AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease

Sponsor
Mackay Memorial Hospital
Study ID
NCT07479654
Status
Not Yet Recruiting

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Conditions

  • Adult Congenital Heart Disease
  • Artificial Intelligence-Based Voice Emotion Detection
  • Frailty
  • Risk Prediction Model
  • Symptom Clusters

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AI-Based Voice Emotion Detection-Guided Counselling — BEHAVIORAL
    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
  • Usual Care (Control) — BEHAVIORAL
    Usual Care

Study Details

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)

Key Dates

First listed
Mar 18, 2026
Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Depression and Anxiety assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Scales [ Time Frame: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention ]

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