Impact of Socio Economic Limitations on Health Outcomes in Patients With Recent Admission for Heart Failure

NCT04022122 | Completed

• 1 other identifier: IDIBELL-2019/PR157/19
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the impact of the socio-economic level on the effectiveness of a comprehensive multidisciplinary program of transitional care for crhonic heart failure patients (primary objective); to analyze this specifically in the various chronic management profiles of CHF patients and to study the associations between socio-economic level and other psychosocial aspects (secondary objective).

Conditions

Heart Failure

Keywords

Socioeconomic Level; Disease Management; Chronic Care Model; Transitional Care

Outcome Measures

Primary Outcomes (1)

• Occurrence of cardiovascular death or non-fatal heart failure events

  Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (\<24 hours) or requiring unplanned hospital admission (\>24 hours) or complicating the course of a non-cardiovascular admission.

  Six months after inclusion of the patient.

Secondary Outcomes (8)

• Readmission (all-cause, HF and cardiovascular) rate and total number.

  Six months after inclusion of the patient.

• Days in hospital (all-cause, HF and cardiovascular).

  Six months after inclusion of the patient.

• Rate of emergency visits.

  Six months after inclusion of the patient.

• Rate of non-fatal HF events.

  Six months after inclusion of the patient.

• Mortality for any cause and cardiovascular mortality.

  Six months after inclusion of the patient.

Study Arms (1)

Heart Failure patients

The study does not imply any specific therapeutic intervention, and will not imply any change in the management of the participating patients, who will follow the usual clinical controls and will receive the medical and invasive treatments usually provided to patients with HF in our health area; as well as the different modalities of specific health education for this disease. At the time of hospital discharge, patients will be handled according to the usual protocols of the center established for outpatient follow-up of HF patients.

Procedure: Usual Care follow-up in a heart failure program.

Interventions

Usual Care follow-up in a heart failure program. PROCEDURE

Standard follow-up involves hospital and primary care for HF patients. In this context, physicians and nurses experienced in the care and management of HF direct care. HF care is based on 1) active detection of newly admitted HF patients, 2) planned educational interventions to improve self-care, 3) completion of a comprehensive psychosocial assessment of patients and caregivers, 4) discharge planning and home transition coordination involving the hospital HF team and Primary Care teams, 5) structured and planned evidence-based follow-up shortly after discharge from hospital.

Heart Failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It will include, consecutively, all patients with a HF hospitalization within 30 days, discharged alive, and whose main diagnosis at discharge is HF.

You may qualify if:

• Age ≥ 18 years old.
• Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning.
• Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria.
• Written informed consent must be obtained before any assessment is performed.
• Patients receiving oral standard medication for chronic heart failure (CHF).
• All patients will be eligible regardless the level of left ventricular ejection fraction (LVEF).

You may not qualify if:

• Age\<18 years old.
• Death before hospital discharge.
• The patient is unable or unwilling to give the informed consent to participate.
• Unstable patients with signs of fluid overload or low cardiac output.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (1)

University Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Josep Comín Colet, MD,PhD

  Head of the Cardiology Department and the Community Heart Failure Unit. MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Cardiology Department and the Community Heart Failure Unit

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 16, 2019
• Study Start: July 15, 2019
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

ES (1)