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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05544006
Acronym
AIDMy-HF
Enrollment
76
Registered
2022-09-16
Start date
2022-10-26
Completion date
2023-04-02
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, vocal biomarker

Brief summary

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

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.

Interventions

None listed

Sponsors

Dokuz Eylul University
CollaboratorOTHER
Albert Saglik Hizmetleri ve Ticaret A.S.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Heart failure-related hospitalizationsAt baseline, Four weeks after discharge, Three months after dischargeThe effect of acquired intermittent digital data including vocal biomarkers along with standardized discharge education on the HF-related hospitalization
Change from baseline in health-related quality of lifeAt baseline, Four weeks after discharge, Three months after dischargeThe 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

Secondary

MeasureTime frameDescription
Patient-reported outcomesAt baseline, Four weeks after discharge, Three months after dischargeMultivariate 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026