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AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
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)
Trial Details
NCT Number NCT07479654
Lead Sponsor Mackay Memorial Hospital
Conditions
(from sponsor)		 Adult Congenital Heart Disease, Symptom Clusters, Frailty, Risk Prediction Model, Artificial Intelligence-Based Voice Emotion Detection
Related terms Frailty, Heart Defects, Congenital, Syndrome
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov