AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome
5 mai 2026 mis à jour par: Pei-Shan, Tsai, Taipei Medical University
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
72
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Pei Shan Tsai, PhD in Nursing
- Numéro de téléphone: 6300 +886 2 2736 1661
- E-mail: ptsai@tmu.edu.tw
Lieux d'étude
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No. 250號, Wuxing St, Xinyi District, Taipei City, 110
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Taipei, No. 250號, Wuxing St, Xinyi District, Taipei City, 110, Taïwan
- Taipei Medical University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: AI chatbot-enabled nurse-led program
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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.
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Autre: Control group
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
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Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PROMIS-29 v2.1
Délai: Baseline, 3 months, and 6 months after randomization
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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
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Baseline, 3 months, and 6 months after randomization
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PAM-13
Délai: Baseline, 3 months, and 6 months.
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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
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Baseline, 3 months, and 6 months.
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MMHLQ
Délai: Baseline, 3 months, and 6 months.
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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).
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Baseline, 3 months, and 6 months.
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Number of emergency department visit
Délai: Baseline, 3 months, and 6 months.
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the total count of times a patient visits the emergency department within a specified period during intervention program
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Baseline, 3 months, and 6 months.
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Hospitalizations
Délai: Baseline, 3 months, and 6 months
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The number of times a patient is admitted to a hospital within a specified period during intervention program
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Baseline, 3 months, and 6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 mai 2026
Achèvement primaire (Estimé)
31 juillet 2027
Achèvement de l'étude (Estimé)
31 juillet 2029
Dates d'inscription aux études
Première soumission
23 avril 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
11 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- N202603080
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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