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临床试验/NCT05544006
NCT05544006Enrolling By Invitation不适用

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 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
76
试验地点
1
主要终点
Heart failure-related hospitalizations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Hospitalisation due to heart failure decompensation
  • •Having a smartphone with internet access
  • •Willingness to participate in the study
  • •NYHA 2-4 symptoms

排除标准

  • •Diagnosis of active malignancy
  • •Pregnancy
  • •Vision and hearing problems
  • •Moderate to severe cognitive impairment

结局指标

主要结局

Heart failure-related hospitalizations

时间窗: 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

时间窗: 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

次要结局

  • Patient-reported outcomes(At baseline, Four weeks after discharge, Three months after discharge)

研究者

发起方
Albert Saglik Hizmetleri ve Ticaret A.S.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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