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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02374905
Other study ID # KCH 14-158
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date August 2018

Study information

Verified date September 2019
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United Kingdom King's College Hospital London Lambeth

Sponsors (2)

Lead Sponsor Collaborator
King's College Hospital NHS Trust South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6-12 months
Secondary 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. 6-12 months
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