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

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ClinicalTrials.gov Identifier: NCT02374905
Recruitment Status : Terminated (Staff changes and retirement of the primary investigator during the study)
First Posted : March 2, 2015
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
Saman Warnakulasuriya, King's College Hospital NHS Trust

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.

Condition or disease Intervention/treatment Phase
Alcohol Addiction Mouth Diseases Device: Drinksmeter Behavioral: Brief Advice of Alcohol Use Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic
Study Start Date : October 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Drinksmeter
Web-based application delivering Identification and Brief Advice of Alcohol Use
Device: Drinksmeter
Web-based application delivering Identification and Brief Advice of Alcohol Use

Behavioral: 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
Behavioral: Brief Advice of Alcohol Use
Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374905


Locations
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United Kingdom
King's College Hospital
London, Lambeth, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
South London and Maudsley NHS Foundation Trust
Investigators
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Study Director: Saman Warnakulasuriya, BDS,PhD,DSc King's College London

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Responsible Party: Saman Warnakulasuriya, Professor and consultant, King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02374905     History of Changes
Other Study ID Numbers: KCH 14-158
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Keywords provided by Saman Warnakulasuriya, King's College Hospital NHS Trust:
drinksmeter
alcohol counselling

Additional relevant MeSH terms:
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Mouth Diseases
Alcohol Drinking
Alcoholism
Drinking Behavior
Stomatognathic Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs