Clinical trial NCT03781401: Telemonitoring of Blood Pressure in Local Pharmacies
Official title: Blood Pressure Telemonitoring in Local Pharmacies and Blood Pressure Control in the Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Lead sponsor: Italian Institute of Telemedicine
Sponsor class: OTHER
Collaborators: name: Italian Society of Hypertension
name: Italian Society of General Practitioners
name: Biotechmed Ltd.
First posted: 2018-12-19
Enrollment: 40000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: 24-hour blood pressure control rate
timeFrame: 10 years
Secondary outcomes:
measure: Office blood pressure control rate
timeFrame: 10 years
measure: Day-time blood pressure control rate
timeFrame: 10 years
measure: Night-time blood pressure control
timeFrame: 10 years
measure: Evaluation of blood pressure control in treated vs. untreated subjects
timeFrame: 10 years
measure: Rate of patients with white-coat hypertension
timeFrame: 10 years
measure: Rate of patients with masked hypertension
timeFrame: 10 years
measure: Blood pressure control in subgroups at risk
timeFrame: 10 years
Other outcomes:
Locations:
city: Solbiate Arno
country: Italy
facility: Italian Institute of Telemedicine
Study officials:
affiliation: Italian Institute of Telemedicine
name: Stefano Omboni, MD
role: STUDY_DIRECTOR
References:
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 Hypertens. 2019 Jun 11;32(7):629-639. doi: 10.1093/ajh/hpz049.
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.
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.
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.
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.
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.
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 Expert Position Paper. Hypertension. 2020 Nov;76(5):1368-1383. doi: 10.1161/HYPERTENSIONAHA.120.15873. Epub 2020 Sep 14.
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.
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/journal.pone.0258015. eCollection 2021.
citation: 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. doi: 10.1038/s41440-022-00932-1. Epub 2022 May 18.
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):336-343. doi: 10.1097/HJH.0000000000003337. Epub 2022 Nov 28.
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.
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. Epub 2023 May 12.