AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2026
CompletedFirst Posted
Study publicly available on registry
May 11, 2026
CompletedStudy Start
First participant enrolled
May 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
May 11, 2026
May 1, 2026
1.2 years
April 23, 2026
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PROMIS-29 v2.1
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
Secondary Outcomes (4)
PAM-13
Baseline, 3 months, and 6 months.
MMHLQ
Baseline, 3 months, and 6 months.
Number of emergency department visit
Baseline, 3 months, and 6 months.
Hospitalizations
Baseline, 3 months, and 6 months
Study Arms (2)
AI chatbot-enabled nurse-led program
EXPERIMENTALControl group
OTHERUsual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
Interventions
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University
Taipei, No. 250號, Wuxing St, Xinyi District, Taipei City, 110, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors and data analysts are all blinded to group assignments.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 23, 2026
First Posted
May 11, 2026
Study Start
May 30, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2029
Last Updated
May 11, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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