Predictive Models of Readmission in Heart Failure

NCT ID: NCT03300791

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-28

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective nested case-control study.

Our goals are to create predictive models to readmissions for heart failure and also to define profiles for patients who are readmitted during the first month after the index episode.

Patients who will be admitted in five hospitals in spain by the reason of a heart failure will be recruited during 18 months. Those who will be readmitted in a hospital up to a month after the index episode will be considered cases. Controls will be selected from the initial cohort of hospitalized patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: To create models for predicting the risk of readmission short term (30-90 days) and medium term (one year).To identify differences between patients readmitted and not readmitted, and profiles of frequently preventable readmissions in our setting.

Methodology: Observational prospective cohort of patients who are discharged with a diagnosis of heart failure in 5 participating centers. further, a nested case-control will be developed in the previous cohort, being cases those readmitted and controls will be chosen according to age, sex, etiology of heart failure, comorbidities and functional status. Sociodemographic, clinical and health related quality of life, empowerment and baseline self-efficacy as predictors of readmission were collected.

Regarding the cases and controls, the quality of life in post-discharge transitional period, empowerment and self-efficacy, caregiver burden, social support, discharge care model, use of health services and adequation, conciliation and adherence to treatment will be assessed . Cox proportional hazards models will be created, and conditional logistic regression models to identify differences between cases and controls.

Expected Results: National Health System will be provided with tools for predicting the risk of readmission useful to clinicians and managers to offer discharge individualized care. The most common characteristics of readmissions and preventable readmissions will be identified, which will be helpful to create specific actions in the future.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Admitted

We will include patients who had beeb admitted by an acute heart failure in hospitalization ward

Admitted

Intervention Type OTHER

Readmitted patients in the next months after an episode of aute heart failure will be recruited. Controls will be selected between those who were admitted in the baseline but not readmitted in this month.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Admitted

Readmitted patients in the next months after an episode of aute heart failure will be recruited. Controls will be selected between those who were admitted in the baseline but not readmitted in this month.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Not readmitted

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients admitted by acute heart failure (de novo and acute decompensated) (International Classification of Diseases, Ninth Revision, Clinical Modification: 428.x; some of the 402.x group), older tan 18 who will accept to participate.

Exclusion Criteria

* patients who develop HF episodes during admission, if have been admitted for another reason,
* patients transferred from other health centers,
* myocardial infarction or stroke in the 4 weeks prior to admission,
* life expectancy less than one year, for HF at the terminal or cause different from the CI according to the assessment of the study subjects,
* inability to complete the questionnaires or with assistance external (reviewer, family, social) because of sensorineural reason, dementia or ignorance of the language.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Basurto

OTHER

Sponsor Role collaborator

Hospital Donostia

OTHER

Sponsor Role collaborator

Hospital de Mendaro

UNKNOWN

Sponsor Role collaborator

Hospital Costa del Sol

OTHER

Sponsor Role collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role collaborator

Hospital Galdakao-Usansolo

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susana García Gutiérrez

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susana Garcia-Gutierrez, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marisa Bare

Sabadell, Barcelona, Spain

Site Status

Ainara

Bilbao, Bizkaia, Spain

Site Status

Irene Rilo

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Raul

Marbella, Málaga, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Garcia-Gutierrez S, Villanueva A, Lafuente I, Rodriguez I, Lozano-Bahamonde A, Murga N, Orus J, Camacho ER, Quintana JM, Quiros R; ReIC-REDISSEC working group. Factors related to early readmissions after acute heart failure: a nested case-control study. BMC Cardiovasc Disord. 2023 Jan 12;23(1):17. doi: 10.1186/s12872-022-03029-2.

Reference Type DERIVED
PMID: 36635633 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI15/01343-2015111003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.