Telemonitoring of Blood Pressure in Local Pharmacies

NCT03781401 | Recruiting FDA Device

• 1 other identifier: TEMPLAR
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 24-hour blood pressure control rate

  The percentage of patients with an average 24-hour blood pressure \<130/80 mmHg

  10 years

Secondary Outcomes (7)

• Office blood pressure control rate

  10 years

• Day-time blood pressure control rate

  10 years

• Night-time blood pressure control

  10 years

• Evaluation of blood pressure control in treated vs. untreated subjects

  10 years

• Rate of patients with white-coat hypertension

  10 years

Interventions

Ambulatory blood pressure monitoring DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Italian Institute of Telemedicine: lead
• Italian Society of Hypertension: collaborator
• Italian Society of General Practitioners: collaborator
• Biotechmed Ltd.: collaborator

Study Sites (1)

Italian Institute of Telemedicine

Solbiate Arno, Italy

RECRUITING

Related Publications (13)

• 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.

  PMID: 30976783 RESULT

• 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.

  PMID: 30037524 RESULT

• 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.

  PMID: 27072129 RESULT

• 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.

  PMID: 25578090 RESULT

• 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.

  PMID: 32536214 RESULT

• 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.

  PMID: 32506273 RESULT

• 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.

  PMID: 32921195 RESULT

• 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.

  PMID: 34102664 RESULT

• 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.

  PMID: 34587198 RESULT

• 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.

  PMID: 35585169 RESULT

• 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.

  PMID: 36453645 RESULT

• 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.

  PMID: 37017033 RESULT

• 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.

  PMID: 37315119 RESULT

Related Links

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

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Stefano Omboni, MD

  Italian Institute of Telemedicine

  STUDY DIRECTOR

Central Study Contacts

Stefano Omboni, MD

CONTACT

+390331984176

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: October 1, 2010
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)