Abstract
BACKGROUND: Chatbots can provide immediate assistance tailored to patients' needs, making them suitable for sustained accompanying interventions. Nevertheless, there is currently no evidence regarding their acceptability by hypertensive patients and the factors influencing the acceptability in the real-world. Existing evaluation scales often focus solely on the technology itself, overlooking the patients' perspective. Utilizing mixed methods can offer a more comprehensive exploration of influencing factors, laying the groundwork for the future integration of artificial intelligence in chronic disease management practices. METHODS: The mixed methods will provide a holistic view to understand the effectiveness and acceptability of the intervention. Participants will either receive the standard primary health care or obtain a chatbot speaker. The speaker can provide timely reminders, on-demand consultations, personalized data recording, knowledge broadcasts, as well as entertainment features such as telling jokes. The quantitative part will be conducted as a quasi-randomized controlled trial in community in Beijing. And the convergent design will be adopted. When patients use the speaker for 1 month, scales will be used to measure patients' intention to use the speaker. At the same time, semi-structured interviews will be conducted to explore patients' feelings and influencing factors of using speakers. Data on socio-demography, physical examination, blood pressure, acceptability and self-management behavior will be collected at baseline, as well as 1,3,6, and 12 months later. Furthermore, the cloud database will continuously collect patients' interactions with the speaker. The primary outcome is the efficacy of the chatbot on blood pressure control. The secondary outcome includes the acceptability of the chatbot speaker and the changes of self-management behavior. DISCUSSION: Artificial intelligence-based chatbot speaker not only caters to patients' self-management needs at home but also effectively organizes intricate and detailed knowledge system for patients with hypertension through a knowledge graph. Patients can promptly access information that aligns with their specific requirements, promoting proactive self-management and playing a crucial role in disease management. This study will serve as a foundation for the application of artificial intelligence technology in chronic disease management, paving the way for further exploration on enhancing the communicative impact of artificial intelligence technology. TRIAL REGISTRATION: Biomedical Ethics Committee of Peking University: IRB00001052-21106, 2021/10/14; Clinical Trials: ChiCTR2100050578, 2021/08/29.