Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Jan 23:14:22.
doi: 10.1186/1745-6215-14-22.

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)

Gianfranco Parati  1 , 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; TELEBPMET Study Group; 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
Affiliations
Randomized Controlled Trial

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)

Gianfranco Parati et al. Trials. .

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 (< 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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow chart of the TELEBPMET study design. ATP, Adult Treatment Panel; BP, Blood pressure; CM, Conventional management; HBPT, Home blood pressure telemonitoring; W, Week.
Figure 2
Figure 2
The Morepress web-based telemedicine system used in the TELEBPMET Study. GPRS, General Packet Radio Service; HBPT, Home blood pressure telemonitoring; SSL, Secure Sockets Layer.
Figure 3
Figure 3
Timing and content of study assessments. ABPM, Ambulatory blood pressure monitoring; BP, Blood pressure; HBPT, Home blood pressure telemonitoring.
See this image and copyright information in PMC

References

    1. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005;365:217–223. - PubMed
    1. Lawes CM, Vander Hoorn S, Law MR, Elliott P, MacMahon S, Rodgers A. Blood pressure and the global burden of disease, Part II: estimates of attributable burden. J Hypertens. 2000;2006(24):423–430. - PubMed
    1. Malik S, Wong ND, Franklin SS, Kamath TV, L'Italien GJ, Pio JR, Williams GR. Impact of the metabolic syndrome on mortality from coronary heart disease, cardiovascular disease, and all causes in United States adults. Circulation. 2004;110:1245–1250. doi: 10.1161/01.CIR.0000140677.20606.0E. - DOI - PubMed
    1. Lakka HM, Laaksonen DE, Lakka TA, Niskanen LK, Kumpusalo E, Tuomilehto J, Salonen JT. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA. 2002;288:2709–2716. doi: 10.1001/jama.288.21.2709. - DOI - PubMed
    1. Isomaa B, Almgren P, Tuomi T, Forsen B, Lahti K, Nissen M, Taskinen MR, Groop L. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care. 2001;24:683–689. doi: 10.2337/diacare.24.4.683. - DOI - PubMed

Publication types

Associated data