Effectiveness of medication self-management, self-monitoring and a lifestyle intervention on hypertension in poorly controlled patients: The MEDICHY randomized trial.

Background: Uncontrolled hypertension is a common problem worldwide, despite the availability of many effective antihypertensive drugs and lifestyle interventions. We assessed the efficacy of a multi-component intervention in individuals with uncontrolled hypertension in a primary care setting. Methods: This study was a randomized, multicenter, parallel, two-arm, single-blind controlled trial performed in primary healthcare centers in Mallorca (Spain). All participants were 35 to 75-years-old and had poorly controlled hypertension. Patients were randomly assigned in a 1:1 ratio to a control group (usual care) or an intervention group (self-monitoring of blood pressure, self-titration of hypertensive medications, dietary interventions, and physical activity interventions). The primary outcome was decrease in the mean SBP at 6 months relative to baseline. Results: A total of 153 participants were randomized to an intervention group (77) or a control group (76). After 6 months, the intervention group had a significantly lower systolic blood pressure (135.1 mmHg [±14.8] vs. 142.7 mmHg [±15.0], adjusted mean difference: 8.7 mmHg [95% CI: 3.4, 13.9], p < 0.001) and a significantly lower diastolic blood pressure (83.5 mmHg [±8.8] vs. 87.00 mmHg [±9.0], adjusted mean difference: 5.4 [95% CI: 2.9, 7.8], p < 0.0001). The intervention group also had significantly more patients who achieved successful blood pressure control (<140/90 mmHg; 54.4% vs. 32.9%, p = 0.011). Discussion: Self-monitoring of blood pressure in combination with self-management of hypertensive medications, diet, and physical activity in a primary care setting leads to significantly lower blood pressure in patients with poorly controlled hypertension.Clinical Trial Registration: ClinicalTrials.gov, identifier ISRCTN14433778.

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.

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).