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Arterial HypertensionTELEBPMETNCT01541566

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

An observational study of Arterial Hypertension and Metabolic Syndrome, run by Italian Institute of Telemedicine at 12 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Arterial Hypertension, Metabolic Syndrome
How many people
254 participants
Where
12 sitesItaly
Study dates
Nov 2007to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Italy12 sites

  • Policlinico Universitario

    Bari, Bari, 70124

  • Spedali Civili

    Brescia, Brescia, 25123

  • Ospedale di Broni

    Broni, Pavia, 27043

  • Fondazione Maugeri

    Lumezzane, Brescia, 25066

  • Istituto Auxologico Italiano

    Milan, Milano, 20149

  • Policlinico Universitario

    Padova, Padova, 35128

  • Fondazione Maugeri

    Pavia, Pavia, 27100

  • Ospedale Santa Chiara

    Pisa, Pisa, 56100

  • Ospedale Fatebenefratelli

    Roma, Roma, 00186

  • Casa di Cura Tortorella

    Salerno, Salerno, 84122

  • Ospedale San Felice a Cancello

    San Felice A Cancello, Caserta, 81027

  • Ospedale di Circolo

    Varese, Varese, 21100

Other trials in Italy

About this study

Official title: 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.

Keywords
arterial hypertension, metabolic syndrome, home blood pressure, ambulatory blood pressure, office blood pressure, telemedicine
Medical subject headings
Hypertension, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01541566
Study groupRoleWhat they receive
Home blood pressure telemonitoringPatients 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 measurementBlood pressure measured only in the doctor's office during quarterly visits, without regular home blood pressure monitoring.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg

    Measured: 6 months

  2. Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg

    Measured: 12 months

Secondary outcomes (26)

  1. Psychological determinats of therapeutic adherence

    Measured: 6 months

  2. Percentage of subjects with office blood pressure <140/90 mmHg

    Measured: 6 months

  3. Changes in home blood pressure

    Measured: 6 months

  4. Number of additional medical visits

    Measured: 6 months

  5. Direct costs of intervention

    Measured: 6 months

  6. Number of antihypertensive drugs

    Measured: 6 months

  7. Level of cardiovascular risk by ESC Heart Score and Framingham

    Measured: 6 months

  8. Target organ damage and outcomes

    Measured: 6 months

  9. Percentage of patients with metabolic syndrome

    Measured: 6 months

  10. Psychological determinats of therapeutic adherence

    Measured: 12 months

  11. Percentage of subjects with office blood pressure <140/90 mmHg

    Measured: 12 months

  12. Changes in home blood pressure

    Measured: 12 months

  13. Number of additional medical visits

    Measured: 12 months

  14. Direct costs of intervention

    Measured: 12 months

  15. Number of antihypertensive drugs

    Measured: 12 months

  16. Level of cardiovascular risk by ESC Heart Score and Framingham

    Measured: 12 months

  17. Target organ damage and outcomes

    Measured: 12 months

  18. Percentage of patients with metabolic syndrome

    Measured: 12 months

  19. Percentage of subjects with home blood pressure <135/85 mmHg

    Measured: 6 months

  20. Percentage of subjects with home blood pressure <135/85 mmHg

    Measured: 12 months

  21. Changes in 24h blood pressure

    Measured: 6 months

  22. Changes in 24h blood pressure

    Measured: 12 months

  23. Changes in office blood pressure

    Measured: 6 months

  24. Changes in office blood pressure

    Measured: 12 months

  25. Adherence to treatment

    Measured: 6 months

  26. Adherence to treatment

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2012 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541566
Sponsor's protocol ID
TELEBPMET
Acronym
TELEBPMET
Status last verified
Feb 2016
First submitted
17 Feb 2012
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 35862126

  • 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.

    PubMed 23343138

Questions about this trial

What is this clinical trial studying?

An observational study of Arterial Hypertension and Metabolic Syndrome, run by Italian Institute of Telemedicine at 12 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01541566, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.

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