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

Primary Purpose

Alcohol Addiction, Mouth Diseases

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Drinksmeter
Brief Advice of Alcohol Use
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Addiction focused on measuring drinksmeter, alcohol counselling

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drinksmeter

Brief Advice of Alcohol Use

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction in mean number of alcohol units consumed per week
Number of weekly alcohol units will be recorded before intervention and 3-6 months after intervention

Secondary Outcome Measures

Improvement of AUDIT-10 (Alcohol Use Disorders Identification Test) Questionnaire Score
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.

Full Information

First Posted
February 16, 2015
Last Updated
September 10, 2019
Sponsor
King's College Hospital NHS Trust
Collaborators
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02374905
Brief Title
Testing Interventions to Reduce Alcohol Consumption Among Outpatients in a Dental Setting
Official Title
Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Staff changes and retirement of the primary investigator during the study
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Addiction, Mouth Diseases
Keywords
drinksmeter, alcohol counselling

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drinksmeter
Arm Type
Experimental
Arm Description
Web-based application delivering Identification and Brief Advice of Alcohol Use
Arm Title
Brief Advice of Alcohol Use
Arm Type
Active Comparator
Arm Description
Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician
Intervention Type
Device
Intervention Name(s)
Drinksmeter
Intervention Description
Web-based application delivering Identification and Brief Advice of Alcohol Use
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice of Alcohol Use
Intervention Description
Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician
Primary Outcome Measure Information:
Title
Reduction in mean number of alcohol units consumed per week
Description
Number of weekly alcohol units will be recorded before intervention and 3-6 months after intervention
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Improvement of AUDIT-10 (Alcohol Use Disorders Identification Test) Questionnaire Score
Description
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.
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saman Warnakulasuriya, BDS,PhD,DSc
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
King's College Hospital
City
London
State/Province
Lambeth
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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