AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome
5 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
72
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Pei Shan Tsai, PhD in Nursing
- Número de teléfono: 6300 +886 2 2736 1661
- Correo electrónico: ptsai@tmu.edu.tw
Ubicaciones de estudio
-
-
No. 250號, Wuxing St, Xinyi District, Taipei City, 110
-
Taipei, No. 250號, Wuxing St, Xinyi District, Taipei City, 110, Taiwán
- Taipei Medical University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Otro: Control group
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
|
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PROMIS-29 v2.1
Periodo de tiempo: 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
|
Baseline, 3 months, and 6 months after randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PAM-13
Periodo de tiempo: 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
|
Baseline, 3 months, and 6 months.
|
|
MMHLQ
Periodo de tiempo: 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).
|
Baseline, 3 months, and 6 months.
|
|
Number of emergency department visit
Periodo de tiempo: Baseline, 3 months, and 6 months.
|
the total count of times a patient visits the emergency department within a specified period during intervention program
|
Baseline, 3 months, and 6 months.
|
|
Hospitalizations
Periodo de tiempo: Baseline, 3 months, and 6 months
|
The number of times a patient is admitted to a hospital within a specified period during intervention program
|
Baseline, 3 months, and 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de mayo de 2026
Finalización primaria (Estimado)
31 de julio de 2027
Finalización del estudio (Estimado)
31 de julio de 2029
Fechas de registro del estudio
Enviado por primera vez
23 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
11 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- N202603080
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .