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AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome

5. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Pei Shan Tsai, PhD in Nursing
  • Telefonnummer: 6300 +886 2 2736 1661
  • E-mail: ptsai@tmu.edu.tw

Studiesteder

  • Taiwan
    • No. 250號, Wuxing St, Xinyi District, Taipei City, 110
      • Taipei, No. 250號, Wuxing St, Xinyi District, Taipei City, 110, Taiwan
        • Taipei Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AI chatbot-enabled nurse-led program
Andet: 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.
Andet: Control group
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
Andet: Usual Care
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PROMIS-29 v2.1
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PAM-13
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taipei Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. maj 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

31. juli 2029

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • N202603080

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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