NCT05544006

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2023

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

September 11, 2022

Last Update Submit

November 30, 2022

Conditions

Heart Failure

Keywords

heart failurevocal biomarker

Outcome Measures

Primary Outcomes (2)

  • Heart failure-related hospitalizations

    The effect of acquired intermittent digital data including vocal biomarkers along with standardized discharge education on the HF-related hospitalization

    At baseline, Four weeks after discharge, Three months after discharge

  • Change from baseline in health-related quality of life

    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

    At baseline, Four weeks after discharge, Three months after discharge

Secondary Outcomes (1)

  • Patient-reported outcomes

    At baseline, Four weeks after discharge, Three months after discharge

Study Arms (2)

Active study group

Active study group with self monitoring reminders in 3,7,14,28th days after discharge

Usual care group

Usual care group with self monitoring recommendations at discharge

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Research and Application Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 34447992BACKGROUND

  • 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.

    PMID: 22951845BACKGROUND

  • 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.

    PMID: 30982817BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 16, 2022

Study Start

October 26, 2022

Primary Completion

March 30, 2023

Study Completion

April 2, 2023

Last Updated

December 1, 2022

Record last verified: 2022-11

Locations

TU(1)