This randomized clinical trial aims to evaluate whether an AI chatbot-enabled, nurse-led electronic patient-reported outcome (ePRO) intervention can improve symptom management and self-care in adults with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. The study will also assess the safety and feasibility of the intervention. Researchers will investigate whether the program reduces symptom burden, improves patient activation and health literacy, and lowers healthcare utilization such as emergency department visits and hospitalizations compared with usual ePRO monitoring alone. A total of 72 participants will be randomly assigned to either an intervention group, which receives weekly AI chatbot-supported symptom monitoring combined with nurse-led feedback and self-management support, or a control group receiving ePRO monitoring without feedback. Participants will complete PROMIS-29 assessments weekly and attend study evaluations at baseline, 3 months, and 6 months, while clinical outcomes and healthcare use are tracked through electronic medical records.
Adults ≥40 years
Classified as having stage CKM syndrome (stage 1-2)
Receiving outpatient care
Able to communicate in Mandarin/Taiwanese, and
End-stage kidney disease requiring dialysis or are listed for kidney transplantation
Have terminal illness (<6 months life expectancy)
Have significant cognitive impairment
Currently enrolled in another interventional study targeting cardiovascular-kidney-metabolic syndrome or multimorbidity
Parallel
AI chatbot-enabled nurse-led program.
Other interventionParticipants in the intervention group will receive a six-month nurse-led, AI chatbot-enabled symptom monitoring and self-management program integrating weekly ePRO assessments. The intervention begins with a structured nurse-led intake session including CKM assessment, symptom review, goal setting, and training on chatbot use. Participants complete weekly PROMIS-29 v2.1 assessments via a smartphone-based chatbot, which provides automated, rule-based feedback, self-management guidance, and motivational prompts. A risk-stratification algorithm generates alerts when symptom deterioration is detected. Nurses review alerts daily and provide follow-up via messaging, teleconsultation, or referral depending on severity, with same-day escalation for high-risk symptoms.
Usual Care
Other interventionUsual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
PROMIS-29 v2.1
Symptom burden will be evaluated using the PROMIS-29 v2.1 Traditional Chinese version (31). This instrument comprises 29 items across seven domains: Physical Function, Depression, Anxiety, Fatigue, Sleep Disturbance, Social Participation, and Pain (Intensity and Interference). Most items are rated on a 5-point Likert scale (1-5), with a single pain intensity item scored from 0 to 10. Domain scores are summed and converted to standardized T-scores ranging from 0 to 100, with higher scores indicating greater symptom severity
PAM-13
Patient activation (PAM-13), which evaluates individuals' knowledge, skills, and confidence in managing their health. Items are rated on a 5-point Likert scale (from strongly disagree to strongly agree, with an additional "not applicable" option). Raw scores are converted using standardized calibration tables to a 0-100 scale, with higher scores indicating greater activation
MMHLQ
Health literacy will be assessed using the 20-item Mandarin Multidimensional Health Literacy Questionnaire. Health literacy will be assessed using the 20-item Mandarin Multidimensional Health Literacy Questionnaire (MMHLQ), which covers five domains: obtaining, understanding, evaluating, and applying health information, as well as communication and interaction. Each item is rated on a 4-point Likert scale ranging from very difficult to very easy. Scores are transformed to a 0-50 scale using the formula (Mean - 1) × (50/3), with higher scores indicating better health literacy. Levels are categorized as insufficient (0-25), limited (25-33), sufficient (33-42), and excellent (42-50).
Number of emergency department visit
the total count of times a patient visits the emergency department within a specified period during intervention program
Hospitalizations
The number of times a patient is admitted to a hospital within a specified period during intervention program
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