Arterial hypertension Circulatory System Hypertension
Conditions
Interventions
Usual clinical practice will be continued in patients assigned to the control group. The intervention to improve adherence to antihypertensive medications in the treatment group will include multi-lev
Sponsors
Osona Foundation for Research and Health Education (Fundació d?Osona per a la Recerca i l?Educació Sanitàries [FORES]) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 900 patients, aged 50 or older, presenting non-controlled systolic and/or diastolic hypertension, elevated cardiovascular risk (ten-year probability of a cardiovascular event =30%). 90 physicians from hospitals and primary care centers will be randomly allocated to the intervention or control group.
Exclusion criteria
Exclusion criteria: 1. Participation in any investigational clinical trial within the past 3 months. 2. Incapacity or unwillingness to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean SBP and DBP values obtained during office visit (measured at each visit with a semiautomatic sphygmomanometer (OMRON 705-CP). Main analysis will include blood pressure data until visit 3 (6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medication adherence according to MEMS (medication event monitoring system) device results. Medication adherence data will include information on the first 6 months (visit 3). Apart from recording the date and time each time the container is opened, the information from the electronic device may be downloaded to a computer for further statistical analysis. 2. Time elapsed until the first cardiovascular morbidity or mortality event during follow-up (expected follow-up duration: 5 years). 2.1. Fatal events ascribable to cardiovascular pathology. the following will be included: sudden heart failure; fatal myocardial infarction; death during/post percutaneous transluminal coronary angioplasty (PTCA) or aortocoronary bypass; death due to congestive heart failure; fatal CVA. 2.2. Non-fatal events ascribable to cardiovascular pathology. the following will be included: debutant congestive heart failure requiring hospitalization or chronic congestive heart failure requiring hospitalization; non-fatal acute myocardial infarction, as verified by a ST-segment peak in the ECG and/or typical enzyme pattern; emergency thrombolytic treatment/fibrinolytic treatment and/or emergency PTCA/aortocoronary bypass to prevent extensive myocardial infarction, as verified by a ST-segment peak in the ECG and/or typical enzyme pattern; CVA verified by CAT or hospital recordings; angina diagnosed with positive treadmill test results; routine PTCA/aortocoronary bypass; unstable angina requiring hospitalization; silent myocardial infarction detected during the study and not present in the ECGs prior to the beginning of the study; terminal renal insufficiency, impaired renal function. | — |
Countries
Spain
Outcome results
None listed