The Value of a Simple Tool for the Early Detection of Decompensated Heart Failure in People Over 55 on Réunion Island: A Preliminary Study in Hospitals (DEPIST'IC-RUN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Estimating the discriminant validity of a tool for detecting decompensated heart failure
研究概览
简要总结
The goal of this study is to assess the discriminatory power of a previously developed tool for detecting decompensated heart failure-which includes, in particular, clinical signs-in a population of patients hospitalized in cardiology units in Réunion. The main question it aims to answer is : Would a simple and rapid screening tool for decompensated heart failure help identify a high probability of this condition in a population hospitalized in a cardiology unit in Réunion? This study includes patients aged 55 and older, who reside in Réunion, who were admitted on an unscheduled basis to the cardiology department at the Réunion University Hospital or the Ouest Réunion Hospital, for any reason (whether as an inpatient or in the intensive care unit)
The study is conducted in two phases:
Phase 1: Development of the new e-DELPHI consensus-based screening tool Phase 2: Administration of the Déspist'IC-Run early detection tool for decompensated heart failure and performance of the gold standard cardiology examination (RIPH3)
详细描述
This is a preliminary, cross-sectional "diagnostic" ("screening") study (to assess validity relative to the gold standard test), conducted at two centers, evaluating a questionnaire that does not alter the patient's standard of care (prospective data collection).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 55 and older
- •Admitted on an unscheduled basis to the cardiology department at the CHU (North and South campuses) and the CHOR for any reason (in general wards or intensive care)
- •Residents of Réunion
- •Able to read and write French
- •Enrolled in a social security program
- •Willing to participate in the study
排除标准
- •Who cannot communicate in French
- •For whom it is impossible to administer the questionnaire
- •For whom the ETT and/or cardiology consultation are impossible
- •Who are under guardianship, conservatorship, or judicial protection
研究组 & 干预措施
Cardiology patients
Patients aged 55 or older admitted to a cardiology unit for any reason
干预措施: Early Detection Questionnaire (Diagnostic Test)
结局指标
主要结局
Estimating the discriminant validity of a tool for detecting decompensated heart failure
时间窗: "From enrollment to the end of the study, at 6 month
The probability of having decompensated heart failure, as determined by a screening tool in the form of a questionnaire, will be calculated using the equation of a logistic regression model that explains the observed status (dependent variable) as determined by the gold standard test. The gold standard test for establishing a definitive diagnosis of decompensated heart failure will combine three tests: a clinical examination by a cardiologist, a transthoracic Doppler echocardiogram (TTE), and an electrocardiogram.
次要结局
- Describe the operational phases involved in developing the screening tool.(From enrolment to the end of the study, at 6 month)
- Describe the sociodemographic and clinical characteristics, as well as the lifestyle habits, of the study population.(From enrollment to the end of the study at 6 months)
- Compare the sociodemographic and medical characteristics of this population of patients hospitalized in cardiology with those of other populations of patients with heart failure seen in private practices-whether in cardiology or general practice(From enrollment to the end of the study at 6 month)