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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Occurrence of cardiovascular death or non-fatal heart failure events
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Occurrence of cardiovascular death or non-fatal heart failure events
时间窗: 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.
次要结局
- Patient satisfaction using a Likert-type scale.(Six months after inclusion of the patient.)
- Rate of emergency visits.(Six months after inclusion of the patient.)
- Mortality for any cause and cardiovascular mortality.(Six months after inclusion of the patient.)
- Readmission (all-cause, HF and cardiovascular) rate and total number.(Six months after inclusion of the patient.)
- Change of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale)(Six months after inclusion of the patient.)
- Rate of non-fatal HF events.(Six months after inclusion of the patient.)
- Days in hospital (all-cause, HF and cardiovascular).(Six months after inclusion of the patient.)
- Change of quality of life using a validated questionnaire (EUROQOL - 5D).(Six months after inclusion of the patient.)
研究者
Josep Comín
Head of the Cardiology Department and the Community Heart Failure Unit
Hospital Universitari de Bellvitge