Excessive DrinkingEFAR-FVGNCT01638338
Risky Drinkers and the Web: a RCT Study in Region Friuli-Venezia Giulia.
A study testing Web assisted brief motivational interview on risky drinking and Face to Face in people with Excessive Drinking, run by Azienda Per I Servizi Sanitari N. 2 Isontina at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Drinking
- What is being tested?
- Web assisted brief motivational interview on risky drinking and Face to Face
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2012to 30 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Excessive Drinking
- Being tested
- Web assisted brief motivational interview on risky drinking, Face to Face
- Keywords
- Alcohol, Risky drinking, Web site, Primary Care, General Practice, Local Community, Mayors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web assisted brief motivational interview on risky drinkingBehavioural
Also called Codeface Ltd.
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
Face to FaceBehavioural
Also called Screening and Brief intervention, EIBI, SBI
The counseling provided by the GPs will be done at month 0, 6, 12
| Study group | Role | What they receive |
|---|---|---|
| Web site | Experimental | 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 Receives: Behavioral: Web assisted brief motivational interview on risky drinking |
| Face to Face | Experimental | Risky drinking brief motivational interview provided by the GP. Receives: Behavioral: Face to Face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption reduction: Full AUDIT (10 questions)
This measure is referred to the alcohol use reduction
Measured: up to one year
Secondary outcomes (1)
Economic evaluation
The EQ-5D 5L quality-of-life questionnaire, validated Italian version
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study start1 Dec 2012
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Excessive DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Per I Servizi Sanitari N. 2 Isontina
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy, Istituto Superiore di Sanità, University of Leeds, Federsanità, ANCI, Codeface Ltd.
- Responsible party
- Principal investigator, Pierluigi Struzzo, MD, Azienda Per I Servizi Sanitari N. 2 Isontina
- Investigators
- Paul Wallace, prof, Study director, Leeds UniversityEmanuele Scafato, prof, Study chair, Istituto Superiore di Sanità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638338
- Sponsor's protocol ID
- RF-2010-2318620
- Acronym
- EFAR-FVG
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2012
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hunter R, Wallace P, Struzzo P, Vedova RD, Scafuri F, Tersar C, Lygidakis C, McGregor R, Scafato E, Freemantle N. Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website: cost-effectiveness analysis. BMJ Open. 2017 Nov 3;7(11):e014577. doi: 10.1136/bmjopen-2016-014577.
PubMed 29102983Wallace P, Struzzo P, Della Vedova R, Scafuri F, Tersar C, Lygidakis C, McGregor R, Scafato E, Hunter R, Freemantle N. Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website. BMJ Open. 2017 Nov 3;7(11):e014576. doi: 10.1136/bmjopen-2016-014576.
PubMed 29102982Lygidakis C, Wallace P, Tersar C, Marcatto F, Ferrante D, Della Vedova R, Scafuri F, Scafato E, Struzzo P. Download Your Doctor: Implementation of a Digitally Mediated Personal Physician Presence to Enhance Patient Engagement With a Health-Promoting Internet Application. JMIR Res Protoc. 2016 Mar 4;5(1):e36. doi: 10.2196/resprot.5232.
PubMed 26944482
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing and Integrating the Delivery of Primary Care Services for Risky Drinkers in Region Friuli-Venezia Giulia
- ClinicalTrials.gov ID
- NCT01638338
- Acronym / sponsor ID
- EFAR-FVG / RF-2010-2318620
- Conditions
- Excessive Drinking
- Keywords
- Alcohol, Risky drinking, Web site, Primary Care, General Practice, Local Community, Mayors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Azienda Per I Servizi Sanitari N. 2 IsontinaUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy, Istituto Superiore di Sanità, University of Leeds, Federsanità, ANCI, Codeface Ltd.
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web site | Experimental | Behavioral: Web assisted brief motivational interview on risky drinkingA 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 |
| Face to Face | Experimental | Behavioral: Face to FaceRisky drinking brief motivational interview provided by the GP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web assisted brief motivational interview on risky drinkingAlso: Codeface Ltd.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 | Behavioural | Web site |
| Face to FaceAlso: Screening and Brief intervention, EIBI, SBIThe counseling provided by the GPs will be done at month 0, 6, 12 | Behavioural | Face to Face |
Primary outcome
Alcohol consumption reduction: Full AUDIT (10 questions)
Time frame: up to one year
This measure is referred to the alcohol use reduction
1 secondary outcome
Economic evaluation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Derived from this study: PubMed 29102983Hunter R, Wallace P, Struzzo P, Vedova RD, Scafuri F, Tersar C, Lygidakis C, McGregor R, Scafato E, Freemantle N. Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website: cost-effectiveness analysis. BMJ Open. 2017 Nov 3;7(11):e014577. doi: 10.1136/bmjopen-2016-014577.
- Derived from this study: PubMed 29102982Wallace P, Struzzo P, Della Vedova R, Scafuri F, Tersar C, Lygidakis C, McGregor R, Scafato E, Hunter R, Freemantle N. Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website. BMJ Open. 2017 Nov 3;7(11):e014576. doi: 10.1136/bmjopen-2016-014576.
- Derived from this study: PubMed 26944482Lygidakis C, Wallace P, Tersar C, Marcatto F, Ferrante D, Della Vedova R, Scafuri F, Scafato E, Struzzo P. Download Your Doctor: Implementation of a Digitally Mediated Personal Physician Presence to Enhance Patient Engagement With a Health-Promoting Internet Application. JMIR Res Protoc. 2016 Mar 4;5(1):e36. doi: 10.2196/resprot.5232.
- Centre for the training in primary careLink provided by the sponsor.
Related trials for Excessive Drinking
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Barbershop Talk: Reducing Excessive Alcohol Consumption Among Men
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Not yet recruiting
Substance Use Screening to Encourage Behavior Change Among Young People in Primary Care
Substance Use, Binge Drinking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Wallace, prof study director
Leeds University
Emanuele Scafato, prof study chair
Istituto Superiore di Sanità
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web assisted brief motivational interview on risky drinking and Face to Face in people with Excessive Drinking, run by Azienda Per I Servizi Sanitari N. 2 Isontina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption reduction: Full AUDIT (10 questions) (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01638338, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.