CURATE.AI-Assisted Dose titration for Anti-hypertensive Personalised Therapy (CURATE.AI-ADAPT): Study protocol for a multi-arm, randomised, pilot feasibility trial using CURATE.AI

Abstract Aims Artificial intelligence-driven small data platforms, such as CURATE.AI, hold potential for personalised hypertension care by assisting physicians in identifying personalised anti-hypertensive doses for titration. This trial aims to assess the feasibility of a larger randomised controlled trial (RCT) evaluating the efficacy of CURATE.AI-assisted dose titration intervention. We will also collect preliminary efficacy and safety data, and explore stakeholder feedback in the early design process. Methods In this open-label, randomised, pilot feasibility trial, we aim to recruit 45 participants with primary hypertension. Participants will be randomised in 1:1:1 ratio into control (no intervention), home blood pressure monitoring (active control; HBPM), or CURATE.AI arms (intervention; HBPM and CURATE.AI-assisted dose titration). The home treatments include one month of two-drug anti-hypertensive regimens. Primary endpoints assess the logistical (e.g. dose adherence) and scientific (e.g. percentage of participants for which CURATE.AI profiles can be generated) feasibility, and define the progression criteria for the RCT in a ‘traffic light system’. Secondary endpoints assess preliminary efficacy (e.g. mean change in office BPs), and safety (e.g. hospitalisation events) associated with each treatment protocol. Participants with both baseline and post-treatment BP measurements will form the intent-to-treat analysis. Following their involvement with the CURATE.AI intervention, feedback from CURATE.AI participants and healthcare providers will be collected via exit survey and interviews. Conclusion Findings from this study will inform on potential refinements of the current treatment protocols before proceeding with a larger RCT, or potential expansion to collect additional information. Positive results may suggest the potential efficacy of CURATE.AI to improve BP control. Trial registration number NCT05376683