This randomized controlled trial will evaluate the effectiveness of an AI chatbot-enabled electronic patient-reported outcome (ePRO) monitoring and nurse-led self-management intervention for adults with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. A total of 80 participants will be randomly assigned to either the intervention or control group and followed for 6 months. Participants in the intervention group will complete weekly ePRO assessments through an AI-enabled platform and receive individualized feedback, self-management support, and nurse-led clinical follow-up when indicated. Participants in the control group will receive usual care and complete weekly ePRO assessments through a non-AI platform without automated feedback or structured nurse-led support. Outcomes will be assessed at baseline, 3 months, and 6 months and will include patient-reported health outcomes, patient activation, health literacy, healthcare utilization, and changes in CKM syndrome stage.
Adults aged ≥40 years
Meet the criteria for stage 1 or stage 2 cardiovascular-kidney-metabolic (CKM) syndrome
Receive regular outpatient care at the study hospital
Able to communicate in Chinese
Meet the criteria for stage 3 or stage 4 CKM syndrome, including known subclinical cardiovascular disease, a stage 3 cardiovascular risk equivalent, or established clinical cardiovascular disease
Have kidney failure requiring chronic kidney replacement therapy
Have a terminal illness with a life expectancy of <6 months
Have cognitive impairment that, in the judgment of the treating physician or research team, precludes informed consent or meaningful participation in the intervention
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 Domain-Specific T-Scores and Pain Intensity
The PROMIS-29 v2.1 Traditional Chinese version will be used to assess seven health domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Each domain contains four items and will be scored separately and converted to standardized T-scores with a reference-population mean of 50 and standard deviation of 10. Higher T-scores indicate greater symptom burden for Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Interference, whereas higher T-scores indicate better health for Physical Function and Ability to Participate in Social Roles and Activities. Pain Intensity will be assessed separately using a single 0-10 numeric rating scale, with higher scores indicating greater pain intensity.
Patient Activation Measure-13 (PAM-13)
Patient activation will be assessed using the 13-item Patient Activation Measure (PAM-13), which evaluates individuals' knowledge, skills, and confidence in managing their health. Items are rated on a 5-point response scale, including a "not applicable" option. Raw scores are converted to a 0-100 scale, with higher scores indicating greater patient activation.
Mandarin Multidimensional Health Literacy Questionnaire (MMHLQ)
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 scale from very difficult to very easy. Scores are transformed to a 0-50 scale, with higher scores indicating better health literacy. Scores are categorized as insufficient (0-25), limited (\>25-33), sufficient (\>33-42), and excellent (\>42-50).
Healthcare Utilization
Healthcare utilization will be assessed prospectively based on participant self-report of the number of emergency department visits and hospitalizations occurring during each follow-up interval. Participants will also be encouraged to report such events through the study platform between scheduled assessments.
Change in CKM Syndrome Stage
CKM syndrome stage will be assessed using available clinical and laboratory information and participant-reported updates. Changes from baseline will be categorized as progression to a more advanced CKM syndrome stage or improvement to a lower stage.
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