NCT01638338

Brief 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 primary care through facilitated access to an alcohol reduction website has non inferior outcomes to face to face brief intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
674

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

3.1 years

First QC Date

July 3, 2012

Last Update Submit

July 4, 2017

Conditions

Excessive Drinking

Keywords

AlcoholRisky drinkingWeb sitePrimary CareGeneral PracticeLocal CommunityMayors

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption reduction: Full AUDIT (10 questions)

    This measure is referred to the alcohol use reduction

    up to one year

Secondary Outcomes (1)

  • Economic evaluation

    one year

Study Arms (2)

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

Behavioral: Web assisted brief motivational interview on risky drinking

Face to Face

EXPERIMENTAL

Risky drinking brief motivational interview provided by the GP.

Behavioral: Face to Face

Interventions

Web assisted brief motivational interview on risky drinkingBEHAVIORAL

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

Also known as: Codeface Ltd.
Web site
Face to FaceBEHAVIORAL

The counseling provided by the GPs will be done at month 0, 6, 12

Also known as: Screening and Brief intervention, EIBI, SBI
Face to Face

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Centre for the Training in Primary Care

Monfalcone, 34074, Italy

Location

Related Publications (3)

  • 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.

    PMID: 29102983DERIVED

  • Wallace 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.

    PMID: 29102982DERIVED

  • Lygidakis 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.

    PMID: 26944482DERIVED

Related Links

MeSH Terms

Interventions

Crisis Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Paul Wallace, prof

    Leeds University

    STUDY DIRECTOR

  • Emanuele Scafato, prof

    Istituto Superiore di Sanità

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 11, 2012

Study Start

December 1, 2012

Primary Completion

December 30, 2015

Study Completion

December 30, 2015

Last Updated

July 6, 2017

Record last verified: 2017-07

Locations

IT(1)