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 (TELEBPMET)

Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Arterial Hypertension

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Policlinico Universitario
  • Brescia, Italy, 25123
    • Spedali Civili
  • Milano, Italy, 20149
    • Istituto Auxologico Italiano
  • Padova, Italy, 35128
    • Policlinico Universitario
  • Pavia, Italy, 27100
    • Fondazione Maugeri
  • Pisa, Italy, 56100
    • Ospedale Santa Chiara
  • Roma, Italy, 00186
    • Ospedale Fatebenefratelli
  • Salerno, Italy, 84122
    • Casa di Cura Tortorella
  • Varese, Italy, 21100
    • Ospedale di Circolo
  • Brescia
    • Lumezzane, Brescia, Italy, 25066
      • Fondazione Maugeri
  • Caserta
    • San Felice a Cancello, Caserta, Italy, 81027
      • Ospedale San Felice a Cancello
  • Pavia
    • Broni, Pavia, Italy, 27043
      • Ospedale di Broni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients referring to 12 Hypertension Centers (Hospitals) and suffering from arterial hypertension associated to metabolic syndrome

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Home blood pressure telemonitoring; Patients regularly monitoring their blood pressure at home with an electronic validated upper arm device, transmitting blood pressure values at monthly intervals to the doctors office through the Internet.
Conventional blood pressure measurement; Blood pressure measured only in the doctor's office during quarterly visits, without regular home blood pressure monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg	6 months
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Psychological determinats of therapeutic adherence	6 months
Percentage of subjects with office blood pressure <140/90 mmHg	6 months
Changes in home blood pressure	6 months
Number of additional medical visits	6 months
Direct costs of intervention	6 months
Number of antihypertensive drugs	6 months
Level of cardiovascular risk by ESC Heart Score and Framingham	6 months
Target organ damage and outcomes	6 months
Percentage of patients with metabolic syndrome	6 months
Psychological determinats of therapeutic adherence	12 months
Percentage of subjects with office blood pressure <140/90 mmHg	12 months
Changes in home blood pressure	12 months
Number of additional medical visits	12 months
Direct costs of intervention	12 months
Number of antihypertensive drugs	12 months
Level of cardiovascular risk by ESC Heart Score and Framingham	12 months
Target organ damage and outcomes	12 months
Percentage of patients with metabolic syndrome	12 months
Percentage of subjects with home blood pressure <135/85 mmHg	6 months
Percentage of subjects with home blood pressure <135/85 mmHg	12 months
Changes in 24h blood pressure	6 months
Changes in 24h blood pressure	12 months
Changes in office blood pressure	6 months
Changes in office blood pressure	12 months
Adherence to treatment	6 months
Adherence to treatment	12 months

Collaborators and Investigators

• Sponsor: Italian Institute of Telemedicine
• Collaborators: Istituto Auxologico Italiano; Bracco Corporate
• Investigators: Principal Investigator: Gianfranco Parati, MD, Istituto Auxologico Italiano

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: telemedicine; metabolic syndrome; ambulatory blood pressure; arterial hypertension; office blood pressure; home blood pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Hypertension; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: TELEBPMET