Vascular Age As a Key for a Team-based Approach to Manage Blood Pressure Bridging Community Pharmacists and Primary Health Care Physicians - the TOGETHER Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,246
- 试验地点
- 12
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
The five challenges in controlling high blood pressure Poor control of Hypertension and absence of sustained screening strategies Cardiovascular (CV) diseases represent the principal cause of death in Europe with 343.4 deaths/100,000 inhabitants, clearly ahead cancer with 235.3 deaths/100,000 inhabitants/year in 2021. Within the three different countries participating in TOGETHER, Austria (AT), Portugal (PT) and Spain (ES), AT ranks first with 343.3 CV deaths/100,000 inhabitants/year, followed by PT and ES, with 247.9 and 213.0 CV deaths/100.000 inhabitants/year, respectively1.
High blood pressure (BP), known as arterial hypertension (HTN), is the leading risk factor for CV diseases and hence for disability and mortality worldwide. According to a recent review of 12 western countries showed prevalence rates between 33% and 56%, knowledge rates between 46% and 84%, treatment rates between 39% and 81% and control rates between 17% and 69%.
Unfortunately, reliable data on prevalence and treatment of HTN in the three participating countries are scarce. In May 2017, as part of the International Society of Hypertension (ISH) "May Measurement Month"-campaign, standardized BP measurements were conducted in 80 countries around the world in various locations. In AT, 56 centers participated in the initiative and a total of 2,711 people were screened for HTN. Of these, 1,704 (62.9%) had BP values > 140/90 mmHg. Participants were also provided with comorbidities and medication assessment sheets, which showed that 43.2% of subjects without antihypertensive treatment were hypertensive. The result for people who were already taking antihypertensive therapy was particularly worrying as 63.5% had uncontrolled HTN.
The results of the same MMM-2017-campaign in ES were similar. 7,646 subjects participated throughout ES, 40.0% presented with HTN, of which 74.4% were aware of their disease, while up to 25.6% of patients with high BP levels were unaware of their HTN status. Among participants who were not taking antihypertensive drugs, elevated values were measured in 16.9%. Another worrying finding is that in treated hypertensive patients, 36.4% had not controlled values.
In PT, the prevalence of HTN in the adult population was estimated to be 42.2% in the PHYSA study, a representative sample of the 18-90-year-old population, including 3,720 participants, with 70% of the HTN patients under pharmacological medication. The age-specific prevalence of hypertension was 6.8, 46.9 and 74.9% in people below 35 years, 35-64 years and above 64 years, and overall, among the hypertensive patients, 76.6% were aware of the HTN condition, 74.9% were treated but only 42.5% were controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
No other parties masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •BP ≥ 140 mmHg and/or ≥ 90 mmHg in the pharmacy
- •24-hour ABPM ≥ 130 mmHg or ≥ 80 mmHg
- •Willingness to fill in forms, regarding
- •Anamnesis (DM, hypercholesterolemia)
- •Toxic habits
- •Pharmacological groups of CV medication
- •Previous CV diseases
- •Data on GP and assigned Health Center
- •Survey regarding interaction with GP and community pharmacist
排除标准
- •Pregnancy
- •Inability to understand the project (language barrier)
- •Manifest incapacity or knowledge of the existence of a legal representative
- •Factors preventing the correct measurement of BP/VA (arrhythmias, arm circumference, etc.)
- •Previous measurement of VA in the last year
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
次要结局
- Change in proportion of smokers who quit smoking.(Six months.)
- Change of 5 mmHg in systolic blood pressure and/or of 2 mmHg in diastolic blood pressure in the second ABPM(Six months between first and second ABPM.)
- Changes in lipid metabolism of cholesterol-LDL towards normalization.(Six months.)
- Change of body mass index (BMI) from obesity towards overweight or normal weight.(Six months.)
- Changes in the score of collaborative surveys between Pharmacists and Primary Care Physicians.(Six months.)
- Changes in vascular risk stratification.(Six months.)
- Change in scores measuring adherence with prescribed antihypertensive treatment.(Six months.)
研究者
Enrique Rodilla
PhD, full Professor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana