Trials / Not Yet Recruiting
Not Yet RecruitingNCT07479654
AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease
Precision Risk Prediction of Symptom Clusters and Frailty With AI-Guided Emotion Detection: A Three-Year Study in Adults With Congenital Heart Disease
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- Sponsor
- Mackay Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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)
Conditions
- Adult Congenital Heart Disease
- Symptom Clusters
- Frailty
- Risk Prediction Model
- Artificial Intelligence-Based Voice Emotion Detection
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | AI-Based Voice Emotion Detection-Guided Counselling | Participants assigned to the intervention arm will receive an artificial intelligence-based voice emotion detection-guided counselling intervention in addition to usual care. The intervention uses voice recordings collected during structured counselling sessions to analyze emotional features, including emotional valence and arousal, through artificial intelligence-based voice emotion detection algorithms. Based on the analyzed emotional profiles, individualized psychological feedback and counselling guidance are provided to support emotional regulation, stress coping, and adaptive self-management. The counselling content is tailored to participants' emotional states and symptom experiences and focuses on reducing psychological distress, improving sleep and fatigue management, enhancing grit, and promoting quality of life. The intervention is delivered by trained healthcare professionals following a standardized protocol, with sessions conducted at predefined intervals during the inter |
| BEHAVIORAL | Usual Care (Control) | Usual Care |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2026-03-18
- Last updated
- 2026-03-18
Source: ClinicalTrials.gov record NCT07479654. Inclusion in this directory is not an endorsement.