Condition category
Mental and Behavioural Disorders
Date applied
08/08/2012
Date assigned
26/09/2012
Last edited
04/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
At present, apart from documenting the levels of alcohol intake, most dermatology clinics have not attempted to modify the drinking behaviour of patients. During the last 10 years, clinic based programmes have been developed to effectively lower alcohol consumption. These tools could be put to significant benefit in the dermatology clinics.
To deploy a successful programme, data on the drinking behaviour of patients is needed. Firstly we need to identify which groups of dermatology patients need to be targeted. We know that patients with psoriasis often drink heavily, however whether the alcohol is a trigger or a consequence of psychological distress is not known. There is very little information on whether patients with other inflammatory skin disease such as eczema or cutaneous lupus are also heavy drinkers. Rosacea is often thought to be linked to alcohol although good data is lacking. We also do not know whether non inflammatory skin diseases such as skin cancer influence alcohol consumption.

Who can participate?
Patients currently suffering from skin diseases , attending skin disease clinics in Newcastle upon Tyne, UK.

What does the study involve?
Firstly, we will do some preliminary, questionnaire based work in the dermatology clinics to identify which groups of patients are drinking above recommended levels. We will also explore the acceptability of asking about alcohol use in patients in the skin clinics. Data from each group of patients will be compared, to conclude if alcohol use disorders (AUDs) are more prevalent within patients with inflammatory skin disorders. To do this, we will utilise the 10 item one page AUDIT screening questionnaire to identify patients with AUDs. This information will allow the team to gather the necessary information to gauge the prevalence of the issue and work towards putting together a grant to test the effectiveness of brief interventions in this setting.

What are the possible benefits and risks of participating?
There are no immediate benefits for the participating in this study. Participation will be contribute to research which could be of possible future benefit to patients and others in the same circumstances. The analysis of the information gathered will allow a future research study to provide alcohol screening and a brief programme for patients with skin disease, in a dermatology clinic setting. For some patients, this research may immediately identify their own need for support in regards to their alcohol consumption, stress or anxiety.
There are no anticipated risks of participating within this research. However, some patients may feel some minor psychological stress when completing the questionnaires, due to the topic that they address.

Where is the study run from?
Royal Victoria Infirmary, Newcastle upon Tyne, UK

When is study starting and how long is it expected to run for?
The study is expected to start on 1 October 2012 and is expected to run for 2 years.

Who is funding the study?
The British Skin Foundation

Who is the main contact?
Dr Phillip Hampton
Philip.Hampton@nuth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Hampton

ORCID ID

Contact details

Royal Victoria Infirmary
Department of Dermatology
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12183

Study information

Scientific title

Examining the prevalence of alcohol use disorders (AUDs) in patients with skin disease: an observational study

Acronym

Study hypothesis

At present, apart from documenting the levels of alcohol intake, most dermatology clinics have not attempted to modify the drinking behaviour of patients in a meaningful way. Over the last 10 years short clinic based interventions have been developed which have been proven to effectively lower alcohol consumption. We feel that these tools could be put to significant benefit in the dermatology clinics. In order to deploy successful interventions, data on prevalence is needed. Firstly we need to identify which groups of dermatology patients need to be targeted. We know that patients with psoriasis often drink heavily, however whether the alcohol is a trigger or a consequence of psychological distress is not known.

There is very little information on whether patients with other inflammatory skin disease such as eczema or cutaneous lupus are also heavy drinkers. Rosacea is often thought to be linked to alcohol although good data is lacking. We also have no idea whether non inflammatory skin diseases such as skin cancer influence alcohol consumption. To enable us to target our intervention study successful we propose to do some preliminary questionnaire based work in the dermatology clinics to identify which groups of patients are drinking above recommended levels. We will also explore the acceptability of asking about alcohol use in both staff members and patients in the skin clinics.

We aim to use the 10 item one page Alcohol Use Disorders Identification Test (AUDIT) screening questionnaire to identify patients with AUDs, attending skin disease clinics in Newcastle. We also aim to ask patients whether, should it be offered, they would be willing to take part in brief clinic based interventions to lower alcohol consumption. This information will enable the team to gather the necessary information to gauge the prevalence of the issue and work towards putting together a grant to test the effectiveness of brief interventions in this setting.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12183

Ethics approval

NRES Committee North East - Sunderland, 25 May 2012, ref: 12/NE/0154

Study design

Observational pilot study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, to request patient information sheet please contact
Ms Bianca Tobin
Research Office
Dermatology Outpatient Department
Level 2, New Victoria Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
Tyne and Wear
NE1 4LP
Tel: +44 (0)191 28 23568

Condition

Alcohol use disorders

Intervention

This study will be a single site study, where patients who are attending the Dermatology outpatient department will be recruited. The full spectrum of skin diseases are seen in a variety of both general and specialised clinics and we aim to recruit approximately 720 patients in a 2 year period. There will be two main groups of patients targeted based on their skin disease diagnoses.

Group 1
We will recruit from the major inflammatory skin diseases psoriasis, eczema, lupus and a group of miscellaneous other inflammatory skin diseases in the following manner.
1. Psoriasis - 120 patients
2. Eczema - 120 patients
3. LUPUS - 120 patients
4. Other - 120 patients

Group 2
We will sample a reference population of 240 patients with non-inflammatory skin diseases. The reference population group will comprise of any patients with non inflammatory skin problems. This means patients with skin lesions or other structural skin problems where the skin is not inflamed or itchy. We will aim to recruit 240 patients in this group.

As well as collecting demographic data and data relating to the patients skin disease the questionnaire will include the following tools:- AUDIT, Hospital Anxiety and Depression Scale (HADS) and Dermatology Life Quality Index (DLQI).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To ascertain the prevalence of alcohol use disorders in a proportion of patients attending the dermatology out patient clinics using the Alcohol use disorders identification test (AUDIT).

Secondary outcome measures

1. To record the dermatology life quality index (DLQI) for each patient
2. To record the hospital anxiety and depression score (HADS) for each patient

Overall trial start date

01/10/2012

Overall trial end date

30/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be recruited into one of two groups:

Group1
1. A diagnosed inflammatory skin disease made by a dermatologist
2. Aged between 18 and 75 years inclusive
3. Male or Female
4. Able to provide written informed consent

Group2
1. A diagnosed non-inflammatory skin disease made by a dermatologist
2. Aged between 18 and 75 years inclusive
3. Male or Female
4. Ability to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 720

Participant exclusion criteria

1. Patients under the age of 18 years
2. Patients who are unable to give written informed consent
3. Male & female

Recruitment start date

01/10/2012

Recruitment end date

30/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Midwifery Research Department
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

British Skin Foundation (UK)

Alternative name(s)

BSF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Publication citations

Additional files

Editorial Notes