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

July 4, 2017 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

674

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monfalcone, Italy, 34074
        • Regional Centre for the Training in Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: 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
Other Names:
  • Codeface Ltd.
Experimental: Face to Face
Risky drinking brief motivational interview provided by the GP.
Behavioral: Face to Face
The counseling provided by the GPs will be done at month 0, 6, 12
Other Names:
  • SBI
  • Screening and Brief intervention
  • EIBI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Per I Servizi Sanitari N. 2 Isontina

Collaborators

University of Leeds
Istituto Superiore di Sanità
Ministry of Health, Italy
Federsanità, ANCI
Codeface Ltd.

Investigators

  • Study Director: Paul Wallace, prof, Leeds University
  • Study Chair: Emanuele Scafato, prof, Istituto Superiore di Sanità

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

December 30, 2015

Study Completion (Actual)

December 30, 2015

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RF-2010-2318620

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Excessive Drinking

Clinical Trials on Web assisted brief motivational interview on risky drinking

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe