Telemonitoring of Blood Pressure in Local Pharmacies (TEMPLAR)

October 4, 2024 updated by: Italian Institute of Telemedicine

Blood Pressure Telemonitoring in Local Pharmacies and Blood Pressure Control in the Community

The TEMPLAR project is an observational, cross-sectional, multicenter study involving several community pharmacies spread all over Italy. The aim of the project, the currently largest Italian ABPM Registry, is to analyze the 24-hour ABPMs performed in community pharmacies enabled for this service in accordance with the current Italian regulations, in order to evaluate the level of BP control in the community and to provide scientific evidence on the usefulness of a telehealth network involving the pharmacist for the screening and control of hypertension.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The recent introduction of second-level services in Pharmacy, has resulted in the gradual diffusion of some techniques, which, under medical supervision, have enormous potential in improving screening, prevention and control of the most common chronic diseases. Among these services, 24-hour and home blood pressure monitoring are the most commonly available. The introduction of blood pressure monitoring in Pharmacy, under medical prescription, supervision and reporting, plays an important scientific role. As a matter of fact, the collected data can be useful for taking a picture of the status of the blood pressure control in a setting different from that of the Hospital or Hypertension Clinic. These data can also help to evaluate the usefulness of such a service in terms of improvement of public health and as a support to Doctor's intervention.

The aim of the project is to assess the level of blood pressure control in patients undergoing 24-hour or home blood pressure monitoring through Pharmacies enabled for this service in accordance with the current local laws. Specific objectives of the project are: a) to verify whether such a service is really useful in terms of hypertension screening, b) to assess the real blood pressure control of hypertensive patients pharmacologically treated, c) to typify the degree of blood pressure control according to the main demographic and clinical characteristics of the subjects.

This is an observational, cross-sectional, multicenter study involving Pharmacies spread all over Italy. These Pharmacies already make use of a telemonitoring and telereporting system based on 24-hour and home blood pressure monitoring, with centralized data collection. The service is developed in accordance with the rules governing the second-level services payable in Pharmacy (DL 03/10/2009 n. 153 and DM 16/12/2010) and with the legislation on protection of personal data (DL 30/06/2003 n. 196). The service is provided in accordance with the current Guidelines of the Italian Society of Hypertension and the European Society of Hypertension and is managed by Doctors expert of the methodology. The service is offered to patients upon payment and the test is prescribed by the General Practitioner (referring physician of the patient). The data collected as part of the service provided by the single Pharmacies are analyzed for the purposes of the Project. The project foresees the analysis of blood pressure recordings and clinical data of subjects of both sexes, aged ≥ 18 years, undergoing a 24-hour or home blood pressure monitoring because of a suspected hypertension (patients not pharmacologically treated) or to verify the degree of blood pressure control with antihypertensive drug therapy (patients under treatment).

Study Type

Observational

Enrollment (Estimated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stefano Omboni, MD
  • Phone Number: +390331984176

Study Locations

  • Italy
      • Solbiate Arno, Italy
        • Recruiting
        • Italian Institute of Telemedicine
        • Contact:
          • Stefano Omboni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients of both sexes and of any age with conventional clinical indications for ABPM (either treated with antihypertensive drugs or untreated) referred to the pharmacy by their family doctors for diagnostic purposes (established or suspected arterial hypertension).

Description

Inclusion Criteria:

  • Consecutive patients of both sexes and of any age
  • Conventional clinical indications for ABPM (either treated with antihypertensive drugs or untreated)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour blood pressure control rate
Time Frame: 10 years
The percentage of patients with an average 24-hour blood pressure <130/80 mmHg
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Office blood pressure control rate
Time Frame: 10 years
The percentage of patients with an office blood pressure <140/90 mmHg
10 years
Day-time blood pressure control rate
Time Frame: 10 years
The percentage of patients with an average day-time blood pressure <135/85 mmHg
10 years
Night-time blood pressure control
Time Frame: 10 years
The percentage of patients with an average night-time blood pressure <120/70 mmHg
10 years
Evaluation of blood pressure control in treated vs. untreated subjects
Time Frame: 10 years
The percentage of treated vs. untreated patients with blood pressure control
10 years
Rate of patients with white-coat hypertension
Time Frame: 10 years
Percentage of patients with an office SBP ≥140 mmHg and/or DBP ≥90 mmHg + 24-hour average BP <130/80 mmHg + day-time average BP <135/85 mmHg + night-time average BP <120/70 mmHg
10 years
Rate of patients with masked hypertension
Time Frame: 10 years
Percentage of patients with an office BP <140/90 mmHg + 24-hour average SBP ≥130 mmHg and/or DBP ≥80 mmHg or day-time average SBP ≥135 mmHg and/or DBP ≥85 mmHg or night-time average SBP ≥120 mmHg and/or DBP ≥70 mmHg
10 years
Blood pressure control in subgroups at risk
Time Frame: 10 years
Rate of office and ambulatory blood pressure control according to sex, age, cardiovascular risk factors and concomitant diseases
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Institute of Telemedicine

Collaborators

Italian Society of Hypertension
Italian Society of General Practitioners
Biotechmed Ltd.

Investigators

  • Study Director: Stefano Omboni, MD, Italian Institute of Telemedicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEMPLAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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