Pilot Randomised Controlled Trial Comparing Two Digital Solutions in the Management of Hypertensive Patients.

INTRODUCTION: Mobile health technologies may support hypertension management, yet comparative evidence between different digital platforms remains limited. AIM: This pilot randomized controlled trial aimed to compare the effectiveness, adherence, usability and patient satisfaction of two m-health solutions versus standard care on blood pressure (BP) control in patients with hypertension. METHODS: In this open-label, single-centre pilot trial, adults with essential hypertension were randomised (1:1:1) to standard care, Digital Solution 1 (DS1) or Digital Solution 2 (DS2). Both digital interventions enabled home BP and body weight monitoring via connected devices and smartphone applications. The primary endpoint was the difference in office BP change from baseline to 6 months among groups, analyzed using linear mixed models. Secondary endpoints included changes in body weight, adherence to home BP and weight monitoring, and patient-reported usability and satisfaction. Quality of life and physical activity were assessed as exploratory outcomes. RESULTS: A total of 65 patients were included and randomized whilst 49 completed the 6-month follow-up. No significant between-group differences at this time were observed in office systolic or diastolic BP trends (interaction p=0.44 and p=0.22, respectively). Adherence to home BP monitoring was higher with DS2 than DS1 (median adherent weeks 71% vs 11%, p=0.0002). Similarly, adherence to body weight monitoring was greater with DS2 (median 43% vs 11% of weeks, p=0.007). DS2 was also associated with higher usability and satisfaction scores. No significant differences were observed in body weight change, quality of life or physical activity. CONCLUSION: In this pilot study, m-health interventions did not improve office BP control compared with standard care. However, marked differences in adherence and usability between digital platforms were observed, underscoring the importance of system design and user experience in determining the effectiveness of digital strategies for hypertension management.