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
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
paul.cartledge@nottingham.ac.uk
Sponsor type
University/education
Website
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
-
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.