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Not yet recruiting NCT07479654

AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease

No phase Interventional Adult Congenital Heart Disease Symptom Clusters Frailty Risk Prediction Model

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Based Voice Emotion Detection-Guided Counselling, Usual Care (Control).
Who it may be relevant to
Registry conditions: Adult Congenital Heart Disease, Symptom Clusters, Frailty, Risk Prediction Model. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Precision Risk Prediction of Symptom Clusters and Frailty With AI-Guided Emotion Detection: A Three-Year Study in Adults With Congenital Heart Disease

Overview

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)

Interventions

  • 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 counsel
  • Behavioral Usual Care (Control)
    Usual Care

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Chinese version of the Satisfaction with Life Scale; SWLS [Time frame: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention]
  • Grit-10 [Time frame: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention]
  • The Chinese Version of Fatigue Assessment Scale; FAS-C [Time frame: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07479654 · 25MMHIS443e

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