AI Chatbot-Enabled ePRO Symptom Monitoring and Self-Management for Early Cardiovascular-Kidney-Metabolic Syndrome
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Pei Shan Tsai, PhD in Nursing
- 電話番号：6300 +886 2 2736 1661
- メール：ptsai@tmu.edu.tw
研究場所
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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、台湾
- Taipei Medical University
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PROMIS-29 v2.1
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PAM-13
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- N202603080
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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