Heart FailureAIDMy-HFNCT05544006
Artificial Intelligence-Based Disease Management in the Vulnerable Period of Heart Failure
An observational study of Heart Failure, run by Albert Saglik Hizmetleri ve Ticaret A.S. at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2022to 2 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Hospitalisation due to heart failure decompensation
- Having a smartphone with internet access
- Willingness to participate in the study
- NYHA 2-4 symptoms
Who cannot join
- Diagnosis of active malignancy
- Pregnancy
- Vision and hearing problems
- Moderate to severe cognitive impairment
- Dementia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Research and Application Hospital
Izmir
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- heart failure, vocal biomarker
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure-related hospitalizations
The effect of acquired intermittent digital data including vocal biomarkers along with standardized discharge education on the HF-related hospitalization
Measured: 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
Measured: At baseline, Four weeks after discharge, Three months after discharge
Secondary outcomes (1)
Patient-reported outcomes
Multivariate logistic regression models of digital and vocal properties optimized for sensitivity to predict patient-reported outcomes, including dyspnea level (ranging from 1 to 4), edema(0 to +3) and HF-related hospitalization
Measured: At baseline, Four weeks after discharge, Three months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start26 Oct 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion2 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Saglik Hizmetleri ve Ticaret A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dokuz Eylul University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544006
- Sponsor's protocol ID
- 101052022
- Acronym
- AIDMy-HF
- Status last verified
- Nov 2022
- First submitted
- 11 Sep 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34447992Degertekin 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.
PubMed 22951845Yilmaz 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.
PubMed 30982817
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05544006
- Acronym / sponsor ID
- AIDMy-HF / 101052022
- Conditions
- Heart Failure
- Keywords
- heart failure, vocal biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Albert Saglik Hizmetleri ve Ticaret A.S.Industry (pharma, biotech, devices)
- Collaborators
- Dokuz Eylul University
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 2 Apr 2023 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Hospitalisation due to heart failure decompensation
- Having a smartphone with internet access
- Willingness to participate in the study
- NYHA 2-4 symptoms
Key exclusion criteria (5 listed)
- Diagnosis of active malignancy
- Pregnancy
- Vision and hearing problems
- Moderate to severe cognitive impairment
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Patient-reported outcomes
Time frame: At baseline, Four weeks after discharge, Three months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 22951845Degertekin 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.
- Background: PubMed 30982817Yilmaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Albert Saglik Hizmetleri ve Ticaret A.S. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure-related hospitalizations (time frame: At baseline, Four weeks after discharge, Three months after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05544006, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.