, Maria Annunziata, Ardito, Stefania, Gerunda, Mariligia, Panunzio, Parati, G, Omboni, S, Compare, A, Grossi, E, Callus, E, Venco, A, Destro, M, Villa, G, Palatini, P, Agabiti Rosei, E, Scalvini, S, Taddei, S, Manfellotto, D, Favale, S, De Matteis, C, and Guglielmi, M
- Subjects
Telemedicine ,medicine.medical_specialty ,Medicine (miscellaneous) ,Anxiety ,law.invention ,Medication Adherence ,Study Protocol ,Randomized controlled trial ,Clinical Protocols ,law ,Settore M-PSI/08 - Psicologia Clinica ,Outcome Assessment, Health Care ,medicine ,Humans ,Pharmacology (medical) ,Personality traits ,Intensive care medicine ,Depression (differential diagnoses) ,Protocol (science) ,Metabolic Syndrome ,Hypertension, Blood pressure, Home blood pressure telemonitoring, Adherence, Anxiety, Depression, Personality traits ,lcsh:R5-920 ,Hypertension ,blood pressure ,home blood pressure telemonitoring ,adherence ,anxiety ,depression ,personality traits ,business.industry ,Depression ,MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Blood Pressure Monitoring, Ambulatory ,medicine.disease ,Home blood pressure telemonitoring ,Blood pressure ,Adherence ,Ambulatory ,medicine.symptom ,Metabolic syndrome ,business ,lcsh:Medicine (General) - Abstract
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 ( 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
- Published
- 2013