AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Pei Shan Tsai, PhD in Nursing
- Telefonní číslo: 6300 +886 2 2736 1661
- E-mail: ptsai@tmu.edu.tw
Studijní místa
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No. 250號, Wuxing St, Xinyi District, Taipei City, 110
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Taipei, No. 250號, Wuxing St, Xinyi District, Taipei City, 110, Tchaj-wan
- Taipei Medical University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: AI chatbot-enabled nurse-led program
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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.
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Jiný: Control group
Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
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Usual care based on standard outpatient follow-up, without access to the AI chatbot or nurse-led coordination
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PROMIS-29 v2.1
Časové okno: Baseline, 3 months, and 6 months after randomization
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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
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Baseline, 3 months, and 6 months after randomization
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PAM-13
Časové okno: Baseline, 3 months, and 6 months.
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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
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Baseline, 3 months, and 6 months.
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MMHLQ
Časové okno: Baseline, 3 months, and 6 months.
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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).
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Baseline, 3 months, and 6 months.
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Number of emergency department visit
Časové okno: Baseline, 3 months, and 6 months.
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the total count of times a patient visits the emergency department within a specified period during intervention program
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Baseline, 3 months, and 6 months.
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Hospitalizations
Časové okno: Baseline, 3 months, and 6 months
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The number of times a patient is admitted to a hospital within a specified period during intervention program
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Baseline, 3 months, and 6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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