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Effectiveness of an Artificial Intelligence Health Education Accurately Linking System (AI-HEALS) for the intervention of chronic kidney disease: a randomised controlled trial protocol

Year: 2026

Type: article

Abstract: Introduction Chronic kidney disease (CKD) is a major global health challenge with high morbidity and socioeconomic burden. Despite medical advances, long-term prognosis remains poor, highlighting the need for sustained self-management and health education. Traditional face-to-face care is limited by inefficient follow-up and insufficient attention to psychosocial and behavioural determinants, making it inadequate for long-term support. Artificial intelligence and mobile health offer personalised sustainable health education interventions. Accordingly, we developed the Artificial Intelligence Health Education Accurately Linking System (AI-HEALS) to support CKD self-management. Methods and analysis This is a single-centre, randomised, assessor-blinded, parallel-group controlled trial. A total of 74 adults with stages 1–5 CKD will be randomly allocated in a 1:1 ratio to either the control group, receiving standard care or the intervention group, receiving standard care plus the AI-HEALS programme for 3 months. The primary outcome is health-related quality of life, assessed using the physical component summary (PCS) score of the 12-item Short Form Health Survey (SF-12). The primary endpoint is the between-group difference in change in SF-12 PCS score from baseline to the end of the 3-month intervention. Secondary outcomes include serum creatinine levels, urinary protein creatinine ratio, anxiety, depression, quality of sleep, self-efficacy, dietary behaviour and eHealth literacy. Outcomes will be assessed at baseline, at the end of the intervention and at 3, 6 and 9 months after completion of the intervention. Linear mixed-effects models will be used to analyse repeated measurements over time. The findings of this study will provide evidence regarding the effectiveness of AI-HEALS in improving health-related quality of life and supporting self-management among patients with CKD. Ethics and dissemination This study protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (Ethics Approval Number: 2024–2106). The findings are expected to be disseminated through peer-reviewed journal publications, academic conference presentations and other forms of scholarly communication. Trial registration number ChiCTR2500099413.

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-120211