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

Catalan Institute of Health

Status: Completed

Conditions: Heart Failure

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

Study type: Observational

Funder types: Other

Identifiers

NCT04022122

IDIBELL-2019/PR157/19

Details and patient eligibility

About

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).

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

121 participants in 1 patient group

Heart Failure patients

Description:

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.

Treatment:

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