Clinical trial NCT04022122: Impact of Socio Economic Limitations on Health Outcomes in Patients With Recent Admission for Heart Failure
Official title: Impact of Socio Economic Limitations on hEalth Outcomes in Patients With Complex and Advanced Chronic Cardiovascular Conditions in High-standard iNtegrated Care Environements (SELENE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Socioeconomic Level
Disease Management
Chronic Care Model
Transitional Care
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Bellvitge
First posted: 2019-07-16
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Detailed description: The SELENE Study (Impact of SocioEconomic Limitations on health outcomes in patients with complex and advanced chronic cardiovascular conditions in high-standard iNtegrated care Environments) is an observational, cohort, prospective, multicenter study of consecutive patients treated in a comprehensive heart failure (HF) management program, and hospitalized by decompensated HF in our healthcare area; aimed at evaluating the impact of socioeconomic level on the effectiveness of a comprehensive multidisciplinary program of transitional care to patients with HF, both globally and in the various profiles of chronic management of HF.

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

All patients will have a detailed assessment by a social worker of a battery of psychosocial and functional variables, including educational level, functional status, cognitive status, family support, or the existence of a primary caregiver and an assessment of purchasing power through the value of monthly income. The events that will be analyzed, both for the primary objective of the study and the secondary objective related to the different follow-up profiles, will be re-admissions at 30 days (primary event), and mortality at 30, 90 and 180 days, as well as hospital admission at 90 days and 6 months (secondary events). Using the "median" income group as a reference, comparisons will be made between the rates of these events among the different groups.

The researchers hypothesize that the socioeconomic level has an impact on clinical events of HF patients so that the effectiveness of comprehensive care programs for HF is attenuated in patients with low socioeconomic level.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Occurrence of cardiovascular death or non-fatal heart failure events
timeFrame: Six months after inclusion of the patient.
Secondary outcomes:
measure: Readmission (all-cause, HF and cardiovascular) rate and total number.
timeFrame: Six months after inclusion of the patient.
measure: Days in hospital (all-cause, HF and cardiovascular).
timeFrame: Six months after inclusion of the patient.
measure: Rate of emergency visits.
timeFrame: Six months after inclusion of the patient.
measure: Rate of non-fatal HF events.
timeFrame: Six months after inclusion of the patient.
measure: Mortality for any cause and cardiovascular mortality.
timeFrame: Six months after inclusion of the patient.
measure: Change of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale)
timeFrame: Six months after inclusion of the patient.
measure: Change of quality of life using a validated questionnaire (EUROQOL - 5D).
timeFrame: Six months after inclusion of the patient.
measure: Patient satisfaction using a Likert-type scale.
timeFrame: Six months after inclusion of the patient.
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: University Hospital Bellvitge
state: Barcelona
Study officials:
affiliation: Head of the Cardiology Department and the Community Heart Failure Unit. MD, PhD
name: Josep Comín Colet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: