Condition category
Mental and Behavioural Disorders
Date applied
04/10/2013
Date assigned
04/10/2013
Last edited
08/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Alcohol misuse is an important public health problem in the UK. There are evidences about the how well brief alcohol interventions given in GP surgeries. No studies have however been conducted to find out how well these work in general dental practice. Excessive alcohol consumption is a major risk factor for oral cancer, injury and dental erosion. The majority of the UK adult population visits a dentist within a two year period. This provides a unique opportunity to give preventive advice to dental patients to promote both their oral and general health. Increasingly general dental practitioners ask their patients about their tobacco and alcohol habits but few dentists offer brief alcohol advice to patients who are drinking excessively. The aim of the study is to find out the acceptability and feasibility of giving a brief alcohol intervention.

Who can participate?
Any adult patient with a positive alcohol screening result attending the participating dental practice can participate in the study.

What does the study involve?
Participating dental practices will be randomly allocated to one of two groups: control and intervention practices. In control practices participants will be given an oral cancer prevention leaflet about reducing alcohol intake and stopping smoking. Participants attending the intervention practices will be given up to five minutes of brief advice about alcohol consumption. All participants will be contacted through telephone after 6 months. At the end of the study all participants will be sent a summary of the study results and an information leaflet on responsible alcohol consumption.

What are the possible benefits and risks of participating?
Participants in the intervention group will potentially benefit through changing their alcohol consumption pattern. Those attending the other dental surgeries will still receive standard advice and support from dental teams and at the end of the study they will also receive the brief advice. No additional appointments will be required for the study. All participants will be sent by post a £10 gift token after they complete the 6 month follow up phone call. In this study the intervention is non-invasive in nature but alcohol is a sensitive issue. Carefully designed procedures and policies will be developed to minimise participants' potential feelings of guilt or pressure and their time involvement.

Where is the study run from?
The study is being conducted in the general dental practices across North Central London, UK.

When is the study starting and how long is it expected to run for?
August 2013 to February 2016.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Professor Richard Watt: r.watt@ucl.ac.uk
Ms Antiopi Ntouva: a.ntouva@ucla.c.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Antiopi Ntouva

ORCID ID

Contact details

UCL Department of Epidemiology and Public Health
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
+44 (0)20 7679 1703
a.ntouva@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15167; PBPG021227029

Study information

Scientific title

An exploratory cluster randomized controlled trial of brief alcohol advice delivered in general dental practice

Acronym

DART (Dental Alcohol Reduction Trial)

Study hypothesis

We are hypothesizing that the brief advice intervention will be more effective at reducing alcohol consumption than the standard advice currently given at dental surgeries.

Ethics approval

Camden and Islington REC, 22/04/2013, Ref: 13/LO/0292

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Alcohol consumption

Intervention

In the control practices participants who have a positive screening result will be initially given an oral cancer prevention leaflet which includes brief guidance on reducing alcohol intake and stopping smoking.

Participants attending the intervention practices who have a positive screening result will be given up to five minutes of simple structured brief advice using the Screening and Intervention Programme for Sensible drinking (SIPS) brief advice tool 'Brief advice about alcohol risk' which was based on the Simple Structured Advice intervention tool as part of the UK version of the WHO collaborative Drink Less brief intervention programme. To support and reinforce the advice, the Department of Health leaflet 'How much is too much?' will also be given.

Any participants in either the control or intervention groups who are identified as being alcohol dependent will be referred to local services for help.

After all the follow-up data has been collected, those participants attending the control practices who had a positive screening result will then also be offered the 5 minute brief advice and given a copy of the Department of Health alcohol leaflet.

Secondary sponsor:
Professor Richard G Watt

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Score on Extended AUDIT questionnaire cut off 8 or more as used in SIPS programme measured at baseline and 6 months

Secondary outcome measures

1. Mean weekly units of alcohol consumed during the previous 90 days using the Form 90
2. Average drinks (8 mg of pure ethanol) per day
3. Percentage days abstinent from work due to alcohol
4. Readiness to change measured by modified readiness to change ruler
5. Health related quality of life measure using EQ5D
All outcomes measured at baseline and 6 months

Overall trial start date

12/08/2013

Overall trial end date

12/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient with a positive screening result on Fast Alcohol Screening Test (FAST), aged 18 years or above, attending dental practice and able to speak, read and write English sufficiently well to complete study questionnaires/interviews.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

248 - 200 for main intervention and 48 for the exploratory and process evaluation focus groups.

Participant exclusion criteria

Patients already involved in any research study conducted in dental practice and those seeking help for alcohol dependence will be excluded

Recruitment start date

12/08/2013

Recruitment end date

12/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Department of Epidemiology and Public Health
London
WC1E 7HB
United Kingdom

Sponsor information

Organisation

Central and North West London NHS Foundation Trust (UK)

Sponsor details

Greater London House
Hampstead Road
London
NW1 7QY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Patient Benefit Programme; Ref: PBPG021227029

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26443659

Publication citations

Additional files

Editorial Notes