Telemonitoring of Blood Pressure in Local Pharmacies

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: Ambulatory blood pressure monitoring


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ambulatory blood pressure monitoring|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour blood pressure control rate | 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 | The percentage of patients with an office blood pressure <140/90 mmHg | 10 years | 
| Day-time blood pressure control rate | The percentage of patients with an average day-time blood pressure <135/85 mmHg | 10 years | 
| Night-time blood pressure control | 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 | The percentage of treated vs. untreated patients with blood pressure control | 10 years | 
| 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 | 
| 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 | 
| 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 |