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Predictive Models of Readmission in Heart Failure (REIC)

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ClinicalTrials.gov Identifier: NCT03300791
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Hospital de Basurto
Hospital Donostia
Hospital de Mendaro
Hospital Costa del Sol
Corporacion Parc Tauli
Information provided by (Responsible Party):
Susana García Gutiérrez, Hospital Galdakao-Usansolo

Brief Summary:

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.


Condition or disease Intervention/treatment
Heart Failure Other: Admitted

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Predictive Models of Readmission in Heart Failure: Profile of Readmitted Patients
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Admitted
We will include patients who had beeb admitted by an acute heart failure in hospitalization ward
Other: 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.
Other Name: Not readmitted




Primary Outcome Measures :
  1. Readmission [ Time Frame: 1 month ]
    Up to a month after admission by heart failure


Secondary Outcome Measures :
  1. Readmission [ Time Frame: 12 months ]
    Up to 12 months after admission by heart failure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted by the reason of heart failure
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300791


Contacts
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Contact: Susana Garcia-Gutierrez, PhD +34 944007105 ext 3044 susana.garciagutierrez@osakidetza.eus
Contact: Iratxe Lafuente, MSc +34944007105 ext 2163 iratxe.lafuenteguerrero@osakidetza.eus

Locations
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Spain
Marisa Bare Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Marisa Bare, PhD    93 7458245    mbare@pauli.cat   
Ainara Recruiting
Bilbao, Bizkaia, Spain, 48013
Contact: Ainara Lozano, MD       ainara.lozanobahamonde@osakidetza.eus   
Irene Rilo Recruiting
Donostia San Sebastian, Gipuzkoa, Spain, 20014
Contact: Irene Rilo, MD    9437000 ext 3704    irene.rilomiranda@sakidetza.eus   
Raul Recruiting
Marbella, Málaga, Spain, 29600
Contact: Raul Quiros, MD       quiroslopez77@gmail.com   
Contact: Emi Rosa       hemiroca@hotmail.com   
Principal Investigator: Raul Quiros, MD         
Sponsors and Collaborators
Hospital Galdakao-Usansolo
Hospital de Basurto
Hospital Donostia
Hospital de Mendaro
Hospital Costa del Sol
Corporacion Parc Tauli
Investigators
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Principal Investigator: Susana Garcia-Gutierrez, PhD Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza

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Responsible Party: Susana García Gutiérrez, PhD, Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier: NCT03300791     History of Changes
Other Study ID Numbers: PI15/01343-2015111003
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susana García Gutiérrez, Hospital Galdakao-Usansolo:
heart failure
readmission
predictive models
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases