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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Start date: May 30, 2026 to Oct 1, 2026
    • Enrollment increased: 72 → 80 participants
    • Eligibility criteria expanded, about 90 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 19 words
    • Study title revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07577284
Lead Sponsor Taipei Medical University
Conditions
(from sponsor)		 Cardiovascular-kidney-metabolic Syndrome
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov