CURATE.AI-assisted dose titration for anti-hypertensive personalized therapy: study protocol for a multi-arm, randomized, pilot feasibility trial using CURATE.AI (CURATE.AI ADAPT trial)

作者：Anh T. L. Truong, Shi‐Bei Tan, Golda Z Wang, Alexander W J Yip, Mathias Egermark, Wesley Yeung, V Vien Lee, Mark Y Chan, Kirthika Senthil Kumar, Lester W. J. Tan, S Vijayakumar, Agata Blasiak, Laureen Yi-Ting Wang, Dean Ho · 发表于：European Heart Journal - Digital Health · 年份：2023 · DOI：10.1093/ehjdh/ztad063 · 被引用次数：21 · 研究领域：Artificial Intelligence in Healthcare and Education、Blood Pressure and Hypertension Studies、Health, Environment, Cognitive Aging

Aims: Artificial intelligence-driven small data platforms such as CURATE.AI hold potential for personalized hypertension care by assisting physicians in identifying personalized anti-hypertensive doses for titration. This trial aims to assess the feasibility of a larger randomized 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 and results: In this open-label, randomized, pilot feasibility trial, we aim to recruit 45 participants with primary hypertension. Participants will be randomized 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 1 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 blood pressures (BPs)] and safety (e.g. hospitalization 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 ...