Telemonitoring of Blood Pressure in Local Pharmacies

Hypertension Clinical Trial

— TEMPLAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781401
• Other study ID #: TEMPLAR
• Status: Recruiting
• Start date: October 2010
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Italian Institute of Telemedicine
• Contact: Stefano Omboni, MD
• Phone: +390331984176
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Ambulatory blood pressure monitoring

Locations

Country	Name	City	State
Italy	Italian Institute of Telemedicine	Solbiate Arno

Sponsors (4)

Lead Sponsor	Collaborator
Italian Institute of Telemedicine	Biotechmed Ltd., Italian Society of General Practitioners, Italian Society of Hypertension

Country where clinical trial is conducted

Italy, 

References & Publications (13)

Omboni S, Ballatore T, Rizzi F, Tomassini F, Campolo L, Panzeri E, Lundwall K, Kahan T. 24-hour ambulatory blood pressure telemonitoring in patients at risk of atrial fibrillation: results from the TEMPLAR project. Hypertens Res. 2022 Sep;45(9):1486-1495. — View Citation

Omboni S, Ballatore T, Rizzi F, Tomassini F, Campolo L, Panzeri E. Age-related patterns of ambulatory blood pressure in a large cohort of individuals referred to Italian community pharmacies: results from the templar project. J Hypertens. 2023 Feb 1;41(2) — View Citation

Omboni S, Ballatore T, Rizzi F, Tomassini F, Campolo L, Panzeri E. Feasibility of 24-h blood pressure telemonitoring in community pharmacies: the TEMPLAR project. J Hypertens. 2021 Oct 1;39(10):2075-2081. doi: 10.1097/HJH.0000000000002895. — View Citation

Omboni S, Ballatore T, Rizzi F, Tomassini F, Panzeri E, Campolo L. Telehealth at scale can improve chronic disease management in the community during a pandemic: An experience at the time of COVID-19. PLoS One. 2021 Sep 29;16(9):e0258015. doi: 10.1371/jou — View Citation

Omboni S, Campolo L, Panzeri E. Telehealth in chronic disease management and the role of the Internet-of-Medical-Things: the Tholomeus(R) experience. Expert Rev Med Devices. 2020 Jul;17(7):659-670. doi: 10.1080/17434440.2020.1782734. Epub 2020 Jun 30. — View Citation

Omboni S, Caserini M, Coronetti C. Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. High Blood Press Cardiovasc Prev. 2016 Sep;23(3):187-96. doi: 10.1007/s40292-016-0143-6. Epub 2016 Apr 12. — View Citation

Omboni S, Khan NA, Kunadian V, Olszanecka A, Schutte AE, Mihailidou AS. Sex Differences in Ambulatory Blood Pressure Levels and Subtypes in a Large Italian Community Cohort. Hypertension. 2023 Jul;80(7):1417-1426. doi: 10.1161/HYPERTENSIONAHA.122.20589. E — View Citation

Omboni S, Mancinelli A, Rizzi F, Parati G; TEMPLAR (TEleMonitoring of blood Pressure in Local phARmacies) Project Group. Telemonitoring of 24-Hour Blood Pressure in Local Pharmacies and Blood Pressure Control in the Community: The Templar Project. Am J Hy — View Citation

Omboni S, McManus RJ, Bosworth HB, Chappell LC, Green BB, Kario K, Logan AG, Magid DJ, Mckinstry B, Margolis KL, Parati G, Wakefield BJ. Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International — View Citation

Omboni S, Panzeri E, Campolo L. E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring. Curr Hypertens Rep. 2020 Jun 6;22(6):42. doi: 10.1007/s11906-020-01056-y. — View Citation

Omboni S, Sala E. The pharmacist and the management of arterial hypertension: the role of blood pressure monitoring and telemonitoring. Expert Rev Cardiovasc Ther. 2015 Feb;13(2):209-21. doi: 10.1586/14779072.2015.1001368. Epub 2015 Jan 12. — View Citation

Omboni S, Tenti M. Telepharmacy for the management of cardiovascular patients in the community. Trends Cardiovasc Med. 2019 Feb;29(2):109-117. doi: 10.1016/j.tcm.2018.07.002. Epub 2018 Jul 12. — View Citation

Omboni S. Reply to 'Extreme dipping: is the nocturnal blood pressure fall modulated by age?'. J Hypertens. 2023 May 1;41(5):868-869. doi: 10.1097/HJH.0000000000003388. No abstract available. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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

External Links

•   The certified web-based telemedicine platform used to collect the data for the TEMPLAR Project.
•   The official website of the TEMPLAR project with updates on the status of the study and current findings.