<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03300791</url>
  </required_header>
  <id_info>
    <org_study_id>PI15/01343-2015111003</org_study_id>
    <nct_id>NCT03300791</nct_id>
  </id_info>
  <brief_title>Predictive Models of Readmission in Heart Failure</brief_title>
  <acronym>REIC</acronym>
  <official_title>Predictive Models of Readmission in Heart Failure: Profile of Readmitted Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Galdakao-Usansolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Basurto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Donostia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Mendaro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Costa del Sol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Galdakao-Usansolo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective nested case-control study.&#xD;
&#xD;
      Our goals are to create predictive models to readmissions for heart failure and also to&#xD;
      define profiles for patients who are readmitted during the first month after the index&#xD;
      episode.&#xD;
&#xD;
      Patients who will be admitted in five hospitals in spain by the reason of a heart failure&#xD;
      will be recruited during 18 months. Those who will be readmitted in a hospital up to a month&#xD;
      after the index episode will be considered cases. Controls will be selected from the initial&#xD;
      cohort of hospitalized patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To create models for predicting the risk of readmission short term (30-90 days)&#xD;
      and medium term (one year).To identify differences between patients readmitted and not&#xD;
      readmitted, and profiles of frequently preventable readmissions in our setting.&#xD;
&#xD;
      Methodology: Observational prospective cohort of patients who are discharged with a diagnosis&#xD;
      of heart failure in 5 participating centers. further, a nested case-control will be developed&#xD;
      in the previous cohort, being cases those readmitted and controls will be chosen according to&#xD;
      age, sex, etiology of heart failure, comorbidities and functional status. Sociodemographic,&#xD;
      clinical and health related quality of life, empowerment and baseline self-efficacy as&#xD;
      predictors of readmission were collected.&#xD;
&#xD;
      Regarding the cases and controls, the quality of life in post-discharge transitional period,&#xD;
      empowerment and self-efficacy, caregiver burden, social support, discharge care model, use of&#xD;
      health services and adequation, conciliation and adherence to treatment will be assessed .&#xD;
      Cox proportional hazards models will be created, and conditional logistic regression models&#xD;
      to identify differences between cases and controls.&#xD;
&#xD;
      Expected Results: National Health System will be provided with tools for predicting the risk&#xD;
      of readmission useful to clinicians and managers to offer discharge individualized care. The&#xD;
      most common characteristics of readmissions and preventable readmissions will be identified,&#xD;
      which will be helpful to create specific actions in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission</measure>
    <time_frame>1 month</time_frame>
    <description>Up to a month after admission by heart failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>12 months</time_frame>
    <description>Up to 12 months after admission by heart failure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1250</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Admitted</arm_group_label>
    <description>We will include patients who had beeb admitted by an acute heart failure in hospitalization ward</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Admitted</intervention_name>
    <description>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.</description>
    <arm_group_label>Admitted</arm_group_label>
    <other_name>Not readmitted</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted by the reason of heart failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted by acute heart failure (de novo and acute decompensated)&#xD;
             (International Classification of Diseases, Ninth Revision, Clinical Modification:&#xD;
             428.x; some of the 402.x group), older tan 18 who will accept to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who develop HF episodes during admission, if have been admitted for another&#xD;
             reason,&#xD;
&#xD;
          -  patients transferred from other health centers,&#xD;
&#xD;
          -  myocardial infarction or stroke in the 4 weeks prior to admission,&#xD;
&#xD;
          -  life expectancy less than one year, for HF at the terminal or cause different from the&#xD;
             CI according to the assessment of the study subjects,&#xD;
&#xD;
          -  inability to complete the questionnaires or with assistance external (reviewer,&#xD;
             family, social) because of sensorineural reason, dementia or ignorance of the&#xD;
             language.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susana Garcia-Gutierrez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marisa Bare</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ainara</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irene Rilo</name>
      <address>
        <city>Donostia San Sebastian</city>
        <state>Gipuzkoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raul</name>
      <address>
        <city>Marbella</city>
        <state>Málaga</state>
        <zip>29600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Galdakao-Usansolo</investigator_affiliation>
    <investigator_full_name>Susana García Gutiérrez</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>readmission</keyword>
  <keyword>predictive models</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03300791
org study id: PI15/01343-2015111003
nct id: NCT03300791
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Readmission
time frame: 1 month
description: Up to a month after admission by heart failure
measure: Readmission
time frame: 12 months
description: Up to 12 months after admission by heart failure
arm group label: Admitted
description: We will include patients who had beeb admitted by an acute heart failure in hospitalization ward
intervention type: Other
intervention name: Admitted
description: 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.
arm group label: Admitted
other name: Not readmitted
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susana Garcia-Gutierrez, PhD
role: Principal Investigator
affiliation: Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Galdakao-Usansolo
investigator full name: Susana García Gutiérrez
investigator title: PhD
mesh term: Heart Failure
sharing ipd: Undecided