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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Heart failure-related hospitalizations
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Heart failure-related hospitalizations
Time Frame: At baseline, Four weeks after discharge, Three months after discharge
The 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 life
Time Frame: At baseline, Four weeks after discharge, Three months after discharge
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
Secondary Outcomes
- Patient-reported outcomes(At baseline, Four weeks after discharge, Three months after discharge)
