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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• PROMIS-29 v2.1 [Срок оценки: Baseline, 3 months, and 6 months after randomization]

Вторичные конечные точки (4)

• PAM-13 [Срок оценки: Baseline, 3 months, and 6 months.]
• MMHLQ [Срок оценки: Baseline, 3 months, and 6 months.]
• Number of emergency department visit [Срок оценки: Baseline, 3 months, and 6 months.]
• Hospitalizations [Срок оценки: Baseline, 3 months, and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Taipei Medical University — Taipei

Идентификаторы

NCT: NCT07577284 · N202603080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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