Clinical trial NCT05544006: Artificial Intelligence-Based Disease Management in the Vulnerable Period of Heart Failure
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: heart failure
vocal biomarker
Lead sponsor: Albert Saglik Hizmetleri ve Ticaret A.S.
Sponsor class: INDUSTRY
Collaborators: name: Dokuz Eylul University
First posted: 2022-09-16
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized adult patients admitted to the Cardiology Department due to heart failure decompensation and signed a written consent will be included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart failure-related hospitalizations
timeFrame: At baseline, Four weeks after discharge, Three months after discharge
measure: Change from baseline in health-related quality of life
timeFrame: At baseline, Four weeks after discharge, Three months after discharge
Secondary outcomes:
measure: Patient-reported outcomes
timeFrame: At baseline, Four weeks after discharge, Three months after discharge
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University Research and Application Hospital
Study officials:
References:
citation: McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
citation: Degertekin M, Erol C, Ergene O, Tokgozoglu L, Aksoy M, Erol MK, Eren M, Sahin M, Eroglu E, Mutlu B, Kozan O. [Heart failure prevalence and predictors in Turkey: HAPPY study]. Turk Kardiyol Dern Ars. 2012 Jun;40(4):298-308. doi: 10.5543/tkda.2012.65031. Turkish.
citation: Yilmaz MB, Celik A, Cavusoglu Y, Bekar L, Onrat E, Eren M, Kutlu M, Yalta K, Temizhan A, Kilicaslan B, Gungor H, Acikel M, Demir M, Akdemir R, Zoghi M, Tokgozoglu L. [Snapshot evaluation of heart failure in Turkey: Baseline characteristics of SELFIE-TR]. Turk Kardiyol Dern Ars. 2019 Apr;47(3):198-206. doi: 10.5543/tkda.2019.66877. Turkish.