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).
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
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).


CONCLUSIONS
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.


BACKGROUND
Clinical Trials.gov: NCT01541566.
Department of Cardiology, IRCCS Ospedale San Luca, Istituto Auxologico Italiano, Milano, Italy. gianfranco.parati@unimib.it
Gianfranco
G
Parati
Stefano
S
Omboni
Angelo
A
Compare
Enzo
E
Grossi
Edward
E
Callus
Achille
A
Venco
Maurizio
M
Destro
Giuseppe
G
Villa
Paolo
P
Palatini
Enrico Agabiti
EA
Rosei
Simonetta
S
Scalvini
Stefano
S
Taddei
Dario
D
Manfellotto
Stefano
S
Favale
Carmine
C
De Matteis
Michele
M
Guglielmi
Laura
L
Lonati
Francesco
F
Della Rosa
Ellen
E
Tosazzi
Anna Maria
AM
Grandi
Andrea Maria
AM
Maresca
Christian
C
Mongiardi
Micaela
M
Mare
Alessandra Rossi
AR
Ricci
Francesca
F
Cagnoni
Joannhe
J
Georgatos
Valeria
V
Besostri
Viviana
V
Ferrari
Ombretta
O
Omodeo
Francesca
F
Dorigatti
Elisa
E
Bonso
Chiara
C
Guarnieri
Lorenza
L
Muiesan
Anna
A
Paini
Deborah
D
Stassaldi
Angelo
A
Cinelli
Palmira
P
Bernocchi
Silvana
S
Rocchi
Armando
A
Magagna
Lorenzo
L
Ghiadoni
Irene
I
Del Frate
Francesca
F
Boresi
Antonella
A
Guidi
Maria Antonietta
MA
Re
Luisa
L
Pellicciotti
Antonia
A
Florio
Giuliana
G
Morani
Silvana
S
Di Lillo
Antonietta
A
Ambrosio
Antonio
A
Casciello
Maria
M
Quaglia
Cinzia
C
Forleo
Maria Annunziata
MA
Ardito
Stefania
S
Gerunda
Mariligia
M
Panunzio
D018660:Blood Pressure Monitoring, Ambulatory; D002985:Clinical Protocols; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D055118:Medication Adherence; D024821:Metabolic Syndrome / Q000503:physiopathology*; D017063:Outcome Assessment, Health Care; D017216:Telemedicine