Cardiovascular-kidney-metabolic SyndromeNCT07577284
AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management for Early-Stage Cardiovascular-Kidney-Metabolic Syndrome
A study testing AI chatbot-enabled nurse-led program. in people with Cardiovascular-kidney-metabolic Syndrome, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This randomized controlled trial will evaluate the effectiveness of an AI chatbot-enabled electronic patient-reported outcome (ePRO) monitoring and nurse-led self-management intervention for adults with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular-kidney-metabolic Syndrome
- What is being tested?
- AI chatbot-enabled nurse-led program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥40 years
- Meet the criteria for stage 1 or stage 2 cardiovascular-kidney-metabolic (CKM) syndrome
- Receive regular outpatient care at the study hospital
- Able to communicate in Chinese
- Able to provide written informed consent and complete the required study assessments
- Have access to a smartphone or tablet compatible with the study ePRO platform
Who cannot join
- Meet the criteria for stage 3 or stage 4 CKM syndrome, including known subclinical cardiovascular disease, a stage 3 cardiovascular risk equivalent, or established clinical cardiovascular disease
- Have kidney failure requiring chronic kidney replacement therapy
- Have a terminal illness with a life expectancy of <6 months
- Have cognitive impairment that, in the judgment of the treating physician or research team, precludes informed consent or meaningful participation in the intervention
- Are currently participating in another interventional study that could substantially influence the study outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University
Taipei, No. 250號, Wuxing St, Xinyi District, Taipei City, 110
About this study
Official title: AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management for Early-Stage Cardiovascular-Kidney-Metabolic Syndrome: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effectiveness of an AI chatbot-enabled electronic patient-reported outcome (ePRO) monitoring and nurse-led self-management intervention for adults with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. A total of 80 participants will be randomly assigned to either the intervention or control group and followed for 6 months. Participants in the intervention group will complete weekly ePRO assessments through an AI-enabled platform and receive individualized feedback, self-management support, and nurse-led clinical follow-up when indicated. Participants in the control group will receive usual care and complete weekly ePRO assessments through a non-AI platform without automated feedback or structured nurse-led support. Outcomes will be assessed at baseline, 3 months, and 6 months and will include patient-reported health outcomes, patient activation, health literacy, healthcare utilization, and changes in CKM syndrome stage.
Read the detailed description
This two-arm, parallel-group randomized controlled trial will evaluate the effectiveness of an AI chatbot-enabled electronic patient-reported outcome (ePRO) monitoring and nurse-led self-management intervention for adults with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. A total of 80 adults aged 40 years or older with stage 1 or stage 2 CKM syndrome will be recruited from one tertiary hospital in Northern Taiwan and followed for 6 months. Participants will be randomly assigned in a 1:1 ratio using computer-generated permuted block randomization with randomly varying block sizes of 4 and 6 and allocation concealment.
Participants in the intervention group will receive usual outpatient care plus an AI chatbot-enabled ePRO monitoring and nurse-led self-management intervention. The AI-enabled platform will support weekly ePRO monitoring, individualized feedback, self-management support, and risk identification. Nurses will review clinically significant alerts and provide individualized support, care coordination, and clinical escalation when indicated.
Participants in the control group will receive usual outpatient care and complete weekly ePRO assessments through a non-AI platform without automated feedback, individualized recommendations, risk alerts, or nurse-led follow-up based on their weekly ePRO responses.
Primary outcomes include the seven PROMIS-29 domain-specific T-scores and the 0-10 Pain Intensity score. Secondary outcomes include patient activation, health literacy, healthcare utilization, and changes in CKM syndrome stage. Patient-reported health outcomes, patient activation, health literacy, and CKM syndrome stage will be assessed at baseline, 3 months, and 6 months, while healthcare utilization will be assessed prospectively over the 6-month follow-up period, with data collected at 3 and 6 months and updated through interim participant reports.
- Conditions
- Cardiovascular-kidney-metabolic Syndrome
- Being tested
- AI chatbot-enabled nurse-led program., Usual Care
- Keywords
- artificial intelligence, cardiovascular-kidney-metabolic syndrome, electronic patient-reported outcomes, nurse-led care, self-management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI chatbot-enabled nurse-led program.Other
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.
