Clinical trial NCT01541566: Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring and Assessment of Psychological Determinants
Official title: Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Metabolic Syndrome
Keywords: arterial hypertension
metabolic syndrome
home blood pressure
ambulatory blood pressure
office blood pressure
telemedicine
Lead sponsor: Italian Institute of Telemedicine
Sponsor class: OTHER
Collaborators: name: Bracco Corporate
name: Istituto Auxologico Italiano
First posted: 2012-03-01
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referring to 12 Hypertension Centers (Hospitals) and suffering from arterial hypertension associated to metabolic syndrome

Brief summary: The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.


Eligibility criteria: Inclusion Criteria:

* Treated or untreated uncontrolled essential arterial hypertension (office systolic blood pressure \>140 or diastolic \>90 mmHg + day-time systolic blood pressure \>135 or day-time diastolic blood pressure \>85 mmHg)
* Metabolic syndrome (ATP III criteria)

Exclusion Criteria:

* Secondary arterial hypertension
* Severe liver or kidney disease
* Immunological disease
* Cardiac arrhythmias

Primary outcomes:
measure: Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg
timeFrame: 6 months
measure: Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg
timeFrame: 12 months
Secondary outcomes:
measure: Psychological determinats of therapeutic adherence
timeFrame: 6 months
measure: Percentage of subjects with office blood pressure <140/90 mmHg
timeFrame: 6 months
measure: Changes in home blood pressure
timeFrame: 6 months
measure: Number of additional medical visits
timeFrame: 6 months
measure: Direct costs of intervention
timeFrame: 6 months
measure: Number of antihypertensive drugs
timeFrame: 6 months
measure: Level of cardiovascular risk by ESC Heart Score and Framingham
timeFrame: 6 months
measure: Target organ damage and outcomes
timeFrame: 6 months
measure: Percentage of patients with metabolic syndrome
timeFrame: 6 months
measure: Psychological determinats of therapeutic adherence
timeFrame: 12 months
measure: Percentage of subjects with office blood pressure <140/90 mmHg
timeFrame: 12 months
measure: Changes in home blood pressure
timeFrame: 12 months
measure: Number of additional medical visits
timeFrame: 12 months
measure: Direct costs of intervention
timeFrame: 12 months
measure: Number of antihypertensive drugs
timeFrame: 12 months
measure: Level of cardiovascular risk by ESC Heart Score and Framingham
timeFrame: 12 months
measure: Target organ damage and outcomes
timeFrame: 12 months
measure: Percentage of patients with metabolic syndrome
timeFrame: 12 months
measure: Percentage of subjects with home blood pressure <135/85 mmHg
timeFrame: 6 months
measure: Percentage of subjects with home blood pressure <135/85 mmHg
timeFrame: 12 months
measure: Changes in 24h blood pressure
timeFrame: 6 months
measure: Changes in 24h blood pressure
timeFrame: 12 months
measure: Changes in office blood pressure
timeFrame: 6 months
measure: Changes in office blood pressure
timeFrame: 12 months
measure: Adherence to treatment
timeFrame: 6 months
measure: Adherence to treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Fondazione Maugeri
state: Brescia
city: San Felice a Cancello
country: Italy
facility: Ospedale San Felice a Cancello
state: Caserta
city: Broni
country: Italy
facility: Ospedale di Broni
state: Pavia
city: Bari
country: Italy
facility: Policlinico Universitario
city: Brescia
country: Italy
facility: Spedali Civili
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
city: Padova
country: Italy
facility: Policlinico Universitario
city: Pavia
country: Italy
facility: Fondazione Maugeri
city: Pisa
country: Italy
facility: Ospedale Santa Chiara
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli
city: Salerno
country: Italy
facility: Casa di Cura Tortorella
city: Varese
country: Italy
facility: Ospedale di Circolo
Study officials:
affiliation: Istituto Auxologico Italiano
name: Gianfranco Parati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brugnera A, Compare A, Omboni S, Greco A, Carrara S, Tasca GA, Poletti B, Parati G. Psychological covariates of blood pressure among patients with hypertension and metabolic syndrome. Health Psychol. 2022 Dec;41(12):946-954. doi: 10.1037/hea0001205. Epub 2022 Jul 21.
citation: Parati G, Omboni S, Compare A, Grossi E, Callus E, Venco A, Destro M, Villa G, Palatini P, Rosei EA, Scalvini S, Taddei S, Manfellotto D, Favale S, De Matteis C, Guglielmi M; TELEBPMET Study Group; Lonati L, Della Rosa F, Tosazzi E, Grandi AM, Maresca AM, Mongiardi C, Mare M, Ricci AR, Cagnoni F, Georgatos J, Besostri V, Ferrari V, Omodeo O, Dorigatti F, Bonso E, Guarnieri C, Muiesan L, Paini A, Stassaldi D, Cinelli A, Bernocchi P, Rocchi S, Magagna A, Ghiadoni L, Del Frate I, Boresi F, Guidi A, Re MA, Pellicciotti L, Florio A, Morani G, Di Lillo S, Ambrosio A, Casciello A, Quaglia M, Forleo C, Ardito MA, Gerunda S, Panunzio M. 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. 2013 Jan 23;14:22. doi: 10.1186/1745-6215-14-22.