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Clinical Trials/NCT05544006
NCT05544006Enrolling By InvitationNot Applicable

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

Albert Saglik Hizmetleri ve Ticaret A.S.1 site in 1 country76 target enrollmentStarted: October 26, 2022Last updated:
Conditions

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)

Investigators

Sponsor
Albert Saglik Hizmetleri ve Ticaret A.S.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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