- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02374905
Testing Interventions to Reduce Alcohol Consumption Among Outpatients in a Dental Setting
Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lambeth
-
London, Lambeth, United Kingdom, SE5 9RS
- King's College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Study Director: Saman Warnakulasuriya, BDS,PhD,DSc, King's College London
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCH 14-158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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