Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: A Pilot Open‐Label Randomized Controlled Trial

The aim of this pilot study was to test the feasibility of a clinical trial to evaluate the impact of an advanced practice nurse (APN) intervention on blood pressure (BP) control versus usual care in hypertension management, and to provide initial trends. This pilot study was designed as a prospective, open-label, randomized 1:1, controlled, and monocentric superiority trial, conducted in a French-labeled European Society of Hypertension excellence center. The APN intervention consisted of an in-depth therapeutic education and an assessment of therapeutic strategies with adjustments if needed. The study sample included 437 participants (n = 229 in the experimental group; n = 208 in the "usual care" group). Considering the selection bias identified for baseline systolic BP, statistical analyses were adjusted on this parameter. The APN intervention significantly reduced adjusted systolic BP in the experimental group compared with the "usual care" group (-2.72 mm Hg, p = 0.04) and showed a trend toward a decrease in adjusted diastolic BP (-1.85 mm Hg, p = 0.07) and improved BP control with the APN intervention (-8.5%, p = 0.08). The experimental group was significantly more likely to adhere to the HBPM protocol compared with the control group (OR = 1.82, 95% CI [1.22-2.71], p = 0.003). This pilot study confirmed the feasibility of the clinical trial and offered the first data about APNs in hypertension management in France. Initial significant or borderline significant results are encouraging and suggest the benefit of an APN intervention on BP control in hypertension management. Further studies are needed to confirm these results. Trial registration: This clinical trial was registered on ClinicalTrials platform (NCT06227884).