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Risky Drinkers and the Web: a RCT Study in Region Friuli-Venezia Giulia. (EFAR-FVG)

2017年7月4日 更新者:Pierluigi Struzzo, MD、Azienda Per I Servizi Sanitari N. 2 Isontina

Optimizing and Integrating the Delivery of Primary Care Services for Risky Drinkers in Region Friuli-Venezia Giulia

The project aims to develop a new approach to risky drinkers by providing a facilitated website access and creating a local integrated support network.

In order to do so:

1) A non inferiority-randomised controlled study will be performed to test the hypothesis that: Brief intervention for risky drinkers delivered in primary care through facilitated access to an alcohol reduction website has non inferior outcomes to face to face brief intervention.

研究概览

详细说明

Far from being only an Italian problem, harmful alcohol consumption puts a heavy burden on people's health. Risky behaviors and socio-economical conditions are closely linked and, thus, during critical economical periods, such as this, alcohol related problems increase significantly.

Screening and Brief Intervention is a very effective method to screen and counsel risky people at primary care level but, nevertheless, general practitioners and other health care professionals don't utilize it.

This is mainly due to the fact that the National Health Services should include it into financial agreements for reimbursement or adopt other incentives that, in this critic period, are difficult to be taken into consideration.

What are the alternatives? Utilizing existing resources to propose a different approach at little or no cost: the web and the local communities.

Computers are in almost every house and, if not, the local community can offer their use within libraries or social centres.

Computers are definitely utilized by young people and youngsters are the first to suffer from risky alcohol use. Older people are more and more using them maybe just to surf the web but, if not, its use could be facilitated by their general practitioners.

As stated before, no scientific evidence exists on its effectiveness in respect to the GPs work. For this reason we decided to compare the efficacy of a web based "brief intervention" with a face-to-face brief intervention performed by general practitioners.

We would like to see if a web based approach is, at least, as good as, or not inferior to GPs work.

This project could have an important impact at regional and national level. It could be the starting point of a different way to provide alcohol related health services, utilizing up to date working tools, such as smart phones or iPads, giving a different role to the GPs and improving the action of local social services.

The work of general practitioners could also benefit and more integration with the territorial services could bring to increased visibility of Local Authorities.

The supervision of national and international high-level experts will assure an outstanding quality to the project and the possibility of future inclusion of its results within national or international guidelines for primary care alcohol related services.

This study is a part of a wider community program aiming at involving GPs and Local Authorities for its implementation whose objectives are out of the scope of this RCT.

研究类型

介入性

注册 (实际的)

674

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Monfalcone、意大利、34074
        • Regional Centre for the Training in Primary Care

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All patients scoring above the agreed cut-point (AUDIT-C: 5 for men and 4 for women) will be invited by their GP to use the trial online consent and assessment module

Exclusion Criteria:

  • Patients aged less than 18 years and those who do not give consent will be excluded from the trial and encouraged on-line to make an appointment with their doctor to discuss their drinking habits. Those whose scores indicate dependence will also be excluded from the trial and encouraged on-line to seek additional medical support including referral to a specialist agency

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Web site

A specific web site for randomization and risky alcohol consumption counseling will be beta tested and created. Risky drinkers allocated to this arm will receive web assisted brief motivational interview.

They will first be assessed towards risky alcohol consumption and Quality of life (AUDIT and EQ5D). Personal health status will also be assessed with a Likert scale. Brief Intervention will be administered following a consistent number of web pages reporting brief motivational interview Web assisted brief motivational interview on risky drinking

People allocated to this arm will be given a password to enter and follow a pre-decided set of questions and hints to reduce their drinking
其他名称:
  • Codeface Ltd.
实验性的:Face to Face
Risky drinking brief motivational interview provided by the GP.
The counseling provided by the GPs will be done at month 0, 6, 12
其他名称:
  • 执行局
  • Screening and Brief intervention
  • EIBI

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Alcohol consumption reduction: Full AUDIT (10 questions)
大体时间:up to one year
This measure is referred to the alcohol use reduction
up to one year

次要结果测量

结果测量
措施说明
大体时间
Economic evaluation
大体时间:one year
The EQ-5D 5L quality-of-life questionnaire, validated Italian version
one year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Paul Wallace, prof、Leeds University
  • 学习椅:Emanuele Scafato, prof、Istituto Superiore di Sanità

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年12月1日

初级完成 (实际的)

2015年12月30日

研究完成 (实际的)

2015年12月30日

研究注册日期

首次提交

2012年7月3日

首先提交符合 QC 标准的

2012年7月9日

首次发布 (估计)

2012年7月11日

研究记录更新

最后更新发布 (实际的)

2017年7月6日

上次提交的符合 QC 标准的更新

2017年7月4日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • RF-2010-2318620

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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