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临床试验/NCT07675447
NCT07675447已完成不适用

Integrated Digital System for Screening and Brief Intervention to Reduce Harmful Alcohol Consumption - PROSA eTIB

InCor Heart Institute1 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2024年2月15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
516
试验地点
1
主要终点
Rate of harmful alcohol consumption (HAC)

研究概览

简要总结

This epidemiological study (randomized clinical trial) aims to evaluate a digital Screening and Brief Intervention (e-SBI) system for reducing and preventing harmful alcohol consumption in patients treated by the Brazilian Unified Health System (SUS), compared to an in-person SBI protocol.

详细描述

Introduction / Background Harmful alcohol consumption (HAC) is defined as an alcohol intake exceeding 14 standard drinks per week for men and 7 standard drinks per week for women, or the consumption of 5 or more drinks on a single occasion for men and 4 or more drinks for women (binge drinking). This pattern of consumption is termed "harmful" due to its well-established association with significant social, economic, and health-related risks.

According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), one standard drink corresponds to 14 grams of pure alcohol, which is contained in one can of beer (355 ml), one glass of wine (150 ml), or one shot of distilled spirits (45 ml).

The observational clinical study entitled PROSA - Health & Alcohol Project - Evaluation of Alcohol Consumption Patterns in Heart Disease Patients and Non-Heart Disease Individuals has previously demonstrated that poor lifestyle habits are significantly associated with harmful alcohol consumption in both patients with heart disease and individuals without heart disease.

Since 1951, the World Health Organization (WHO) has actively promoted actions to combat harmful alcohol use. In 2018, the WHO launched the SAFER program, an acronym representing the five most effective evidence-based interventions against harmful alcohol use: 1) Strengthen restrictions on alcohol availability; 2) Advance and enforce drink-driving countermeasures; 3) Facilitate access to screening, brief interventions, and treatment; 4) Enforce bans or comprehensive restrictions on alcohol advertising, sponsorship, and promotion; 5) Raise prices on alcohol through excise taxes and pricing policies.

Among these interventions, Screening and Brief Intervention (SBI), which corresponds to item 3 of the SAFER initiative, is endorsed by both the WHO and the U.S. Centers for Disease Control and Prevention (CDC). The AUDIT (Alcohol Use Disorders Identification Test) is the recommended instrument for classifying the risk associated with alcohol consumption within SBI protocols.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • agree to participate in the study by signing the informed consent form and be over 18 years of age

排除标准

  • Not agreeing to participate in the study and being under 18 years of age.

结局指标

主要结局

Rate of harmful alcohol consumption (HAC)

时间窗: 6 months

Rate of use and adherence to the SBI in preson and in electronic arm - defined as the proportion of participants randomized who complete all SBI or e-SBI components.

次要结局

  • adherence to the electronic SBI(6 months)
  • amount of alcohol use(6 months)

研究者

发起方
InCor Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martino Martinelli Filho

Principal Investigator

InCor Heart Institute

研究点 (1)

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