Testing Interventions to Reduce Alcohol Consumption Among Outpatients in a Dental Setting

September 10, 2019 updated by: Saman Warnakulasuriya, King's College Hospital NHS Trust

Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic

The investigators wish to investigate the feasibility of using a web based drinking app (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient clinic in a dental setting.

Study Overview

Detailed Description

Any intervention on alcohol use is relevant to patients attending an oral medicine clinic, as alcohol can contribute to/or worsen mouth disorders. For example, research confirms that white and red patches of the lining of the mouth in regular tobacco and alcohol users can change to mouth cancer. Many people do not know that drinking alcohol would increase their mouth cancer risk.

Any new or follow-up patients attending our clinic and reporting drinking over the recommended guidelines (as given by European Code Against Cancer) will be eligible to participate. The study will start on the first visit to the clinic and/or at their follow-up visit. For each volunteer the study will last 3 months. Participants will be allocated to two groups, those receiving routine brief counselling on the day of their visit and those to whom a web-based electronic tool to self-assess is introduced. They will be motivated to use it in the following weeks to reduce consumption . The study will evaluate alcohol consumption levels using tested questionnaires at base-line and exit.

The investigators will assess the feasibility of the use of an electronic tool in our study population, whether it provided better outcomes compared to standard care.

Study Type

Interventional

Enrollment (Actual)

10

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

    • Lambeth
      • London, Lambeth, United Kingdom, SE5 9RS
        • King's College Hospital

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

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient attending the Department of Oral Medicine at King's College Hospital and consuming alcohol over recommended guidance (European Code Against Cancer)

Exclusion Criteria:

  • Patient which cannot understand English
  • Complete lack of IT literacy
  • Patient in contact with a specialized alcohol service

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: Drinksmeter
Web-based application delivering Identification and Brief Advice of Alcohol Use
Web-based application delivering Identification and Brief Advice of Alcohol Use
Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician
Active Comparator: Brief Advice of Alcohol Use
Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician
Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in mean number of alcohol units consumed per week
Time Frame: 6-12 months
Number of weekly alcohol units will be recorded before intervention and 3-6 months after intervention
6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of AUDIT-10 (Alcohol Use Disorders Identification Test) Questionnaire Score
Time Frame: 6-12 months
AUDIT-10 questionnaire given before and after intervention. A total score is given for the questionnaire based on the answers given. This total score will be compared before and after.
6-12 months

Collaborators and Investigators

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

Investigators

  • Study Director: Saman Warnakulasuriya, BDS,PhD,DSc, King's College London

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

October 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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