NCT06761235Toborzás még nem indult
Knowledge of Vascular Age Contributes to Improve the Collaboration Between Community Pharmacies and Primary Health Care Physicians in Reducing Blood Pressure in Hypertensive Patients.
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jan. 7. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1246 (tervezett)
- Első benyújtás
- 2024. nov. 17.
- Kezdés
- 2025. febr. 1.
- Elsődleges befejezés
- 2026. nov. 1.
- Fő szponzor
- Enrique Rodilla
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT06761235
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 1246
- 2025. febr. 1. és az elsődleges befejezés (2026. nov. 1.) között
- 6 helyszín, 3 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Previous measurement of VA in the last year
Más betegség
- Factors preventing the correct measurement of BP/VA (arrhythmias, arm circumference, etc.)
Egyéb
- Pregnancy
- Inability to understand the project (language barrier)
- Manifest incapacity or knowledge of the existence of a legal representative
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Austrian Chamber of Pharmacists, Upper Austria (APO) | Linz | Ausztria | Ismeretlen állapot |
| Upper Austrian Society for General and Family Medicine (OBGAM) | Linz | Ausztria | Ismeretlen állapot |
| Instituto Pluridisciplinar, Universidad Complutense de Madrid | Madrid | Spanyolország | Ismeretlen állapot |
| Hospital de Sagunto | Sagunto (valencia) | Spanyolország | Ismeretlen állapot |
| Unidad de investigación de Atención Primaria de Salamanca (APISAL). Instituto de Investigación Biomédica de Salamanca (IBSAL) | Salamanca | Spanyolország | Ismeretlen állapot |
| H&TRC - Health & Technology Research Center, Coimbra Health School, Polytechnic University of Coimbra | Coimbra | Portugália | Ismeretlen állapot |
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