AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management for Early-Stage Cardiovascular-Kidney-Metabolic Syndrome

Keywords

• artificial intelligence
• cardiovascular-kidney-metabolic syndrome
• electronic patient-reported outcomes
• nurse-led care
• self-management

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Eligibility criteria

Study arms

• Experimental
  AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management

  Participants will receive usual outpatient care plus a 6-month AI chatbot-enabled ePRO monitoring and nurse-led self-management program, including weekly ePRO assessments, individualized feedback, self-management support, risk alerts, and nurse-led follow-up when indicated.

  Other: AI chatbot-enabled nurse-led program.

• Other
  Control group

  Participants will receive usual outpatient care and complete weekly ePRO assessments through a non-AI platform without automated feedback, individualized recommendations, risk alerts, or structured nurse-led support based on their weekly ePRO responses.

  Other: Usual Care

Interventions

• OtherAI chatbot-enabled nurse-led program.

  Participants 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.

• OtherUsual Care

  Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination

Primary outcomes

1. 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.

   Time frame: Baseline, 3 months, and 6 months

Secondary outcomes

1. 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.

   Time frame: Baseline, 3 months, and 6 months.

2. 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).

   Time frame: Baseline, 3 months, and 6 months.

3. 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.

   Time frame: Enrollment to 3 months and 3 months to 6 months

4. 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.

   Time frame: Baseline, 3 months, and 6 months

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be publicly shared due to ethical and privacy considerations. However, de-identified datasets may be made available to qualified researchers upon reasonable request after publication, subject to approval by the corresponding author and the Institutional Review Board (IRB) of Taipei Medical University. Data sharing will comply with institutional policies and applicable data protection regulations