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Completed

NCT Number: NCT04022122

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Occurrence of cardiovascular death or non-fatal heart failure events

    Time frame: Six months after inclusion of the patient.

    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.

Secondary outcomes

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

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

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

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

  3. Rate of emergency visits.

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

  4. Rate of non-fatal HF events.

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

  5. Mortality for any cause and cardiovascular mortality.

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

  6. Change of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale)

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

  7. Change of quality of life using a validated questionnaire (EUROQOL - 5D).

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

  8. Patient satisfaction using a Likert-type scale.

    Time frame: Six months after inclusion of the patient.

    Comparison of the different socioeconomic levels at the end of follow-up.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

  • Institut d'Investigació Biomèdica de Bellvitge

Registry information

Official study 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)

Acronym: SELENE

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 16, 2019
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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