- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905226
Development of a Predictive Algorithm for the Risk of Rehospitalization of Patients With Heart Failure
Heart failure is a chronic disease whose prevalence, due to the aging of the population, is increasing. In France, the prevalence of this pathology is 2.3% (it reaches 10% in the over 75 years) and affects nearly a million patients.
The rehospitalization of patients with heart failure affects 25% of patients within 1-3 months of hospital discharge, and 66% at 1 year while 75% of hospitalizations are preventable. These readmissions result in decreased quality of life and increased mortality; from an economic point of view, hospitalization accounts for 70% of expenses related to the management of heart failure. Avoiding rehospitalization is therefore a major public health issue. The current predictive scores remain perfectible, even though risk factors for readmission have already been the subject of numerous studies. The identification of patients at risk of rehospitalization is still an issue, especially for patients with preserved left ventricular ejection fraction. Targeting patients requiring appropriate care remains an issue.
The rise of innovative statistical techniques around Big Data in health opens new perspectives for the scientific exploitation of data available in electronic medical records, for example in the field of prediction. This study aims to explore the risk of rehospitalization in heart failure patients by analyzing routine data collected in medical records and by mobilizing artificial intelligence algorithms. A review of the literature confirms the innovative nature of such an approach: the majority of the studies identified implemented a prospective collection of data; only 20% of the studies mobilized the medical file; no French study used the new machine learning algorithms.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients older than 18 years
- Patients with heart failure hospitalized in the cardiology department ath GHPSJ between january 2015 to december 2018
Exclusion Criteria:
- Patient opposing the use of his data for this research
- Patient under tutorship or curatorship
- Patient deprived of liberty
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Heart Failure
Patients whom initiated a hospital pathway for heart failure management within the Paris Saint Joseph Hospital Group (GHPSJ) between January 1, 2015 and December 31, 2018.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of readmissions
Time Frame: month 1
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Comparison of the number of readmissions predicted to the number actually observed with calculation of the sensitivity and specificity of the model at the validation phase.
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month 1
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Number of readmissions
Time Frame: Month 6
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Comparison of the number of readmissions predicted to the number actually observed with calculation of the sensitivity and specificity of the model at the validation phase.
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Month 6
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Number of readmissions
Time Frame: Year 1
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Comparison of the number of readmissions predicted to the number actually observed with calculation of the sensitivity and specificity of the model at the validation phase.
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Year 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Philippe ABASSADE, MD, Groupe Hospitalier Paris Saint Joseph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREDIC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
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Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
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US Department of Veterans AffairsCompleted