Usual CareOther
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
| Study group | Role | What they receive |
|---|---|---|
| AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management | Experimental | Participants will receive usual outpatient care plus a 6-month AI chatbot-enabled ePRO monitoring and nurse-led self-management program, including weekly ePRO assessments, individualized feedback, self-management support, risk alerts, and nurse-led follow-up when indicated. Receives: Other: AI chatbot-enabled nurse-led program. |
| Control group | Other | Participants will receive usual outpatient care and complete weekly ePRO assessments through a non-AI platform without automated feedback, individualized recommendations, risk alerts, or structured nurse-led support based on their weekly ePRO responses. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS-29 v2.1 Domain-Specific T-Scores and Pain Intensity
The PROMIS-29 v2.1 Traditional Chinese version will be used to assess seven health domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Each domain contains four items and will be scored separately and converted to standardized T-scores with a reference-population mean of 50 and standard deviation of 10. Higher T-scores indicate greater symptom burden for Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Interference, whereas higher T-scores indicate better health for Physical Function and Ability to Participate in Social Roles and Activities. Pain Intensity will be assessed separately using a single 0-10 numeric rating scale, with higher scores indicating greater pain intensity.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (4)
Patient Activation Measure-13 (PAM-13)
Patient activation will be assessed using the 13-item Patient Activation Measure (PAM-13), which evaluates individuals' knowledge, skills, and confidence in managing their health. Items are rated on a 5-point response scale, including a "not applicable" option. Raw scores are converted to a 0-100 scale, with higher scores indicating greater patient activation.
Measured: Baseline, 3 months, and 6 months.
Mandarin Multidimensional Health Literacy Questionnaire (MMHLQ)
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 scale from very difficult to very easy. Scores are transformed to a 0-50 scale, with higher scores indicating better health literacy. Scores are categorized as insufficient (0-25), limited (>25-33), sufficient (>33-42), and excellent (>42-50).
Measured: Baseline, 3 months, and 6 months.
Healthcare Utilization
Healthcare utilization will be assessed prospectively based on participant self-report of the number of emergency department visits and hospitalizations occurring during each follow-up interval. Participants will also be encouraged to report such events through the study platform between scheduled assessments.
Measured: Enrollment to 3 months and 3 months to 6 months
Change in CKM Syndrome Stage
CKM syndrome stage will be assessed using available clinical and laboratory information and participant-reported updates. Changes from baseline will be categorized as progression to a more advanced CKM syndrome stage or improvement to a lower stage.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular-kidney-metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the intervention arm will receive a 6-month AI chatbot-enabled, nurse-led ePRO monitoring and self-management program in addition to usual outpatient care. The AI chatbot will deliver weekly PROMIS-29 ePRO assessments and provide individualized feedback and self-management support based on prespecified decision rules. Clinically relevant symptom deterioration may trigger alerts for nurse review, with individualized support, care coordination, or clinical escalation provided when indicated. The AI chatbot will function as a decision-support and self-management tool and will not replace professional clinical judgment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Shan, Tsai, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577284
- Sponsor's protocol ID
- N202603080
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management for Early-Stage Cardiovascular-Kidney-Metabolic Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07577284
- Acronym / sponsor ID
- N202603080
- Conditions
- Cardiovascular-kidney-metabolic Syndrome
- Keywords
- artificial intelligence, cardiovascular-kidney-metabolic syndrome, electronic patient-reported outcomes, nurse-led care, self-management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will evaluate the effectiveness of an AI chatbot-enabled electronic patient-reported outcome (ePRO) monitoring and nurse-led self-management intervention for adults with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. A total of 80 participants will be randomly assigned to either the intervention or control group and followed for 6 months. Participants in the intervention group will complete weekly ePRO assessments through an AI-enabled platform and receive individualized feedback, self-management support, and nurse-led clinical follow-up when indicated. Participants in the control group will receive usual care and complete weekly ePRO assessments through a non-AI platform without automated feedback or structured nurse-led support. Outcomes will be assessed at baseline, 3 months, and 6 months and will include patient-reported health outcomes, patient activation, health literacy, healthcare utilization, and changes in CKM syndrome stage.
Detailed description
This two-arm, parallel-group randomized controlled trial will evaluate the effectiveness of an AI chatbot-enabled electronic patient-reported outcome (ePRO) monitoring and nurse-led self-management intervention for adults with early-stage cardiovascular-kidney-metabolic (CKM) syndrome. A total of 80 adults aged 40 years or older with stage 1 or stage 2 CKM syndrome will be recruited from one tertiary hospital in Northern Taiwan and followed for 6 months. Participants will be randomly assigned in a 1:1 ratio using computer-generated permuted block randomization with randomly varying block sizes of 4 and 6 and allocation concealment.
