Adult Congenital Heart DiseaseNCT07479654
AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease
A study testing AI-Based Voice Emotion Detection-Guided Counselling in people with Adult Congenital Heart Disease and Symptom Clusters, run by Mackay Memorial Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adult Congenital Heart Disease, Symptom Clusters, Frailty
- What is being tested?
- AI-Based Voice Emotion Detection-Guided Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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:
Read more
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
- Being tested
- AI-Based Voice Emotion Detection-Guided Counselling, Usual Care (Control)
- Medical subject headings
- Heart Defects, Congenital, Syndrome, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Voice Emotion Detection-Guided CounsellingBehavioural
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)Behavioural
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| AI-Based Voice Emotion Detection-Guided Counselling (Intervention) | Experimental | 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. Receives: Behavioral: AI-Based Voice Emotion Detection-Guided Counselling |
| Usual Care (Control) | Active comparator | 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. Receives: Behavioral: Usual Care (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression and Anxiety assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Scales
The PROMIS Depression Short Form evaluates negative mood, feelings of hopelessness, helplessness, and loss of interest.
The PROMIS Anxiety Short Form assesses emotional distress related to feelings of fear, worry, tension, and hyperarousal.
Each scale consists of multiple items rated on a 5-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Almost Always) based on the participant's experiences during the past 7 days.
Raw scores are summed and converted to PROMIS T-scores, standardized to a population mean of 50 with a standard deviation of 10.
Possible raw score range: 8-40 (for the 8-item short form).
Higher scores indicate greater levels of depressive or anxiety symptoms (worse outcomes).
Measured: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention
Secondary outcomes (3)
Chinese version of the Satisfaction with Life Scale; SWLS
This study used the Chinese version of the Satisfaction With Life Scale (SWLS) (Wu \& Yao, 2006), which consists of five items rated on a seven-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher total scores indicate greater overall life satisfaction. The scale has been applied in adult patients with congenital heart disease (Liu, Lu, et al., 2024) and demonstrated excellent internal consistency, with a Cronbach's α of 0.93, indicating good reliability of the Chinese version.
Measured: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention
Grit-10
Duckworth et al. (2007) proposed the Grit Scale to conceptualize grit as comprising two dimensions: Perseverance of Effort (six items) and Consistency of Interests (six items), yielding a total of 12 items. The overall internal consistency of the original scale was 0.85, with Cronbach's α values of 0.78 for the Perseverance of Effort subscale and 0.84 for the Consistency of Interests subscale, indicating good reliability (Duckworth \& Quinn, 2009).
The Chinese version of the Grit Scale (Grit-10) was adapted from the original 12-item English version and revised to include 10 items loading on two factors. The Passion factor (reverse-coded) includes items such as "I often set a goal but then quickly change it," whereas the Perseverance factor includes items such as "I finish whatever I begin." Responses are rated on a five-point Likert scale ranging from 1 (not at all like me) to 5 (very much like me). Each item is scored from 1 to 5; odd-numbered items are reverse-coded and even-numbere
Measured: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention
The Chinese Version of Fatigue Assessment Scale; FAS-C
The Fatigue Assessment Scale-Chinese version (FAS-C) is a self-reported instrument designed to measure subjective fatigue and is particularly suitable for use in populations with chronic illnesses, cardiovascular diseases, and the general adult population (Michielsen et al., 2003). The original FAS consists of 10 items encompassing two domains: physical fatigue and mental fatigue. The Chinese version was developed through a rigorous process of translation, back-translation, and cultural adaptation, and has demonstrated satisfactory psychometric properties, including excellent internal consistency (Cronbach's α = 0.92) and good test-retest reliability (Lee, 2024).
Each item is rated on a five-point Likert scale ranging from 1 (never) to 5 (always), yielding a total score between 10 and 50, with higher scores indicating greater fatigue severity. The FAS-C is brief and easy to administer, with high sensitivity in distinguishing different levels of fatigue, making it suitable for clinica
Measured: Baseline, 2 weeks, 1 month, and 3 months after initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Shiu Liu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479654
- Sponsor's protocol ID
- 25MMHIS443e
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07479654
- Acronym / sponsor ID
- 25MMHIS443e
- Conditions
- Adult Congenital Heart Disease, Symptom Clusters, Frailty, Risk Prediction Model, Artificial Intelligence-Based Voice Emotion Detection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Based Voice Emotion Detection-Guided Counselling (Intervention) | Experimental | Behavioral: AI-Based Voice Emotion Detection-Guided CounsellingParticipants 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. |
| Usual Care (Control) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Based Voice Emotion Detection-Guided CounsellingParticipants 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 | Behavioural | AI-Based Voice Emotion Detection-Guided Counselling (Intervention) |
| Usual Care (Control)Usual Care | Behavioural | Usual Care (Control) |
Primary outcome
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
The PROMIS Depression Short Form evaluates negative mood, feelings of hopelessness, helplessness, and loss of interest. The PROMIS Anxiety Short Form assesses emotional distress related to feelings of fear, worry, tension, and hyperarousal. Each scale consists of multiple items rated on a 5-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Almost Always) based on the participant's experiences during the past 7 days. Raw scores are summed and converted to PROMIS T-scores, standardized to a population mean of 50 with a standard deviation of 10. Possible raw score range: 8-40 (for the 8-item short form). Higher scores indicate greater levels of depressive or anxiety symptoms (worse outcomes).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Based Voice Emotion Detection-Guided Counselling in people with Adult Congenital Heart Disease and Symptom Clusters, run by Mackay Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.