Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

AIM: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. PATIENTS & METHODS: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. RESULTS: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5-145.4 mmHg) among all study participants. CONCLUSION: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. CLINICAL TRIAL REGISTRATION: NCT00139490.