Participants in the intervention group will receive usual outpatient care plus an AI chatbot-enabled ePRO monitoring and nurse-led self-management intervention. The AI-enabled platform will support weekly ePRO monitoring, individualized feedback, self-management support, and risk identification. Nurses will review clinically significant alerts and provide individualized support, care coordination, and clinical escalation when indicated.
Participants in the control group will receive usual outpatient care and complete weekly ePRO assessments through a non-AI platform without automated feedback, individualized recommendations, risk alerts, or nurse-led follow-up based on their weekly ePRO responses.
Primary outcomes include the seven PROMIS-29 domain-specific T-scores and the 0-10 Pain Intensity score. Secondary outcomes include patient activation, health literacy, healthcare utilization, and changes in CKM syndrome stage. Patient-reported health outcomes, patient activation, health literacy, and CKM syndrome stage will be assessed at baseline, 3 months, and 6 months, while healthcare utilization will be assessed prospectively over the 6-month follow-up period, with data collected at 3 and 6 months and updated through interim participant reports.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in the intervention arm will receive a 6-month AI chatbot-enabled, nurse-led ePRO monitoring and self-management program in addition to usual outpatient care. The AI chatbot will deliver weekly PROMIS-29 ePRO assessments and provide individualized feedback and self-management support based on prespecified decision rules. Clinically relevant symptom deterioration may trigger alerts for nurse review, with individualized support, care coordination, or clinical escalation provided when indicated. The AI chatbot will function as a decision-support and self-management tool and will not replace professional clinical judgment.
| Arm | Type | Receives |
|---|---|---|
| AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management | Experimental | Other: AI chatbot-enabled nurse-led program.Participants will receive usual outpatient care plus a 6-month AI chatbot-enabled ePRO monitoring and nurse-led self-management program, including weekly ePRO assessments, individualized feedback, self-management support, risk alerts, and nurse-led follow-up when indicated. |
| Control group | Other | Other: Usual CareParticipants will receive usual outpatient care and complete weekly ePRO assessments through a non-AI platform without automated feedback, individualized recommendations, risk alerts, or structured nurse-led support based on their weekly ePRO responses. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥40 years
- Meet the criteria for stage 1 or stage 2 cardiovascular-kidney-metabolic (CKM) syndrome
- Receive regular outpatient care at the study hospital
- Able to communicate in Chinese
- Able to provide written informed consent and complete the required study assessments
Key exclusion criteria (5 listed)
- Meet the criteria for stage 3 or stage 4 CKM syndrome, including known subclinical cardiovascular disease, a stage 3 cardiovascular risk equivalent, or established clinical cardiovascular disease
- Have kidney failure requiring chronic kidney replacement therapy
- Have a terminal illness with a life expectancy of <6 months
- Have cognitive impairment that, in the judgment of the treating physician or research team, precludes informed consent or meaningful participation in the intervention
- Are currently participating in another interventional study that could substantially influence the study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | AI Chatbot-Enabled ePRO Monitoring and Nurse-Led Self-Management |
| Usual CareUsual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination | Other | Control group |
Primary outcome
PROMIS-29 v2.1 Domain-Specific T-Scores and Pain Intensity
Time frame: Baseline, 3 months, and 6 months
The PROMIS-29 v2.1 Traditional Chinese version will be used to assess seven health domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Each domain contains four items and will be scored separately and converted to standardized T-scores with a reference-population mean of 50 and standard deviation of 10. Higher T-scores indicate greater symptom burden for Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Interference, whereas higher T-scores indicate better health for Physical Function and Ability to Participate in Social Roles and Activities. Pain Intensity will be assessed separately using a single 0-10 numeric rating scale, with higher scores indicating greater pain intensity.
4 secondary outcomes
Patient Activation Measure-13 (PAM-13)
Time frame: Baseline, 3 months, and 6 months.
Mandarin Multidimensional Health Literacy Questionnaire (MMHLQ)
Time frame: Baseline, 3 months, and 6 months.
Healthcare Utilization
Time frame: Enrollment to 3 months and 3 months to 6 months
Change in CKM Syndrome Stage
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI chatbot-enabled nurse-led program. in people with Cardiovascular-kidney-metabolic Syndrome, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Shan Tsai, PhD in Nursing (+886 2 2736 1661 ext. 27709, ptsai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS-29 v2.1 Domain-Specific T-Scores and Pain Intensity (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.