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临床试验/NCT07660757
NCT07660757已完成不适用

Epidemiological Cluster Evaluation in Patients Admitted to Internal Medicine, With at Least One of the Following Diagnoses: Heart Failure, COPD, Renal Failure. The FADOI IN-CluDiMI Study

Fadoi Foundation, Italy1 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2023年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,500
试验地点
1
主要终点
Identifying disease clusters (defined as the co-presence of at least two additional diseases) in patients suffering from at least one of the following chronic diseases: heart failure, COPD, and chronic kidney disease

研究概览

简要总结

Improved medical care has led to an increase in both the age and clinical complexity of patients admitted to Internal Medicine wards, characterized by multiple chronic diseases. Multimorbidity is a common issue in the elderly, significantly associated with higher mortality, functional decline, and poorer quality of life. The concept of "disease clustering" goes beyond simple multimorbidity or comorbidity by grouping statistically associated morbid conditions to understand their interconnections, shared risk factors, and pathophysiological mechanisms. The goal is to identify these clusters in relation to the most common chronic conditions in Internal Medicine: heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease.This is an observational, multicenter, prospective, national study sponsored by the FADOI Foundation (Federation of Associations of Internal Medicine Hospital) and this is a non-profit research project. It aims to involve about 50 Internal Medicine Units, targeting the enrollment of approximately 100 consecutive adult patients per unit, for a total of at least 1500 subjects per pathology group.

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

入选标准

  • Patients admitted to Internal Medicine with a diagnosis of at least one of the following chronic conditions:
  • heart failure
  • chronic kidney disease
  • Acceptance of participation in the study by signing the informed consent

排除标准

  • Patients who do not consent to participate in the study

结局指标

主要结局

Identifying disease clusters (defined as the co-presence of at least two additional diseases) in patients suffering from at least one of the following chronic diseases: heart failure, COPD, and chronic kidney disease

时间窗: 14 Months

IN-CluDiMI study primary objective was to map the structural patterns of disease clustering around HF, COPD, and CKD, and to evaluate their prevalence, functional impacts, and geographic distribution.We also investigated the prognostic role of these clusters on mortality (in-hospital and/or follow-up mortality). The analysis included all available comorbidities, excluding highly prevalent risk factors such as hypertension, diabetes mellitus and dyslipidaemia, which were analysed separately. The optimal number of clusters was determined using the silhouette index, selecting a solution that maximised cluster separation and internal cohesion. 3 complementary approaches were used to investigate co-occurrence patterns: 1. pairwise analyses 2. hierarchical analyses 3. a combinatorial analysis to identify the most prevalent triplets of co-occurring conditions within each disease-specific cohort This approach is considered the primary method for identifying recurrent multimorbidity patterns

次要结局

未报告次要终点

研究者

发起方
Fadoi Foundation, Italy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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