Effectiveness of a multifactorial intervention, consisting of a self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs. The MEDICHY study

[eng] Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure. Methods/Design: This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales). Discussion: This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise). Abbreviations: ACC = American College of Cardiology, ACE = angiotensin-converting-enzyme, AHA = American Heart Association, ARB = Angiotensin II Receptor Blockers, BMI = body mass index, BP = blood pressure, BPSM = BP self-monitoring, CCB = calcium channel blocker, COPD = chronic obstructive pulmonary disease, CVR = cardiovascular risk, DASH = Dietary Approaches to Stop Hypertension, DBP = dyastolic blood pressure, ESC = European Society of Cardiology, ESH = European Society of Hypertension, FITT of exercise = frequency, intensity, time, and type, GP = general practitioner, IPAQ = International Physical activity Questionnaire, ITT = intention-to-treat, MPR = medication possession ratio, MTD = maximum tolerated dose, NNT = number needed to treat, NSAIDs = non-steroidal anti-inflammatory drugs, SBP = systolic blood pressure, VAS = visual analogue scale. Keywords: blood pressure control, hypertension, low sodium diet, physical exercise, self-management, self-monitorin

Effectiveness of a Multifactorial Intervention, Consisting of Self-Management of Antihypertensive Medication, Self-Measurement of Blood Pressure, Hypocaloric and Low Sodium Diet, and Physical Exercise, in Patients With Uncontrolled Hypertension Taking 2 or More Antihypertensive Drugs: The MEDICHY Study

[eng] Introduction: High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure. Methods/design: This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales). Discussion: This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise)