NCT06363617已完成不适用
Implementation of the Fatty Liver Index in Primary Care for Patients at Risk of Hepatic Steatosis to Optimize Clinical Control: Randomized Clinical Trial
Consorci Sanitari de l'Alt Penedès i Garraf2 个研究点 分布在 1 个国家目标入组 434 人开始时间: 2024年5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
- 434
- 试验地点
- 2
- 主要终点
- Lifestyle Intervention
研究概览
简要总结
This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 14 years and older.
- •Attended at the Basic Care Units (BCU) participating in the Primary Care Center Baix a Mar study.
- •Intention to undergo medical follow-up at the study center.
- •Body mass index ≥ 25.
排除标准
- •Pregnant women
- •Alcohol consumption habit (Standard Drink Unit (SDU); one SDU equals 10 grams of alcohol. Risky consumption is considered from 4 SDUs in men and 2 SDUs in women).
- •Displaced patients not assigned to the study center.
- •Patients classified as Advanced Chronic Care Model or Complex Chronic Patient.
- •Participants diagnosed with any of the following pathologies: Chronic liver diseases, including hepatic steatosis; Dementia; Active oncological diseases
- •Cognitive or affective pathology that limits the ability to collaborate with lifestyle interventions carried out at the center.
- •Patients under the care of endocrinology specialists.
- •Participation in another clinical trial involving an experimental intervention during the period of this trial.
结局指标
主要结局
Lifestyle Intervention
时间窗: Month 6
Percentage of participants receiving a lifestyle intervention from the start of the study to month 6
次要结局
- FLI administration(Month 12)
- Analytical checks in the first year(Month 12)
- Gamma-glutamyl transpeptidase(Month 12)
- Medical and nursing visits(Month 12)
- Triglycerides(Month 12)
- Low-density lipoprotein cholesterol(Month 12)
- Lipid-lowering drugs(Month 12)
- Healthcare spending(Month 12)
研究者
研究点 (2)
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