Artificial Intelligence-Based Disease Management in the Vulnerable Period of Heart Failure

Study Overview
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Brief Summary
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The study aims to evaluate the effect of AI-based discharge training after acute decompensation of heart failure on the patient's quality of life and to examine the relationship between changes in voice and speech characteristics of patients and changes in hospitalization, discharge, and early post-discharge clinical status.

Detailed Description
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Heart failure (HF) is a progressive disease with a fluctuating course. From time to time, patients' symptoms and signs worsen enough to require hospitalization, and hospitalization occurs with acute decompensated HF. Acute HF decompensations are periods that worsen the prognosis of the patient. On the other hand, patients discharged after an acute decompensation have the highest risk during the first months after discharge. Patients get trained about lifestyle changes and medication management during the discharge period. Recent guidelines suggest that patients in the early post-discharge period be called for virtual/telephone or face-to-face control visits at short intervals(3rd, 7th, 14th, and 28th days ), then at 3-6 monthly intervals according to NYHA class. In traditional cardiovascular practice, patients are called for outpatient control visit in the first month after discharge. However, the processes after the pandemic kept patients away from visiting the hospital at the frequency recommended in the American and European guidelines and caused them to stay at home not even following their routine visit schedules. Moreover, the risks and benefits of virtual visits in terms of patient prognosis are not well established. This study aims to investigate relationships between routinely recorded findings, symptoms, and vocal biomarkers of heart failure patients in the hospitalization and in the post-discharge period and to investigate the effect of post-discharge education on patient-reported outcomes and re-hospitalization.

Official Title
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Artificial Intelligence-Based Disease Management in the Vulnerable Period of Heart Failure, An Observational Study to Evaluate Patient Speech and Voice in the Vulnerable Phase of Heart Failure

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalisation due to heart failure decompensation Having a smartphone with internet access Willingness to participate in the study NYHA 2-4 symptoms Exclusion Criteria: Diagnosis of active malignancy Pregnancy Vision and hearing problems Moderate to severe cognitive impairment Dementia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active study group<br>Active study group with self monitoring reminders in 3,7,14,28th days after discharge | |
| Usual care group<br>Usual care group with self monitoring recommendations at discharge | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure-related hospitalizations | The effect of acquired intermittent digital data including vocal biomarkers along with standardized discharge education on the HF-related hospitalization | At baseline, Four weeks after discharge, Three months after discharge | 
| Change from baseline in health-related quality of life | The effect of acquired intermittent digital data including vocal biomarkers along with standardized discharge education on the patient's quality of life. SF-12(Short Form-12) will be used to evaluate the effect | At baseline, Four weeks after discharge, Three months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcomes | Multivariate logistic regression models of digital and vocal properties optimized for sensitivity to predict patient-reported outcomes, including dyspnea level (ranging from 1 to 4), edema(0 to +3) and HF-related hospitalization | At baseline, Four weeks after discharge, Three months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, vocal biomarker