An intervention study on the secondary prevention medication adherence of ischemic stroke patients based on the protection motivation theory combined with medication literacy education in the AI-HEALS: a randomized controlled trial protocol

Background: This study aims to improve medication adherence in ischemic stroke (IS) patients using a dual-driven motivation-competence intervention framework based on the theory of protective motivation (PMT) and the medication literacy model. Therefore, this study used the WeChat platform as the intervention vehicle and innovatively introduced the AI-HEALS, including the AI intelligent question and answer system and the HEALS (Health Education Accurately Linking System), aiming to achieve personalised intervention through the intelligent terminal. Methods: The study will conduct a single-blind, single-centre randomised controlled trial in Linyi City Central Hospital, Shandong Province, with IS patients over 18 years old. The intervention group will receive routine care combined with the AI-HEALS, while the control group will receive routine care alone. Primary outcomes include changes in medication adherence levels at baseline and 1, 3, and 6 months of follow-up. Secondary outcomes encompass medication behavior management, medication literacy, self-efficacy, social cognition, psychological levels, and clinical outcome indicators. Discussion: The aim of this study was to develop an intervention programme for secondary prevention medication adherence in patients with IS by combining PMT and medication literacy models and using the AI-HEALS. Although PMT has shown effectiveness in improving health behaviors in patients with chronic diseases, systematic studies of its application to stroke patients are lacking. Our intervention framework aims to stimulate motivation, develop competence, and solidify behaviors to overcome the limitations of a single theory in complex medication scenarios. The AI-HEALS addresses the challenges of traditional mHealth interventions and is expected to improve patients' medication literacy and adherence through precise knowledge push, dynamic interaction support, and full-cycle management. The development of the AI-HEALS helps to reduce the burden on healthcare professionals, improve the distribution of healthcare resources, and have potential health economics benefits. Clinical trial registration: https://www.chictr.org.cn, ChiCTR2500101457.