Knowledge of Vascular Age Contributes to Improve the Collaboration Between Community Pharmacies and Primary Health Care Physicians in Reducing Blood Pressure in Hypertensive Patients.

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard BP intervention: Behavioral: lifestyle counseling will be given according to international guidelines to reduce blood pressure.

EVA intervention: Behavioral: lifestyle counseling will be given according to international guidelines to reduce blood pressure. In contrast to BP arm, EVA arm will additionally reciuve counseling about vascular age.

Study summary

Cardiovascular diseases are the main cause of death worldwide and elevated blood pressure (BP), called hypertension (HTN), is the principal and most frequent factor for suffering cardiovascular diseases. Recent studies show that approximately five out of 10 adults in Europe have increased BP or will develop HTN in their life-course. Unfortunately, screening programs for establishing the diagnosis of HTN do not exist. As a result, almost half of hypertensive patients do not know that their BP is elevated. Regarding the other half of subjects, who have been already diagnosed of HTN and are aware of their condition, up to 50% of them are not adequately controlled, although successful treatment of HTN is possible. There are several reasons explaining why at the end only one quarter of the hypertensive population achieves normal BP values. Firstly, there is a lack of patients´ adherence to the prescribed treatment. In other words, many patients do not take their pills as ordered, mostly because they do not realize the health risks associated with HTN, as elevated BP does not hurt nor lead to clinical symptoms. As a matter of fact, many hypertensive patients do not comply with their prescribed treatments. Secondly, the mere fact of prescribing drugs for reducing elevated BP is very often considered enough by the treating general practitioners, not having into account that the target blood pressure values are not achieved. This attitude is called therapeutic inertia. And thirdly, there is a lack of efficient communication between those specialized groups of health professionals, which are involved in the management of HTN, i.e. general practitioners and community pharmacies. In the context of high BP, the concept of early vascular aging (EVA), presented roughly 10 years ago, has been widely adopted since. The concept of vascular age generally refers to a way of expressing cardiovascular risk as an estimated age, considered useful for improving the understanding of cardiovascular risk in patients, especially in young patients, in whom standard information about health risks, such as the classical 10 year-risk derived from risk tables, is low and may transmit a false reassuring perception. \"Your arteries are 15 years older then you\" seems to make vascular age intuitively understood even by lay people. Vascular age has been shown to be easily estimated in community pharmacies in different countries and may contribute to increase HTN control.

The goal of this clinical trial is to learn if increasing awareness of the consequences of elevated blood pressure by estimating vascular age of hypertensive patients in community pharmacies, and thus, empowering them, firstly, improves compliance with scheduled visits with general practitioners and secondly, increases hypertension control as measured by ambulatory blood pressure measurements (ABPM).

The main questions it aims to answer are:

* Do hypertensive patients who know their vascular age comply better with scheduled visits to their general practitioners than hypertensive patients not aware of their vascular age?
* Does knowledge of vascular age improve the proportion of controlled HTN according to ABPM measurements after six months of state of the art treatment? Researchers will compare two groups of hypertensive patients.
* One half of the patients, the BP-arm, will receive usual educational sessions and standard, optimized advice.
* The so-called EVA-arm will get the same educational sessions and advice, but on top will be informed about their vascular age. After six months, ABPM will be repeated in both groups.
* The study will take place in Austria, Portugal and Spain.

Participants:

* Participants are pharmacy customers who volunteered to participate.
* To enter the study, BP must be \> 140/90 mmHg in the pharmacy and \> 130/80 mmHg in the first ABPM.
* Recruitment and estimation of vascular age will take place in community pharmacies.
* Treatment will be established by the general physicians according to best clinical practice.
* The study will end after six months with a second measurement of ambulatory BP.

Eligibility

Primary outcome measure(s)

• Proportion of patients in the EVA cohort who do comply with the visit to the Primary Care Physician compared to the proportion of patients in the BP cohort who do comply with the visit to the Primary Care Physician. — Time between enrollment and diagnosis of hypertension in the community pharmacy and referral to the visit by the Primary Care Physician will be four weeks.
  Hypertensive patients will be randomized to the BP-cohort or the EVA-cohort. The hypothesis of the study is that the proportion of patients in the EVA-cohort who comply with the visit to the Primary Care Physician will be significantly higher than the proportion of patients in the BP-cohort who comply with the visit to the Primary Care Physician. Independent variables: Cohort \[BP/EVA\], Sex \[f/m\], Age \[years\], SBP \[mmHg\], DBP \[mmHg\], Smoker \[yes/no\], Heart rate \[beats/min\], Diabetes \[yes/no\], Obesity \[yes/no\], Pulse pressure (SBP - DBP) \[mmHg\], Prior CV event \[yes/no\]. In case of normal distribution of continuous variables but lack of variance homoscedasticity, Welch's t-test will be applied. For comparisons of continuous variables without normally distributed data and for comparisons of variables measured on ordinal scales, the Mann-Whitney U-test will be used. Dichotomous variables will be compared by the Fisher´s exact test, all other categorical variables by the chi-square test.
• Proportion of hypertensive patients in the EVA cohort who normalize blood pressure compared to the proportion of hypertensive patients in the BP cohort who normalize blood pressure as assessed by a second ABPM six months after the first ABPM. — Time between the first and the second ABPM will be six months
  Hypertensive patients will be randomized to the BP-cohort or the EVA-cohort. The hypothesis of the study is that patients in the EVA-cohort who normalize BP in the second ABPM will be significantly higher than the proportion of patients in the BP-cohort who normalize BP as assessed in the second ABPM. Normal ABPM means ABPM 24-h \< 130/80 mmHg. Independent variables: Cohort \[BP/EVA\], Sex \[f/m\], Age \[years\], SBP \[mmHg\], DBP \[mmHg\], Smoker \[yes/no\], Heart rate \[beats/min\], Diabetes \[yes/no\], Obesity \[yes/no\], Pulse pressure (SBP - DBP) \[mmHg\], Prior CV event \[yes/no\]. In case of normal distribution of continuous variables but lack of variance homoscedasticity, Welch's t-test will be applied. For comparisons of continuous variables without normally distributed data and for comparisons of variables measured on ordinal scales, the Mann-Whitney U-test will be used. Dichotomous variables will be compared by the Fisher´s exact test, all other categorical variables by the chi-square test.

Trial sites (6)