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