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) versus 142.7 mmHg (+/- 15.0), adjusted mean difference 8.7 mmHg (95% CI 3.4 to 13.9), p < 0.001) and a significantly lower diastolic blood pressure (83.5 mmHg (+/- 8.8) versus 87.00 mmHg (+/- 9.0), adjusted mean difference 5.4 (95% CI 2.9 to 7.8), p < 0.0001). The intervention group also had significantly more patients who achieved successful blood pressure control (< 140/90 mmHg; 54.4% versus 32.9%, p = 0.011). DISCUSSIONS: 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.

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