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

NCT07577284 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Cardiovascular Kidney Metabolic Syndrome

Interventions

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

Usual Care

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

Sponsors & Collaborators

  • Taipei Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-07-31
Completion
2029-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07577284 on ClinicalTrials.gov