AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI chatbot-enabled nurse-led program., Usual Care.
- Who it may be relevant to
- Registry conditions: Cardiovascular Kidney Metabolic Syndrome. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other 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 - Other Usual Care
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
Primary outcome measures
- PROMIS-29 v2.1 [Time frame: Baseline, 3 months, and 6 months after randomization]
Secondary outcome measures (4)
- PAM-13 [Time frame: Baseline, 3 months, and 6 months.]
- MMHLQ [Time frame: Baseline, 3 months, and 6 months.]
- Number of emergency department visit [Time frame: Baseline, 3 months, and 6 months.]
- Hospitalizations [Time frame: Baseline, 3 months, and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Taipei Medical University — Taipei
Identifiers
NCT: NCT07577284 · N202603080