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NCT Number: NCT07577284

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.

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Key information

Conditions

Cardiovascular Kidney Metabolic Syndrome Behavior Health Behavior Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI chatbot-enabled nurse-led program.

Other

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.

Usual Care

Other

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

    Time frame: Baseline, 3 months, and 6 months after randomization

    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

Secondary outcomes

  1. PAM-13

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

    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

  2. MMHLQ

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

    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).

  3. Number of emergency department visit

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

    the total count of times a patient visits the emergency department within a specified period during intervention program

  4. Hospitalizations

    Time frame: Baseline, 3 months, and 6 months

    The number of times a patient is admitted to a hospital within a specified period during intervention program

Study contacts

Contact information is provided by the study sponsor or research team.

Pei Shan Tsai, PhD in Nursing

CONTACT

[email protected]

+886 2 2736 1661 ext. 6300

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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