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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Excessive Drinking

Intervention / Treatment
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* Behavioral: Web assisted brief motivational interview on risky drinking
* Behavioral: Face to Face


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web site<br>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 | Behavioral: Web assisted brief motivational interview on risky drinking<br>* 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<br>* Other names: Codeface Ltd.;|
| Experimental: Face to Face<br>Risky drinking brief motivational interview provided by the GP. | Behavioral: Face to Face<br>* The counseling provided by the GPs will be done at month 0, 6, 12<br>* Other names: SBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol consumption reduction: Full AUDIT (10 questions) | This measure is referred to the alcohol use reduction | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic evaluation | The EQ-5D 5L quality-of-life questionnaire, validated Italian version | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, Risky drinking, Web site, Primary Care, General Practice, Local Community, Mayors