AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease
410 participantsStarted 2026-03-01
Plain-language 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)
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on predicting frailty risk in adults with congenital heart disease using AI tools like voice emotion detection, how might participating in this kind of observational study actually benefit my own care, or is the main goal to help future patients?
2This study is measuring depression and anxiety using patient-reported questionnaires — do you think my current mental health and symptom burden are things my care team is already tracking closely enough, or could a structured tool like this reveal something we might be missing?
3The trial isn't recruiting yet — given where I am in my treatment right now, does it make sense to wait and see if this study opens, or should we focus on other options in the meantime?
4Since this is a Phase NA study focused on building a prediction model rather than testing a treatment, what would actually be done with the results if I participated, and would I personally receive any feedback about my frailty risk?
5Are there existing frailty or mental health screening programs you already recommend for adults with congenital heart disease that might give me some of the same benefits this trial is aiming to provide?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression and Anxiety assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Scales
Timeframe: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention