Precision Risk Prediction of Symptom Clusters and Frailty With AI-Guided Emotion Detection: A Three-Year Study in Adults With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 410
- 主要终点
- Depression and Anxiety assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Scales
研究概览
简要总结
The goal of this three-year mixed-methods observational study with an embedded randomized controlled trial is to develop and validate a frailty risk prediction model and evaluate an artificial intelligence-based voice emotion detection-guided counselling intervention in adults with congenital heart disease (ACHD).
The main questions it aims to answer are:
Are symptom clusters associated with frailty and psychological outcomes in adults with congenital heart disease?
Can symptom clusters and psychosocial factors be used to predict frailty risk over time in ACHD patients?
Does an AI-based voice emotion detection-guided counselling intervention improve psychological outcomes, fatigue, and quality of life among high-risk ACHD patients?
Researchers will compare ACHD patients receiving AI-based voice emotion detection-guided counselling with those receiving usual care to determine whether the intervention reduces depression, anxiety, sleep disturbance, fatigue, and frailty risk, and improves grit and quality of life.
Participants will:
Complete longitudinal assessments of symptom clusters, frailty, and psychological status at baseline and follow-up time points
Participate in qualitative interviews to explore lived experiences related to symptoms and frailty
Receive AI-based voice emotion detection-guided counselling (intervention group only in Year 3)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 years or older.
- •Diagnosed with congenital heart disease by a physician.
- •Able to communicate in Mandarin or Taiwanese, with normal cognitive function.
排除标准
- •Presence of other congenital anomalies.
- •Currently hospitalized for acute decompensation, or having severe cognitive impairment or psychiatric symptoms that preclude completion of questionnaires.
- •Pregnant individuals.
研究组 & 干预措施
AI-Based Voice Emotion Detection-Guided Counselling (Intervention)
Participants assigned to this arm will receive an artificial intelligence-based voice emotion detection-guided counselling intervention in addition to usual care. The intervention uses voice emotion analysis to provide personalized psychological feedback and counselling aimed at improving emotional regulation, reducing psychological distress, and enhancing quality of life.
干预措施: AI-Based Voice Emotion Detection-Guided Counselling (Behavioral)
Usual Care (Control)
Participants assigned to this arm will receive usual clinical care for adult congenital heart disease without the AI-based voice emotion detection-guided counselling intervention.
干预措施: Usual Care (Control) (Behavioral)
结局指标
主要结局
Depression and Anxiety assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Scales
时间窗: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention
The PROMIS Depression Short Form evaluates negative mood, feelings of hopelessness, helplessness, and loss of interest. The PROMIS Anxiety Short Form assesses emotional distress related to feelings of fear, worry, tension, and hyperarousal. Each scale consists of multiple items rated on a 5-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Almost Always) based on the participant's experiences during the past 7 days. Raw scores are summed and converted to PROMIS T-scores, standardized to a population mean of 50 with a standard deviation of 10. Possible raw score range: 8-40 (for the 8-item short form). Higher scores indicate greater levels of depressive or anxiety symptoms (worse outcomes).
次要结局
- Chinese version of the Satisfaction with Life Scale; SWLS(Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention)
- Grit-10(Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention)
- The Chinese Version of Fatigue Assessment Scale; FAS-C(Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention)
研究者
Yu-Shiu Liu
Assistant Professor
Mackay Memorial Hospital