Condition category
Oral Health
Date applied
04/10/2011
Date assigned
09/11/2011
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and aims
People with mental illness tend to have more dental problems than people without. Oral health problems are not well recognised by mental health professionals and when treatment is accessed, people with mental illnesses generally experience barriers to treatment.
The aim of this study is to see whether a simple checklist can improve the oral health of people with serious mental illness.

Who can participate?
Anyone aged over 18 years old who is cared for by an ‘Early intervention in Psychosis’ team in Nottinghamshire, Derbyshire or Lincolnshire can take part.

What does the study involve?
‘Early Intervention in Psychosis’ teams will be randomly allocated to receive either dental awareness training for care coordinators plus using a dental health checklist with standard care or to standard care alone. All service users within the same team will receive the same intervention.

What are the possible benefits and risks of participating?
If service users agree to complete the checklist, they will gain more information about how to look after their teeth. We do not think there will be any negative side effects from the checklist.
Only people who are cared for by one of the teams on the day during which we allocate participants to one of the treatments will be able to take part, but if the checklist is found to improve the oral health of the people who completed it, every person cared for by the teams will be given the opportunity to use the checklist.

Where is the study run from?
Within psychosis teams in Nottinghamshire, Derbyshire and Lincolnshire (UK). and will be delivered as part of standard care.

When is study starting and how long is it expected to run for?
The trial started in October 2011 and will run for one year.

Who is funding the study?
The study is funded by National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC).

Who is the main contact?
Ms Hannah Jones (Research Assistant)
Hannah.Jones@Nottingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Clive E Adams

ORCID ID

Contact details

Cochrane Schizophrenia Group
Sir Colin Campbell Building
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom
+44 (0)115 823 1274
clive.adams@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10105

Study information

Scientific title

The three Shires early intervention dental trial

Acronym

Study hypothesis

To examine whether dental awareness training plus an oral health checklist will improve the oral health of the "Early Intervention in Psychosis" population in the East Midlands, United Kingdom

Ethics approval

NRES Committee East Midlands, 1 Nottingham 11 August 2011, ref: 11/EM/0205

Study design

Multicentre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Oral health

Intervention

Team dental awareness training plus an oral health checklist plus standard care versus standard care alone

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Visit to dentist within one year of exposure to checklist

Secondary outcome measures

1. Registration with a dentist
2. Frequency of tooth brushing
3. Reason for dental visit (routine vs for problem)
4. Quality of life
5. Economic data
6. Leaving the study

Overall trial start date

01/10/2011

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any willing early intervention in psychosis team in Nottinghamshire, Derbyshire or Lincolnshire
2. Service users cared for by the care coordinators within these teams aged over 18 years old at randomisation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600-800

Participant exclusion criteria

1. Any early intervention in psychosis team that does not wish to take part
2. Any individual care coordinator or service user within a team that does not wish to take part
3. Any service user aged less than 18 years old at randomisation

Recruitment start date

01/10/2011

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cochrane Schizophrenia Group
Nottingham
NG7 2TU
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
King’s Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23714397

Publication citations

  1. Protocol

    Jones HF, Adams CE, Clifton A, Simpson J, Tosh G, Liddle PF, Callaghan P, Yang M, Guo B, Furtado V, An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial., Trials, 2013, 14, 158, doi: 10.1186/1745-6215-14-158.

Additional files

Editorial Notes