AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Kidney Metabolic Syndrome
• Intervention / Treatment: Other: AI chatbot-enabled nurse-led program.; Other: Usual Care

Detailed Description

The trial is a two-arm, parallel-group randomized controlled study designed to evaluate an AI chatbot-enabled, nurse-led ePRO-based care model for individuals with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. A total of 72 adults aged 40 years and older will be recruited from three hospitals in Northern Taiwan and followed for six months. Participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group using a computer-generated block randomization sequence with concealed allocation. Due to the nature of the intervention, participant blinding is not possible; however, outcome assessors and data analysts will remain blinded.

The intervention group will receive a structured nurse-led program combined with an AI chatbot that delivers weekly PROMIS-29 symptom assessments, automated feedback, motivational self-management coaching, and risk-based alerts for clinical deterioration. Nurses will review alerts daily and provide tiered responses, including self-management guidance, teleconsultation, or referral to specialist care when necessary. The control group will receive standard care and weekly ePRO assessments without feedback or clinical integration.

Primary outcomes include symptom burden measured by PROMIS-29 v2.1, while secondary outcomes include patient activation, health literacy, and healthcare utilization (emergency visits and hospitalizations). Data will be collected at baseline, 3 months, and 6 months, and analyzed using linear mixed-effects models under an intention-to-treat framework. Safety monitoring will be continuous, with predefined clinical thresholds triggering automated alerts and nurse-led follow-up actions to ensure timely intervention and participant safety.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei Shan Tsai, PhD in Nursing; Phone Number: 6300 +886 2 2736 1661; Email: ptsai@tmu.edu.tw

Study Locations

• Taiwan
  • No. 250號, Wuxing St, Xinyi District, Taipei City, 110
    • Taipei, No. 250號, Wuxing St, Xinyi District, Taipei City, 110, Taiwan
      • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ≥40 years
• Classified as having stage CKM syndrome (stage 1-2)
• Receiving outpatient care
• Able to communicate in Mandarin/Taiwanese, and
• Having access to a smartphone/tablet

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI chatbot-enabled nurse-led program	Other: AI 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.
Other: Control group; Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination	Other: Usual Care; Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 3 months, and 6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 3 months, and 6 months.
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).	Baseline, 3 months, and 6 months.
Number of emergency department visit	the total count of times a patient visits the emergency department within a specified period during intervention program	Baseline, 3 months, and 6 months.
Hospitalizations	The number of times a patient is admitted to a hospital within a specified period during intervention program	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; artificial intelligence; patient activation; Chatbot; electronic patient-reported outcomes; cardiovascular kidney metabolic syndrome
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Patient Participation
• Other Study ID Numbers: N202603080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No